TMDA/DMC/MDC/G/005

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF

IN VITRO DIAGNOSTIC DEVICES

(Made under Section 52(1) of the Tanzania Medicines and Medical Devices Act, 2003)

THIRD EDITION

APRIL, 2020

P. O. Box 1253, Makole Street, PSSSF Building, 7th Floor, Dodoma

P.O. Box 77150, Off Mandela Road, Mabibo-External, Dar es Salaam
Tel: +255-22- 2450512/2450751/2452108, +255 68 445222/777 700002/685 701735
Fax: +255-22-2450793, Website: www.tmda.go.tz, Email: info@tmda.go.tz

Hotline: 0800110084
 CONTENTS

ABBREVIATIONS .........................................................................................................................4
ACKNOWLEDGEMENTS...........................................................................................................5
FOREWORD ..................................................................................................................................6
INTRODUCTION .........................................................................................................................7
DEFINITION OF TERMS .............................................................................................................8
1.0 GENERAL REQUIREMENTS ........................................................................................13
1.1 Applicant ........................................................................................................................13
1.2 Local responsible person ..............................................................................................13
1.3 Classification of IVDD ..................................................................................................13
1.3.2 Software ..................................................................................................................15
1.4 First time application ....................................................................................................15
1.5 Documentation ..............................................................................................................15
1.5.1 Language ................................................................................................................15
1.5.2 Requirements for Class A IVDDs .......................................................................15
1.5.3 Requirements for Class B, C and D IVDDs .......................................................16
1.5.4 Paper type and binding ........................................................................................16
1.6 Payment of fees, screening and processing of applications.....................................16
1.6.1 Payment of fees .....................................................................................................16
1.6.2 Processing of applications....................................................................................17
1.6.3 Performance evaluation .......................................................................................17
1.7 Registration of the device .............................................................................................17
1.7.1 Validity of registration .........................................................................................18
1.7.2 Termination of registration..................................................................................18
1.8 Application for variation of a registered device .......................................................18
1.9 Applications for renewal of registration ....................................................................19
1.10 Compilation of the dossier ...........................................................................................19
1.11 Evidence of compliance to Quality Management System .......................................19
1.12 Appeals ...........................................................................................................................20
2.0 SUBMISSION REQUIREMENTS ...................................................................................21
2.1 Submission requirements for Class A IVDDs ...........................................................21
2.2 Submission requirements for Class B, C and D IVDDs ...........................................22
3.0 SUMMARY TECHNICAL DOCUMENTATION ........................................................24
3.1 Device description and features ..................................................................................24
3.2 Evidence of conformity to Essential Principles .........................................................25
3.3 Risk analysis ...................................................................................................................26
3.4 Design and manufacturing information ....................................................................27
3.4.1 Product design .......................................................................................................27
3.4.2 Formulation and composition .............................................................................27
3.4.3 Manufacturing processes .....................................................................................28
3.5 Device Specifications .....................................................................................................29
3.5.1 Device validation and verification .....................................................................30
3.5.2 Specimen type........................................................................................................30
3.6 Analytical performance characteristics ......................................................................31
3.6.1 Accuracy of measurement ...................................................................................31
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 3.6.2 Analytical sensitivity ............................................................................................32
3.6.3 Analytical specificity ............................................................................................32
3.6.4 Metrological traceability of calibrator and control material values ..............33
3.7 Stability (excluding specimen stability) .....................................................................33
3.7.1 Claimed shelf life ..................................................................................................33
3.7.2 In use stability........................................................................................................34
3.7.3 Shipping stability ..................................................................................................34
3.7.4 Robustness studies ................................................................................................34
3.8 Software verification and validation (if applicable) .................................................36
3.9 Clinical performance .....................................................................................................36
4.0 LABELLING REQUIREMENTS .....................................................................................38
4.1 Labels...............................................................................................................................38
4.2 Instructions for use ........................................................................................................39
4.3 Instrument manual ........................................................................................................41
4.4 Any other instruction material provided to the user ...............................................41
Annex I .........................................................................................................................................42
Annex II ........................................................................................................................................47
Annex III ........................................................................................................................... 51
Annex IV ........................................................................................................................... 52
Annex V ........................................................................................................................................54
Annex VI.......................................................................................................................................59
Annex VII .....................................................................................................................................78

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 ABBREVIATIONS

AHWP - Asian Harmonization Working Party

CSDT - Common Submission Dossier Template

CSF - Cerebrospinal Fluid

DoC - Declaration of Conformity

EPSP - Essential Principles of Safety and Performance

GMDN - Global Medical Devices Nomenclature

HAS - Health Sciences Authority

IMDRF - International Medical Devices Regulator’s Forum

ISO - International Organization for Standardization

IVDD - In Vitro Diagnostic Device

LRP - Local Responsible Person

MoHCDGEC - Ministry of Health, Community Development, Gender, Elderly and Children

MSD - Medical Stores Department

PHLB - Private Health Laboratories Board

QMS - Quality Management System

STED - Summary Technical Documentation

TBS - Tanzania Bureau of Standards

TMDA - Tanzania Medicines and Medical Devices Authority

TMDCA - Tanzania Medicines and Medical Devices Authority Act, Cap 219

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 ACKNOWLEDGEMENTS

This is the third edition of the Guidelines on Submission of Documentation for Registration of In-Vitro
Diagnostic Medical Devices superseding the second version, which was in use since May, 2018. The
guidelines have been revised as a result of the Financial Act of 2019 which removed food and
cosmetic products from the regulatory mandate of the then Tanzania Food and Drugs Authority
(TFDA) which consequently resulted in the establishment of the Tanzania Medicines and Medical
Devices Authority (TMDA). The guidelines have also been revised to be in line with the
requirements of the quality management system being implemented by the Authority.

I would like to sincerely thank all experts who took part in the revision of the guidelines.
Acknowledgements are particularly extended to Mr. Sunday Kisoma, Dr. Goodluck Gotora, Ms.
Catherine Luanda, Eng. Samwel Hhayuma, Mr. David Mwakyoma, Mr. David Matle, Ms. Jeniva
Jasson and Mr. Jackson Kiberenge.

As some of the guiding principles were adopted /adapted from the guidelines promulgated by the
International Medical Devices Regulators Forum (IMDRF), World Health Organization (WHO),
Health Canada and the United States Food and Drug Administration (US-FDA), gratitude is owed
to these international organizations for making their guidelines accessible.

The positive contributions received from the TMDA Technical Committee for Medical Devices and
Diagnostics Registration and other stakeholders who reviewed the crafted guidelines are also
greatly indebted.

Akida M. Khea
Director of Medical Products Control
Tanzania Medicines and Medical Devices Authority

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 FOREWORD

In vitro diagnostic devices (IVDDs) are subsets of medical devices used to perform tests on human
and other animal samples (e.g. blood, urine, tissue etc). They can detect diseases or other
conditions and help in monitoring the overall health of human beings and other animals.

The second edition of the Guidelines on Submission of Documentation for Registration of In-Vitro
Diagnostic Medical Devices which was approved in May, 2018 provided requirements for
registration of IVDDs used to detect diseases in human and animals. The guidelines also
highlighted details related to requirements for registration of class A IVDDs, Performance
evaluation, robustness studies and inclusion of other tools. The edition had also taken on board
the new definition of medical devices as provided for in the Written Miscellaneous Amendment Act
No. 3 of 2017.

The current edition has no changes with regards to general and technical requirements for
registration of these devices. The edition is a result of Financial Act of 2019 which transformed the
then TFDA to TMDA and to be in line with the requirements of the quality management system
being implemented by the Authority.

It is my expectation that, the applicants will continue to adhere to the requirements outlined in
these guidelines and submit their applications in a more systematic way. This will expedite
assessment of applications and consequently speed-up authorization of IVDDs for marketing in
Tanzania.

Applicants are henceforth advised to read these revised guidelines and submit their applications
based on the requirements as stipulated in this document. Other ISO standards should also be
referred-to when compiling dossiers as articulated in these guidelines. Since requirements
delineated in these guidelines are considered minimal, applicants can submit additional data or
information to substantiate the quality, safety and performance claims provided in their dossiers.

Much as science and technology advances in a super-sonic speed, comments that intend to
improve the current edition are always welcomed from applicants, manufacturers and other users
of this document.

Adam M. Fimbo
Acting Director General
Tanzania Medicines and Medical Devices Authority

INTRODUCTION
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Registration of IVDDs is a legal requirement pursuant to regulation 6 of the Tanzania Medicines and
Medical Devices (Control of Medical Devices) Regulations, 2015. Such process allows for assessment of
data to ascertain the quality, safety and performance of this category of health technologies. IVDDs
are used in many health facilities and hospital settings in Tanzania to diagnose diseases or other
conditions, including determination of the state of health, in order to cure, mitigate, treat or
prevent diseases.

The second edition of the Guidelines on Submission of Documentation for Registration of In-Vitro
Diagnostic Devices, May, 2018 has been reviewed by the Tanzania Medicines and Medical Devices
Authority (TMDA) to be in-line with the Financial Act of 2019 and the requirements of the quality
management system implemented by the Authority.

This third edition is divided into four (4) main sections to include general requirements,
submission requirements, summary technical documentation and labeling requirements. The
sections highlight technical requirements which applicants are required to compile and submit for
assessment by the TMDA.

It is from these details that the Authority will be able to decide on marketing authorization of
IVDDs in Tanzania. The onus is therefore up on the applicants to conduct studies, tests and
investigations, which will provide adequate evidence to allow for registration of their products. It
is henceforth utterly pivotal that applicants read and comprehend the requirements as set- out in
these guidelines to accelerate approval process and increase access to IVDDs in Tanzania.

Availability of IVDDs of acceptable quality, safe and that are effective in performing tests will
improve public health taking into account the fact that some tests are used in laboratory or other
health professional settings and others are used by consumers at home. As part of registration
process, the TMDA will conduct quality audits of manufacturers of IVDDs to verify compliance to
TMDA requirements and ISO standards. Products manufactured at facilities that will not meet
audit requirements, will not be registered by TMDA.

In the course of evaluation of applications, reference will routinely be made to ISO standards and
other internationally accepted guidelines to include those published by World Health Organization
(WHO) and International Medical Device Regulatory Forum (IMDRF) to ensure that IVDDs of good
quality, safe and performing are authorized for marketing. An abridged assessment procedure will
be adopted for IVDDs which have been prequalified by WHO to avoid duplications and hasten
registration of such products.

Applicants should also note that they will now be required to conduct post marketing surveillance
(PMS) of IVDDs in countries that mimic Tanzania conditions to accrue information on their
quality, safety and performance to testify whether they still meet registration requirements post
approval. Such information should be prepared and submitted after every two years (biennial) as
indicated in these guidelines and pursuant to the Tanzania Medicines and Medical Devices (Control of
Medical Devices) Regulations, 2015.

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 DEFINITION OF TERMS

In the context of these guidelines, the following terms shall be defined as follows:

Accessory
An article which is intended specifically by its manufacturer to be used together with a parent
device to enable that device to be used in accordance with its intended use as an IVDD or to
augment or extend the capabilities of the parent device in fulfillment of its intended use as an
IVDD, and therefore should be considered an IVDD.

Act
The Tanzania Medicines and Medical Devices Act, Cap 219.

Analytical performance
Ability of an IVDD to detect or measure a particular analyte.

Applicant
Any person or institution or company that applies formally to get market authorization for IVDD
in Tanzania.

Assay
Investigative (analytic) procedure in laboratory for qualitatively assessing or quantitatively
measuring the presence, amount or functional activity of a target entity (the analyte).

Authority
The Tanzania Medicines and Medical Devices Authority or the acronym “TMDA” established
under section 4(1) of the Act.

Calibrator
Any substance, material or article intended by its manufacturer/ owner to be used in the
calibration of a measuring instrument or measuring system.

Certified Copy
A true copy of the original document certified by a person registered to practice law in the
manufacturer’s country of origin and endorsed with the legal practitioner’s official stamp and
signature.

Clinical Performance
Ability of an IVDD to yield results that are correlated with a particular clinical condition/
physiological state in accordance to target population and intended use.

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Conformity Assessment
The systematic examination of evidence generated and procedures undertaken by the
manufacturer, under requirements established by the Authority, to determine that an IVDD is
safe and performs as intended by the manufacturer and, therefore, conforms to the Essential
Principles of Safety and Performance of Medical Devices.

High Dose Hook Effect

Wrong low measurement of analyte(s) that are present in the specimen in a very high
concentration.

In Vitro Diagnostic Device or its acronym IVDD

A device whether used alone or in combination, intended by the manufacturer for the in vitro
examination of specimens derived from the human body and animals principally to provide
information for diagnostic, monitoring or compatibility purposes. IVDD include reagents,
calibrators, control materials, specimen receptacles, software, and related instruments or
apparatus or other articles and are used for example for the following test purposes: diagnosis,
aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction and determination
of physiological status.

Label
Any written, printed or graphic representation that appears on or is attached to the IVDD or
active ingredient or any part of its packaging, and includes any informational sheet or leaflet
that accompanies the in vitro diagnostics or active ingredient when it is being supplied.

Labeling / information supplied by the manufacturer

A written, printed or graphic matter affixed to an in vitro diagnostic device or any of its
containers or wrappers, or accompanying a medical device, related to identification, technical
description, and use of the device, but excluding shipping documents.

Lay Person
Any individual who does not have formal training in a relevant field or discipline.

Local Responsible Person

A local responsible person is a natural person residing in Tanzania or cooperate body registered
in Tanzania who has received a mandate from the applicant to act on his behalf with regard to
matters pertaining to registration of devices in Tanzania.

Manufacture
To make, fabricate, produce or process an IVDD and includes:
a. any process carried out in the course of so making, fabricating, producing or processing
the in vitro diagnostic devices; and

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 b. packaging and labeling of IVDD before it is supplied.

Manufacturer
Any person or a firm that is engaged in the manufacture of IVDD.

Medical Device(s)
Any instrument, apparatus, laboratory equipment and reagents, implement, machine,
appliance, implant, in vitro reagent or calibrator, software, material or other similar or related
article which:

a. is intended by manufacturer to be used, alone or in combination for human beings or

other animals for one more of the specific purpose(s) of-

(i) diagnosis, prevention, monitoring, treatment or alleviation of diseases or

compensation for an injury;
(ii) investigation, replacement, modification or support or the anatomy or of a
physiological process;
(iii) supporting or sustaining life;
(iv) control of conception;
(v) disinfection of medical devices;
(vi) providing information for medical or diagnostic purposes by means of in vitro
examination or specimens derived from the human body or other animal; and

b. does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
intended function by such means.

National Standard
A standard as prescribed by the Tanzania Bureau of Standards.

Near Patient Testing

Any testing performed outside the laboratory environment by qualified personnel, generally
near to or at the side of the patient, also known as Point-of-Care Testing (POCT).

Objective Evidence
Information that can be proved true, based on facts obtained through observation,
measurement, testing or other means.

Performance Evaluation
Assessment and analysis of data to establish or verify the performance (analytical performance
and where applicable, clinical performance) of an IVDD.

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Process Validation
Confirmation by objective evidence that a process consistently produces a result or product
meeting its pre-determined requirements.

Quality Audit
The process of systematic examination of a quality system of IVDDs manufacturing facilities
carried out by the Authority to demonstrate conformity for regulatory purposes.

Quality System
An aggregate of the organizational structure, incentives, plans, policies, responsibilities,
procedures, processes resources and infrastructure required in formulating and implementing
quality management and achieving its objectives.

Quality Management System

Collection of business processes aim to direct and control an organization with regard to
quality, from establishing quality policy, quality objectives and implementing and maintaining
quality system.

Reagent
Any chemical, biological or immunological component, solution or preparation intended by the
manufacturer to be used as IVDD.

Recall
Any action taken by its manufacturer, importer, supplier or registrant to remove the medical
device from the market or to retrieve the medical device from any person to whom it has been
supplied, because the medical device may:

a. be hazardous to health;
b. fail to conform to any claim made by its manufacturer or importer relating to its quality,
safety or performance.

Recognized Standards
National or international standards deemed to offer the presumption of conformity to specific
Essential Principles of Safety and Performance.

Registrant
The person who applied for and obtained the registration of the medical devices including IVDD
under the medical device regulations.

Risk
Combination of the probability of occurrence of harm and the severity of that harm.

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Self-testing
Means testing performed by oneself.

Specimen receptacles
Means devices, whether vacuum-type or not, specifically intended by their manufacturers for
the primary containment and preservation of specimens derived from the human body and
other animals for the purpose of IVDD examination.

Technical Documentation
Means documented evidence, normally an output of the Quality Management System that
demonstrates compliance of a device to the Essential Principles of Safety and Performance of
IVDD.

Validation
Means confirmation by examination and provision of objective evidence that the requirements
for a specific intended use have been fulfilled.

Verification
Means confirmation by examination and provision of objective evidence that the specified
requirements have been fulfilled.

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1.0 GENERAL REQUIREMENTS

1.1 Applicant

a) An application for registration of in vitro diagnostic device (IVDD) can be made by a

manufacturer or by a person who orders the IVDD to be manufactured for sale in Tanzania.

b) The applicant shall be responsible for the product, information supplied in support of the
application for registration and variations thereof.

c) An applicant who is not a resident in Tanzania shall nominate a Local Responsible Person
(LRP). A certified copy of power of attorney, formal agreement or any other official
authorization shall be submitted by an applicant as official proof of nomination of a LRP.

1.2 Local responsible person

The Local responsible person (LRP) shall:

a) Monitor the device on the market and inform the Authority immediately after the detection
of any problem relating to a registered device such as serious manufacturing defects which
may endanger public health.

b) Facilitate communication between the Applicant and the Authority on matters relating to
the product.

c) Handle device recalls implementation.

d) Provide technical support and services to users of registered device(s).

1.3 Classification of IVDD

a) The classification of an IVDD is based on the following criteria:

(i) The intended use and indications for use as specified by the manufacturer (specific
disorder, condition or risk factor for which the test is intended),

(ii) The technical/scientific/medical expertise of the intended user (lay person or

professional),

(iii) The importance of the information to the diagnosis (sole determinant or one of
several), taking into consideration the natural history of the disease or disorder
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 including presenting signs and symptoms which may guide a physician/veterinarian,

(iv) The impact of the result (true or false) to the individual and/or to public health.

b) IVDD should be classified into one of the four (4) classes of devices A, B, C or D as
described below:

CLASS RISK LEVEL EXAMPLES

Low Individual Risk and Low Specimen receptacles,
A Public Health Risk Selective/differential microbiological
media, identification kits for cultured
microorganisms, wash solutions,
instruments and plain urine cup.

B Moderate Individual Risk Vitamin B12 level test, Pregnancy Self

and/or Low Public Health Testing, Anti-Nuclear Antibody, and
Risk Urine Test Strips.
C High Individual Risk and/or Blood Glucose Test, Human Leukocyte
Moderate Public Health Risk Antigen (HLA) Test, Prostate Specific
Antigen (PSA) Screening, Rubella
Antibodies Test.
D High Individual Risk and HIV Blood Donor Screening, HIV
High Public Health Risk Diagnostic Test.

c) Classification should be done based on classification rules appended as Annex I of these

guidelines.

d) If more than one classification rule is applicable to the device, the rules resulting to the
highest risk classification shall be applicable to the device. However, the Authority reserves
the right to decide on the class of the device.

1.3.1 Accessories

Where applicable, the following considerations should apply:

a) Calibrators intended to be used with an in vitro diagnostic reagent should be placed in the
same class as the in vitro diagnostic reagent.
b) Stand alone control materials with no assigned values intended for use with multiple or
single analyte(s) should not be placed in the same class as the in vitro diagnostic reagent(s).

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 c) Stand alone control materials with quantitative or qualitative assigned values intended for
one specific analyte or multiple analyte(s) should be placed in the same class as the in vitro
diagnostic reagent(s).

1.3.2 Software

While most software are incorporated into the IVDD itself, some are not. Provided that such stand
alone software falls within the scope of the definition for an IVDD it should be classified as
follows:

a) Where it controls or influences the intended output of a separate IVDD, it will have the
same class as the device itself.

b) Where it is not incorporated in an IVDD, it is classified in its own right using the
classification rules.

1.4 First time application

a) A separate and complete product dossier in both hard copy and electronic forms, in both
PDF and MS WORD formats is required for each IVDD being sent for registration.

b) Applications shall be accompanied by the following:

(i) A non-refundable evaluation fee as provided for in the Fees and Charges Regulations
in force.

(ii) One commercial pack sample of the device or artwork where applicable, at the time of
lodging an application for registration.

1.5 Documentation

1.5.1 Language

All applications and supporting documents shall be made in Kiswahili or English.

1.5.2 Requirements for Class A IVDDs

a) Class A IVDDs are divided in two (2) categories; Class A IVDDs supplied in non- sterile
state, non-active and non-measuring function and Class A IVDDs supplied in sterile, active
and have measuring function.
b) The submission requirements for each category of Class A IVDDs shall be as stipulated in
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 section 2.1 of these guidelines.

1.5.3 Requirements for Class B, C and D IVDDs

The submission requirements for Class B, C and D IVDDs shall be as stipulated in Section 2.2 of
these guidelines.

1.5.4 Paper type and binding

a) Data shall be presented on A4 and 80g/m2 paper with readily readable letters of at least 12
font sizes. Every page shall be numbered sequentially. Extension sheets, tables, diagrams
and other supporting documents shall as far as possible be of the same size, well annotated,
numbered and appropriately cross- referenced.

b) All parts must be bound separately and arranged sequentially in spring file covers with
flexible seat. Lever arch files are not permissible. One or more spring file covers may be
used depending on the number of pages contained in a part. The file cover should be made
of hard, non-collapsible biodegradable material. The thickness should be expandable or
reducible depending on the total thickness of the contents.

1.6 Payment of fees, screening and processing of applications

1.6.1 Payment of fees

a) Every application shall be accompanied by appropriate fees as specified in the Fees and
Charges Regulations in force at the time of application. All fees are payable at the time of
lodging an application. The fees may be paid directly to TMDA or by bank transfer to:-

Tanzania Medicines and Medical Devices Authority, Account Details.:

i) NMB Bank, University Branch, Account Name: GEPG TMDA USD –

COLLECTION ACCOUNT, Account number: 20810015291, Swift Code:
NMIBTZTZ

ii) NBC Bank, UDSM Branch, Account Name: GEPG TMDA USD-
COLLECTION ACCOUNT, Account number: 040105002468, Swift Code:
NLCBTZTZ

iii) CRDB Bank, Holland House Branch, Account Name: GEPG CRDB USD
REVENUE ACCOUNT, Account number: 0250021399100, Swift Code:
CORUTZTZ

All payments shall be made against control number indicated on the Invoice
generated against the application.

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 b) When payment is made by bank transfer all bank charges shall be borne by the applicant
who shall also make sure that advice note is submitted to TMDA giving details of the
payment in particular the name of the applicant, the device or devices paid for and amount
of fees paid.
c) Fees are non-refundable once paid to the Authority.

d) For each registered device an annual retention fees shall be paid on or before the end of
January of each year for which the fees are due to maintain a medical device on the medical
device register. The registration number of the device must be quoted at the time of
payment.

e) The amount of retention fee to be paid shall be as prescribed in the Fees and Charges
Regulations in force at the time of application.

1.6.2 Processing of applications

a) Once an application has been accepted and evaluation fees paid the processing of
application will be as provided for in the current Client’s Service Charter. This will involve
assessment of applications, request for additional data/samples and clarification of some
issues, where applicable.

b) Once a query or a request has been raised, the processing shall halt until after the response
to the query has been received. If no response to the query or request has been received
within six months the application will be rejected.

1.6.3 Performance evaluation

a) After assessment of submitted technical documents (dossier), the Authority may conduct or
may direct the applicant to conduct laboratory analysis and performance evaluation of the
respective IVDD using the established protocols.

b) Cost for laboratory analysis and performance evaluation will be borne by the applicant as
provided for by the selected laboratory or as prescribed in the Fees and Charges
Regulations in force.

1.7 Registration of the device

a) When an IVDD is found to have complied with all the prescribed registration
requirements, the applicant will be informed to that effect.

b) A certificate of registration together with such conditions as Authority may determine shall
be issued.
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1.7.1 Validity of registration

The registration of an IVDD shall be valid for five (5) years unless suspended or revoked by the
Authority or terminated by the Registrant. The validity of registration shall be subject to:-

a) Payment of annual retention fees as prescribed in the Fees and Charges Regulations in
force.

b) Submission of biennial post-marketing surveillance report(s) in the format appended as

Annex II.

c) Submission of adverse effects reports associated with the use of device.

1.7.2 Termination of registration

a) The Authority may, by giving reasons in writing, suspend or revoke the registration of a
device, or amend the conditions of its registration.

b) The Registrant may, by giving 60 days written notice and reasons to the Authority,
terminate the registration of a device.

1.8 Application for variation of a registered device

a) The Authority should be informed on any anticipated significant change(s) that could
reasonably be expected to affect the safety or effectiveness of an IVDD. Significant
change(s) will include any of the following:

(i) The manufacturing process, facility or equipment;

(ii) The manufacturing quality control procedures, including the methods, tests or
procedures used to control the quality, purity and sterility of the device or of the
materials used in its manufacture;

(iii) The design of the device, including its performance characteristics, principles of
operation and specifications of materials, energy source, software or accessories; and

(iv) The intended use of the device, including any new or extended use, any addition or
deletion of a contraindication for the device and any change to the period used to
establish its expiry date.

b) These changes will require TMDA approval before they can be implemented. Any other
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 change(s) should be notified immediately to the Authority and may be implemented
without prior approval.

c) All applications for variation to a registered device shall be made by submitting a duly
filled in form appended as Annex III and shall be accompanied by variation fee as
prescribed in the Fees and Charges Regulations in force at the time of application.

1.9 Applications for renewal of registration

a) Applications for renewal of registration shall be made at least 90 days prior to the expiry
date of registration of the device.

b) The application shall include submission of filled in application form appended as Annex
IV, information pertaining to changes that were made to a registered device (if any) and
application fee as prescribed in the Fees and Charges Regulations in force.

1.10 Compilation of the dossier

a) Applicants are required to arrange the application dossier in the format described below:

(i) The application form (Annex V of these guidelines)

(ii) Device details (Section 2 of these guidelines)

(iii) Summary technical documentation (Section 3 of the guidelines)

(iv) Labeling information (Section 4 of the guidelines)

(v) Essential requirements checklist (Annex VI of these guidelines)

b) Failure to arrange the application dossier accordingly will lead to rejection of the
application.

1.11 Evidence of compliance to Quality Management System

a) For the IVDDs with higher risks the pre-registration quality audit will be conducted to
verify their compliance with requirements. The audit will be conducted on risk basis.

b) For IVDDs that require evidence of compliance to Quality Management System, a CE

certificate issued by a Notified Body designated in Europe for the purposes of the In Vitro
Diagnostic Medical Devices Directive (98/79/EC) and issued under Annex IV Section 3 or

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 Annex VII of the Directive will be accepted (may also be referred to as an EU Certificate, an
EC certificate or an EEC Certificate). ISO 13485 certificates issued by Notified Bodies
designated in Europe for the purposes of the IVDD will also be accepted.

1.12 Appeals

a) Any person aggrieved by a decision of the Authority in relation to any application for
registration of an IVDD may make representations in writing to TMDA.

b) If after consideration of the representations, the Authority is satisfied it may approve

registration of an IVDD and if not satisfied it shall reject the application. In case the
applicant is not satisfied with the decision, may appeal to the Minister responsible for
Health. The Minister’s decision shall be final. If the Registrant would not be satisfied by the
Minister’s decision, he may appeal to the Court of Law.

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2.0 SUBMISSION REQUIREMENTS

2.1 Submission requirements for Class A IVDDs

a) Class A IVDDs supplied in non-sterile state, non-active and non-measuring function are
exempted from registration but must be notified to the Authority. Applicants shall
submit duly filled in notification form through the TMDA online portal system in the
format appended as Annex VII.

b) Class A IVDDs supplied in sterile, active and have measuring function are required to
be registered by the Authority. Applicants shall be required to submit the following
information:

(i) Dully filled in application (Annex V).

(ii) Copies (in English and in original colour) of the labels on the IVDDs and its
packaging in primary and secondary levels of packaging. Labels must be provided
for all the components of IVDD system, members of IVDD family and accessories
submitted for registration. Alternatively, a representative label may be submitted
for variants, provided the variable fields on the artwork are annotated, and the
range of values for the variable fields are indicated.

(iii) The instructions for use.

(iv) The patient information leaflet.

(v) The promotional material (including brochures and catalogues.

(vi) For sterile IVDD, a report on validation of the sterilization method.

(vii) For an IVDD with measuring function, certification on IVDDs metrology or

equivalent.

(viii) For active IVDD, certification to electrical safety standards e.g. IEC 60601.

(ix) For an IVDD containing materials of animal, human, microbial and/or

recombinant origin, the following information must be submitted in addition to the
information above:

• A list of all materials of animal, human, microbial and/or recombinant origin

used in the IVDDs and in the manufacturing process of the IVDDs. This
includes, but not limited to animal or human cells, tissues and/or
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 derivatives, and cells, tissues and/or derivatives of microbial or recombinant
origin; and
• Identity of immediate sources of the above.

2.2 Submission requirements for Class B, C and D IVDDs

a) Applicants are required to submit the following information:

(i) A dully filled in application form (Annex V).

(ii) Device details as described below:

• Name(s) - State the brand and generic name of the IVDD.

• Description - Provide general information on design, characteristics and
performance of the IVDD. The description should also include information
on device packaging.
• Category - State the class of the IVDD and the applicable classification rule as
appended in Annex I of these guidelines.
• Intended Use/Indication - State the intended use of the IVDD and/or
provide a general description of the disease or condition that the device will
diagnose, treat, prevent, or mitigate.
• Instructions of Use - Give a concise summary of information for safe use of
the device including procedures, methods, frequency, duration, quantity and
preparation to be followed.
• Contraindications - State conditions under which the IVDD should not be
used. For example, a limitation of an assay using specimens from patients
who have received preparations of mouse monoclonal antibodies for therapy
when tested with assay kits which employed mouse monoclonal antibodies.
It may show either false elevated or depressed values.
• Warnings - State the specific hazard alert information that a user needs to
know before using the IVDD. E.g. for products containing biological material,
radioactive material, explosive material and any other hazardous material,
safety warnings must be included.
• Precautions - State briefly precautions to be taken and any special care
necessary for the safe and effective use of the IVDD.
• Adverse Effects - Describe all adverse and side effects associated with the
IVDD under normal conditions of use.
• Alternative Use - Describe any alternative practices or procedures for
diagnosing, treating, or mitigating the disease or condition for which the
IVDD is intended.
• Storage conditions - State the storage conditions for the IVDD.
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 • Recommended shelf-life (where applicable) - State the
recommended shelf-life of the IVDD.

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3.0 SUMMARY TECHNICAL DOCUMENTATION

3.1 Device description and features

Provide a detailed description of the device attributes that are necessary to explain how the device
functions. These details should include:

a) Intended use of the IVDD. This may include:

(i) What is detected;

(ii) The function (e.g. screening, monitoring, diagnostic or aid to diagnosis, staging or aid
to staging of disease);

(iii) The specific disorder, condition or risk factor of interest that is intended to detect,
define or differentiate;

(iv) Whether the product is automated or not;

(v) Whether the test is qualitative or quantitative;

(vi) The type of specimen(s) required (e.g. serum, plasma, w h o l e blood,

cerebrospinal fluid (CSF), sputum, urine);

(vii) The intended testing population (e.g. neonates, antenatal women);

(viii) If applicable the environmental condition during operation (temperature range and
attitude).

b) The intended user (laboratory professional and/or at point-of-care).

c) A general description of the principle of the assay method or instrument principles of

operation.

d) A description of the components of the assay (e.g. reagents, assay controls and calibrators),
and where appropriate, a description of the reactive ingredients of relevant components
(such as antibodies, antigens and nucleic acid primers).

e) A description of the specimen collection and transport materials provided with the product
or description of specifications recommended for use.

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 f) For instruments of automated assays: a description of the appropriate assay characteristics
or dedicated assays.

g) For automated assays: a description of the appropriate instrumentation characteristics or

dedicated instrumentation.

h) If applicable, a description of any software to be used with the device.

i) If applicable, a description or complete list of the various configurations/variants of

devices that will be made available. For example, a family of pregnancy rapid test can
consist of device available in different configurations, such as test strip or in a cassette.

j) If applicable, a description of the accessories, and other non- IVDD products that are
intended to be used in combination with the diagnostic.

k) Risk class and the applicable classification rule for the IVDD according to these guidelines.

The instruction for use may be used to provide some of this information on the condition that a
cross-reference to the different requirements is supplied in conjunction with the instructions-for-
use.

3.2 Evidence of conformity to Essential Principles

Provide evidence of conformity to Essential Principles of Safety and Performance (EPSP) by

completing the checklist appended as Annex VI.

a) Manufacturer should identify the essential principles of safety and performance that are
applicable to the device and the general methods used to demonstrate conformity to each
applicable Essential Principle. The methods that may be used include:

(i) Conformity with a recognized or other standard(s)

(ii) Conformity with a commonly accepted industrial test method (reference method)

(iii) Conformity with appropriate in-house test methods that have been validated and
verified;

(iv) Comparison to a diagnostic already available on the market.

b) When the manufacturer uses national, international or other standards to demonstrate

conformity with the Essential Principles, full title of the standard, identifying numbers,
date of the standard and the organization that created the standard should be provided.
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 c) The IVDD, to which the Essential Principles (EP) conformity checklist is applicable,
should be identified by the brand name, common name and risk class on the checklist
itself. The columns of the checklist should be completed as follows:

(i) Applicable to the IVDD?

Either a “Yes” or “No” answer is required. If the answer is “No” there should be a
brief explanation.

(ii) Method of conformity

State the title and reference of the standard(s), industry or in-house test method(s),
comparison study(ies) or other methods to demonstrate compliance. For standards,
this should include the date of the standard and where a standard is referred to
more than once in the checklist, the reference number and date can be repeated.

(iii) Identity of specific documents

The column should contain the reference to the actual technical documentation
that demonstrates compliance to the essential principle, i.e. the certificate
number(s), test reports, study reports or other documents that resulted from the
method used to demonstrate compliance, and its location within the technical
documentation or dossier.

3.3 Risk analysis

Provide a summary of the risks identified during the risk analysis process and how such
risks have been controlled to an acceptable level. Preferably, the risk analysis should be
based on recognized standards and be part of the manufacturer’s risk management plan.

The summary should address possible hazards for the IVDD such as the risk from false
positive or false negative results, indirect risks which may lead to erroneous results, or
from user-related hazards, such as reagents containing infectious agents. The results of
the risk analysis should provide a conclusion with evidence that remaining risks are
acceptable when compared to the benefits.

3.4 Design and manufacturing information

3.4.1 Product design

Provide information such as to give a general understanding of the design applied to the IVDD.
It should include a description of the critical ingredients of an assay such as antibodies,
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antigens, enzymes and nucleic acid primers provided or recommended for use with the IVDD:

a) For instruments include a description of major subsystems, analytical technology (e.g.

operating principles, control mechanisms), dedicated computer hardware and software.

b) For instruments and software, give an overview of the entire system, including an
Architecture Design Chart, which is typically a flowchart of the relationships among the
major functional units in the software, including relationships to hardware and to data
flows such as networking.

c) For standalone software, include a description of the data interpretation methodology

(i.e. algorithms).

d) For self-testing devices the design should include a description of the design aspects that
make it suitable for lay person use.

e) If design takes place at multiple sites, a controlling site must be identified.

3.4.2 Formulation and composition

Provide formulation/composition for each of the ingredients:

3.4.2.1 Materials

Provide complete details of material specifications, including raw materials;

a) All components of the IVDD should be listed and chemically and biologically
characterized, including antibodies, antigens, and assay controls, substrates used to
detect antigen-antibody complexes, and test reagents. Appropriate references should be
cited.

b) If synthetic peptides are used, the peptide sequence should be provided.

c) If components are of biological origin or recombinant, the source must be indicated and
details on production must be provided. These details would include the strain of the
virus, the cell line for cultivation of the virus,

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 sequences of relevant nucleic acids and amino acids, etc., used in the manufacturing
process of viral lysate, purified proteins, recombinant and synthetic proteins.

d) If applicable, process validation results to be provided to substantiate that

manufacturing procedures are in place to minimize biological risks, in particular, with
regard to viruses and other transmissible agents. This also includes inactivation of
infectious organisms in reagents and the production of reagents.

e) If applicable, information to be provided on irradiating components, non- ionizing or

ionizing (e.g. Iodide- 131 in the Radioimmunoassay kit, radio-labeled Phosphorus-32
DNA probes in Southern blots).

f) If applicable, information should be provided on the poison or controlled substance e.g.

Buprenorphine in drug assay kit).

g) Give the nature and specification of the packaging material(s) including complete
chemical and physical characterization of the packaging material making either direct or
indirect contact with the IVDD.

h) Identify the sources of the materials from which the components are constructed.

3.4.2.2 Biological safety

List all biological components included in the IVDD to include material of bacterial, viral,
parasitic, animal, or human origin or their derivatives where applicable. Indicate the name of
the biological component, details of its use in the product and description of steps taken for the
reduction of transmission or infection risk.

3.4.2.3 Documentation of design change

Provide records of each design change, if any, with reasons for these changes along with
associated validation/verification data. Include evidence that the change achieves the desired
effect, and that the product continues to comply with the Essential Principles of Safety and
Performance.

3.4.3 Manufacturing processes

3.4.3.1 Overview of manufacturing process

Provide information on the manufacturing process, which may be in form of a process flow
chart, showing an overview of production including technologies used, assembly

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and packaging of the finished IVDD. Include details of any in-process and final product testing
(e.g. the manufacturer’s QC release program).

3.4.3.2 Sites of manufacture

Provide the following information;

a) Name of site,

b) Physical address of the site,

c) Description of the component manufacture/stage of manufacturing process carried out

at the site,

d) A simple sight plan highlighting production areas and number of employees at the site,

e) A description of any other manufacturing that occurs at the site;

For all the critical manufacturing sites that are involved in the manufacture of this product (i.e.
including design, warehousing and quality control stages of manufacture)

3.4.3.3 Key suppliers

Provide a list of key suppliers of ingredients/products/services for the manufacture of the

IVDD, indicating the;

a) Name of the supplier,

b) Supplier’s manufacturing site physical address,

c) A description of the ingredient/product/service supplied,

d) Evidence of purchasing and verification procedures for the

ingredients/products/services sourced from these suppliers.

3.5 Device Specifications

a) Describe functional characteristics and technical performance specifications for the

device including as relevant, accuracy, sensitivity, specificity of measuring and other
specifications including chemical, physical, mechanical, electrical and biological.

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 b) A list of the features, dimensions and performance characteristics of the IVDD its variants
and accessories should be provided in the dossier and also made available to the end user.

3.5.1 Device validation and verification

Summarize the results of validation and verification studies undertaken to demonstrate

compliance of the IVDD with Essential Principles that apply to it. Whenever applicable the
information should cover:-

a) The complete study protocol,

b) The method of data analysis,

c) Complete study report,

d) The study conclusion,

e) Any published literature regarding the device or substantially similar devices.

f) Summaries or reports of tests and evaluations based on other standards, manufacturer

methods and tests or alternative ways of demonstrating compliance.
Declarations/certificate of compliance to a recognized standard as applied by the
manufacturer should be provided.

When a recognized standard exists that contains the protocol and the method of data analysis,
this information can be substituted by a declaration/certificate of conformity to the recognized
standard. However, a summary of the data and conclusions should be provided. Where
appropriate actual test results summaries with their acceptance criteria should be provided and
not just pass/fail statements.

3.5.2 Specimen type

This section should describe the different specimen types that can be used, including their
stability (and storage) conditions and is typically applicable to all systems and assay types.

a) Stability includes storage and where applicable transport conditions. Storage includes
elements such as duration, temperature limits and freeze/thaw cycles.

b) Summary information for each matrix and anticoagulant when applicable, including a
description of the measurement procedure for comparison or determination of
measurement accuracy. This includes information such as specimen type tested,
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 number of samples, sample range (using spiked samples as appropriate) or target
concentrations tested, calculations and statistical methods, results and conclusions.

3.6 Analytical performance characteristics

3.6.1 Accuracy of measurement

Provide information to describe both trueness and precision studies.

3.6.1.1 Trueness of measurement

Provide information on the trueness of the measurement procedure and summarize the data
used to establish the trueness measures for both quantitative and qualitative assays.

3.6.1.2 Precision of measurement

Provide information to describe repeatability and reproducibility studies.

a) Repeatability

Provide details on repeatability estimation and information about the studies used to
estimate, as appropriate, within-run variability. Repeatability data is obtained for
instrumentation in conjunction with an appropriate assay.

For products to be used at point-of-care, where the testing may be undertaken by non-
laboratory trained personnel (for example, clinic nurses), repeatability should be
established in two steps, first, with professional laboratory personnel to establish the
optimal repeatability of the IVDD under controlled laboratory conditions then followed
by a consumer field evaluation to determine the product’s performance when used by
non-laboratory trained personnel, unassisted, following instructions provided with the
product.

b) Reproducibility

Provide information on reproducibility estimates and information about the studies

used to estimate, as appropriate, variability between days, runs, sites, lots, operators and
instruments. Such variability is also known as “Intermediate Precision”.

For products to be used at point-of-care, where the testing may be undertaken by non-
laboratory trained personnel (for example, clinic nurses),

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 reproducibility should be established in two steps, first, with professional laboratory
personnel to establish the optimal reproducibility of the IVDD under controlled
laboratory conditions then followed by a consumer field evaluation to determine the
product’s performance when used by non-laboratory trained personnel, unassisted,
following instructions provided with the product.

3.6.2 Analytical sensitivity

Provide information about the study design and results. Give a detailed description of specimen
type and preparation including matrix, analyte (measured) levels, and how levels were
established. The number of replicates tested at each concentration should also be provided as
well as a description of the calculation used to determine assay sensitivity. For example:

a) Number of standard deviations above the mean value of the sample without analyte
(measurand), commonly referred to as ‘Limit of Blank’ (LoB).

b) Lowest concentration distinguishable from zero, based on measurements of samples

containing analyte (measurand), commonly referred to as ‘Limit of Detection (LoD).

c) Lowest concentration at which precision and/or trueness are within specified criteria,
commonly referred to as ‘Limit of Quantitation’ (LoQ).

3.6.3 Analytical specificity

a) Give information to describe interference and cross reactivity studies to determine the
analytical specificity, defined as the ability of a measurement procedure to detect or
measure only the analyte (measurand) to be detected, in the presence of other
substances/agents in the sample.

b) Provide information on the evaluation of potentially interfering and cross reacting

substances/agents on the assay. Information should be provided on the
substance/agent type and concentration tested, sample type, analyte (measurand) test
concentration, and results.

c) Interferents and cross reacting substances/agents, which vary greatly depending on the
assay type and design, could derive from exogenous or endogenous sources such as:
Substances used for patient treatment (e.g. therapeutic drugs, alcohol, vitamins, foods,
etc.), substances added during sample preparation (e.g. preservatives, stabilizers),
substances encountered in specific specimen types (e.g. haemoglobin, lipids, bilirubin,
proteins), and;

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 analytes of similar structure (e.g. precursors, metabolites) or medical conditions
unrelated to the test condition including specimens negative for the assay but positive
for a condition that may mimic the test condition (e.g. for a hepatitis A assay: test
specimens negative for hepatitis A virus, but positive for hepatitis B virus)

3.6.4 Metrological traceability of calibrator and control material values

Where applicable, summarize the information about metrological traceability of values assigned
to calibrators and trueness control materials. Include, for reference materials and/or reference
measurement procedures and a description of value assignment and validation.

3.6.4.1 Measuring range of the assay

Provide a summary of studies, which define the measuring range (linear and non- linear
measuring systems) including the limit of detection and describe information on how these
were established. The summary should include a description of specimen type, number of
samples, number of replicates, and preparation including information on matrix, analyte
(measurand) levels and how levels were established. If applicable, add a description of high
dose hook effect and the data supporting the mitigation (e.g. dilution) steps.

3.6.4.2 Validation of assay cut-off

Provide a summary of analytical data with a description of the study design including methods
for determining the assay cut-off, including: the population (s) studied, method or mode of
characterization of specimens and statistical methods e.g. Receiver Operator Characteristic
(ROC) to generate results and if applicable, define gray- zone/equivocal zone.

3.6.4.3 Validation of assay procedure – reading time

Provide information on how the reading time (either end point or reading window) claimed in
the Instructions for Use was determined.

3.7 Stability (excluding specimen stability)

Describe claimed shelf life, in use stability and shipping studies.

3.7.1 Claimed shelf life

Provide information on stability testing studies, to support the claimed shelf life, performed on
at least three different lots manufactured under conditions that are essentially equivalent to
routine production conditions (these lots do not need to be consecutive lots). The summary
should include:
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 a) The study report (i.e. protocol, number of lots, acceptance criteria and testing intervals),

b) When accelerated studies have been performed in anticipation of the real time studies,
identify the method used for accelerated studies;

c) Conclusion and claimed shelf life.

Note: Shelf life can be derived from the lot with the longest real time stability data as long as
accelerated or extrapolated data from all three lots are comparable.

3.7.2 In use stability

Provide information on in use stability studies for one lot reflecting actual routine use of the
device (real or simulated). This may include open vial stability and/or, for automated
instruments, on board stability.

In case of automated instrumentation if calibration stability is claimed, supporting data should

be included sufficient to describe: the study protocol (i.e. protocol, acceptance criteria and
testing intervals), conclusions and claimed in use stability.

3.7.3 Shipping stability

Provide information on shipping stability studies for one lot to evaluate the tolerance of
products to the anticipated shipping conditions, describing the study report( i.e. protocol,
acceptance criteria), method used for simulated conditions, conclusion and recommended
shipping conditions.

Shipping studies can be done under real and/or simulated conditions and should include
variable shipping conditions such as extreme heat and/or cold.

3.7.4 Robustness studies

Provide information to demonstrate that the product design is robust e.g. insensitive to
environmental and usage variation. Robustness (flex) studies are designed to challenge the
system under conditions of stress to identify potential device deficiencies, including failures,
and determine the robustness of the product.

The manufacturer must consider multiple skill levels of users, as well as potential instrument
and reagent problems. Below is a list of factors that may need to be considered when
performing robustness studies:

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a) Operator error/ human factors, including not limited to;
(i) Use of incorrect specimen type,
(ii) Incorrect application of the specimen to the device (e.g., incorrect placement,
incorrect volume),
(iii) Incorrect handling of reagents including those in self- contained unitized test
devices, incorrect placement of device (e.g., non-level surface),
(iv) Incorrect placement of reagents, including strips, or other components that contain
reagent, use of incorrect reagents (for example, reagents that are not specific for the
particular device or lot or generic reagents),
(v) Incorrect order of reagent application, use of incorrect amount of reagent, incorrect
timing of procedures (e.g., specimen application, running the test, or reading
results),
(vi) Incorrect reading of test results, incorrect reading due to color blindness etc

b) Specimen integrity and handling including errors in specimen collection, use of

inappropriate anticoagulant, clotted specimens, error in specimen handling, incorrect
specimen transport and/or storage, presence of interfering substances, presence of
bubbles in the specimen etc.

c) Reagent integrity (Reagent viability) including use of improperly stored reagents, use of
outdated reagents, use of improperly mixed reagents, use of contaminated reagents etc

d) Hardware, software, and electronics integrity including power failure, power

fluctuation, incorrect voltage, repeated plugging and unplugging of the device,
hardware failure, software failure, electronic failure, physical trauma to unit etc.

e) Stability of calibration and internal controls including factors that affect calibrator and
calibration stability, factors that may interfere with calibration

f) Environmental factors including impact of key environmental factors (heat, humidity,

barometric pressure changes, altitude (if applicable), sunlight, surface angle, device
movement, etc.) on reagents, specimens, and test results, impact of key environmental
factors (including changes in parameters such as pH or temperature) etc. The following
should be provided:

(i) A summary of the evidence that falls within this category,

(ii) State the test environment and relation to the intended use environment,
(iii) A discussion of what tests were considered for the device and why they were or
were not performed,
(iv) A discussion to demonstrate why the evidence presented is sufficient to support
the application,

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 (v) If a performance study has been conducted that includes human factors/usability
end points, reference to the studies and endpoints should be made, but full results
do not need to be repeated.

3.8 Software verification and validation (if applicable)

Provide information on the software design and development process and evidence of the
validation of the software, as used in the finished device. This information should typically
include the summary results of all verification, validation protocol and report and testing
performed both in-house and in a simulated or actual user environment prior to final release. It
should also address all of the different hardware configurations and, where applicable,
operating systems identified in the labeling.

3.9 Clinical performance

Provide evidence of assessment and analysis of data generated from the clinical use of the
product sufficient enough to verify the clinical safety of the IVDD. Include claims for
clinical/diagnostic sensitivity and specificity. All claims should be supported by well-designed
performance evaluations which should include:

a) A detailed written plan and protocol of the evaluation study

b) Dates on which the study was performed and by which site

c) A written report on the outcome of the study; all anomalous results should be explained
and justified. The report outline should contain,

(i) The technology on which the medical device is based, the intended use of the
device and any claims made about the device’s clinical performance or safety.

(ii) The nature and extent of the clinical data that has been evaluated; and,

(iii) How the referenced information (recognized standards and/or clinical data)
demonstrate the clinical performance and safety of the device in question.

d) Details of the IVDD lots/batches used for the evaluation including lot number date of
expiry, and the storage conditions of the product prior to and during study.

e) The clinical evaluation report should be signed and dated by evaluator(s) and
accompanied by manufacturer’s justification of the choice of evaluator.

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f) The clinical evaluation report should be summarized as per required
information elaborated above.

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4.0 LABELLING REQUIREMENTS

a) The product dossier should contain a complete set of labeling associated with the product.
This includes:

(i) Labels
(ii) Instructions for use (IFU)
(iii) If applicable, the instrument manual
(iv) Any other instructional materials provided to the user

b) Labeling information shall be in English and/or Kiswahili and shall be expressed in a

legible, permanent and prominent manner (engraved or embossed) that can be easily
understood by the intended user.

4.1 Labels

a) Include copies of all packaging labels for the assay. This includes: outer labels and
component labels.

b) Labels must minimally include the following information:

(i) Product name and product identification number (product code/catalogue number),
(ii) Name of manufacturing site and physical address,
(iii) Contents and if the contents are not readily apparent, an indication of what the
package contains, expressed in terms appropriate to the device such as size, net
weight, length, volume or number of units, volume after reconstitution shall be
indicated,
(iv) Manufacturing and expiry dates shall be indicated where applicable and shall follow
the requirements of ISO 8601,
(v) Storage conditions necessary to maintain the stability of the reagents, calibrators,
control materials in the unopened state and other IVDD shall be indicated. If there are
any other conditions that may affect the handling or storage of the reagents,
calibrators, control materials and other IVDD shall be specified e.g. fragile,
(vi) Warning and precautions: If an IVDD is considered hazardous, the outer container
label shall include the appropriate danger wording or symbol(s)
e.g. chemical, radioactive and biological hazards,
(vii) Lot/batch and/or serial number,
(viii) The words “Sterile” if the manufacturer intends to sell the IVDD in a sterile condition,
(ix) Names of all included reagents in each box on the outer package label, where
possible,

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 (x) The word “For Single Use Only” shall be included if the IVDD is intended for
single use,
(xi) The In vitro diagnostics use of the device shall be indicated e.g. “For In vitro
diagnostics use” or graphical symbol: “In vitro diagnostic medical device”,
(xii) Where a component is too small to contain all the above information, it must at a
minimum contain Name, lot number, expiration date, volume, and storage
conditions,
(xiii) If the product requires associated instrumentation, the above requirements also
apply to the instrument,
(xiv) The instrument should clearly display information regarding its status as a new or
reprocessed product.

4.2 Instructions for use

A copy of the current instructions for use must be submitted in the dossier and should include
the following minimum information:
(i) The product name and product code
(ii) The name and contact details of the manufacturer or an authorized representative
of the manufacturer, in order for the user to obtain assistance
(iii) A clearly stated intended use, including:

• what is detected by the assay (that is, the analytical use of the assay
e.g. the marker or nucleic acid sequence being detected)
• the clinical indication for the test (e.g. if it is for a specific disorder, or a condition
or risk factor of interest that the test is intended to detect, define or differentiate)
• the function of the product (screening, monitoring, diagnostic or aid to diagnosis,
staging or aid to staging of disease)
• the intended user (laboratory professional and/or at point-of-care)
• the intended testing population (e.g. neonates, antenatal women)
• the type of specimen(s) required (e.g. serum, plasma, whole blood, sputum,
urine, csf etc. )
• Whether the assay is automated
• What the instrument is intended for
• Whether the test is qualitative or quantitative
• An indication that the product is for in vitro use
• A general description of the principle of the assay method or instrument
principles of operation
• A description of all components of the assay (e.g. reagents, assay controls and
calibrators) and a description of the reactive ingredients of relevant components
(e.g. antibodies, antigens, nucleic acid primers etc.)

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 • A description of the specimen collection and transport materials provided with
the product or recommended for use
• For instruments of automated assays: a description of the appropriate assay
characteristics or dedicated assays
• For automated assays: a description of the appropriate instrumentation
• characteristics or dedicated instrumentation
• If applicable, a description of any software to be used with the product
• If applicable, a description or complete list of the various configurations/variants
of product that will be made available
• If applicable, a description of the accessories, and other products that are
intended to be used in combination with the product but are not provided with
the product
• Storage conditions, including storage conditions and stability of both the
unopened and opened product, and working solutions. When applicable, these
instructions should include such information as conditions of temperature, light,
humidity, and other pertinent factors
• Specimen exclusion criteria (e.g. specimens with visual evidence of
hyperlipideamia or haemolysis, excessive specimen age, excessive number of
freeze/thaw cycles)
• If the test kit includes sterile accessories, an indication of that condition and any
necessary instructions in the event of damage to sterile packaging
• If the test kit includes accessories that have been specified by the manufacturer
as intended for single-use only, an indication of that stat
• Clear instructions on how to perform the assay, including instructions on
specimen collection, handling, preparation and storage of reagents, the use of
assay calibrators and controls and the interpretation of results
• Recommendations for quality control procedures
• Clear instructions on the correct usage of any equipment or software that is
required for the performance of the assay
• Any warning and precautions to be considered related to the use of the assay
including but not limited to interpreting the results, the disposal of the assay
and/or its accessories (e.g. lancets), to any consumables used with it (e.g.
reagents) that may be carcinogenic, mutagenic or toxic, or to any potentially
infectious substances of human or animal origin
• Any residual risks.
• Precautions and measures to be taken in the event of performance changes or
product malfunction
• Limitations of the assay, including information on interfering substances that
may affect the performance of the assay

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 • Performance characteristics such as clinical sensitivity and specificity,
seroconversion sensitivity, accuracy, dynamic range, lower limit of detection,
reproducibility, and any other performance aspects that are relevant to the
product
• Any requirements for special training or particular qualifications of the assay
user
• Any requirements for routine maintenance. Include details of frequency of
maintenance and who should perform this maintenance (for example: the user, a
representative of the manufacturer, or a third party)
• Where relevant, a bibliography
• Document control details, such as a document version number and release date.

4.3 Instrument manual

If the product requires associated instrumentation, include a hard copy and softcopy of the
instrument manual and/or associated operator manuals. If the instrument manual is large, an
electronic version may be included instead of a hard copy.

4.4 Any other instruction material provided to the user

a) Provide copies of any other instructional materials that need to be provided to the user.

b) In case the device is intended to be sold to the general public, labeling information:-

(i) Shall be set out on the outside of the package that contains the device; and be visible
under normal conditions of sale.

(ii) where a package that contains a device is too small to display all the information in
accordance with (i) above, the directions for use shall accompany the device but
need not be set out on the outside of the package or be visible under normal
conditions of sale.

(iii) Specimen label(s), promotional material(s) and user manual(s) should be provided.

Note:
Requirements that have been described in a respective standard should also be followed when
labeling a device.

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 Annex I

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

CLASSIFICATION RULES FOR IN VITRO DIAGNOSTIC DEVICES

Rule 1

IVDDs intended for the following purposes are classified as Class D:

• Devices intended to be used to detect the presence of, or exposure to, a transmissible
agent in blood, blood components, blood derivatives, cells, tissues or organs in order to
assess their suitability for transfusion or transplantation, or
• Devices intended to be used to detect the presence of, or exposure to, a transmissible
agent that causes a life-threatening, often incurable, disease with a high risk of
propagation

Rationale:

The application of this rule as defined above should be in accordance with the rationale that
follows: Devices in this Class are intended to be used to ensure the safety of blood and blood
components for transfusion and/or cells, tissues and organs for transplantation. In most cases,
the result of the test is the major determinant as to whether the donation/product will be used.
Serious diseases are those that result in death or long-term disability, that are often incurable or
require major therapeutic interventions and where an accurate diagnosis is vital to mitigate the
public health impact of the condition.

Examples

Tests to detect infection by HIV, HCV, HBV, HTLV. This Rule applies to first-line assays,
confirmatory assays and supplemental assays.

Rule 2

IVDDs intended to be used for blood grouping, or tissue typing to ensure the immunological
compatibility of blood, blood components, cells, tissue or organs that are intended for
transfusion or transplantation, are classified as Class C, except for

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ABO system [A (ABO1), B (ABO2), AB (ABO3)], rhesus system [RH1 (D), RH2 (C), RH3
(E) , RH4 (c), RH5 (e)], Kell system [Kel1 (K)], Kidd system [JK1 (Jka), JK2 (Jkb)] and Duffy
system [FY1 (Fya), FY2 (Fyb)] determinations which are classified as Class D.

Rationale:

The application of this rule as defined above should be in accordance with the rationale for this
rule which is as follows: A high individual risk, where an erroneous result would put the
patient in an imminent life-threatening situation places the device into Class D. The rule divides
blood grouping devices into two subsets, Class C or D, depending on the nature of the blood
group antigen the IVDD is designed to detect, and its importance in a transfusion setting.

Examples:

HLA, Duffy system (other Duffy systems except those listed in the rule as Class D are in Class
C).

Rule 3

IVDDs are classified as Class C if they are intended for use:

• in detecting the presence of, or exposure to, a sexually transmitted agent. Examples:
Sexually transmitted diseases, such as Chlamydia trachomatis, Neisseria gonorrhoeae.
• in detecting the presence in cerebrospinal fluid or blood of an infectious agent with a
risk of limited propagation. Examples: Neisseria meningitis or Cryptococcus neoformans.
• in detecting the presence of an infectious agent where there is a significant risk that an
erroneous result would cause death or severe disability to the individual or fetus being
tested. Examples: diagnostic assay for CMV, Chlamydia pneumoniae, Methycillin
Resistant Staphylococcus aureus.
• in pre-natal screening of women in order to determine their immune status towards
transmissible agents. Examples: Immune status tests for Rubella or Toxoplasmosis.
• in determining infective disease status or immune status, and where there is a risk that
an erroneous result will lead to a patient management decision resulting in an
imminent life-threatening situation for the patient. Examples: Enteroviruses, CMV and
HSV in transplant patients.
• in screening for selection of patients for selective therapy and management, or for or
for disease staging, or in the diagnosis of cancer. Example: personalized medicine.

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 NOTE: those IVDDs where the therapy decision would usually be made only after
further investigation and those used for monitoring would fall into class B under rule
6.
• in human genetic testing. Examples: huntington ’s disease, Cystic Fibrosis.
• to monitor levels of medicines, substances or biological components, when there is
a risk that an erroneous result will lead to a patient management decision resulting in
an immediate life-threatening situation for the patient. Examples: Cardiac markers,
Cyclosporin, Prothrombin time testing.
• In the management of patients suffering from a life-threatening infectious disease.
Examples: HCV viral load, HIV Viral Load and HIV and HCV geno- and sub-typing.
• In screening for congenital disorders in the fetus. Examples: Spina Bifida or Down
Syndrome.

Rationale:

The application of this rule as defined above should be in accordance with the rationale for this
rule which is as follows: Devices in this Class present a moderate public health risk, or a high
individual risk, where an erroneous result would put the patient in an imminent life-
threatening situation, or would have a major negative impact on outcome. The devices provide
the critical, or sole, determinant for the correct diagnosis. They may also present a high
individual risk because of the stress and anxiety resulting from the information and the nature
of the possible follow-up measures.

Rule 4

IVDDs intended for self-testing are classified as Class C, except those devices from which the
result is not determining a medically critical status, or is preliminary and requires follow-up
with the appropriate laboratory test in which case they are Class B.

IVDDs intended for blood gases and blood glucose determinations for near-patient testing
would be Class C. Other IVDDs that are intended for near-patient should be classified in their
own right using the classification rules.

Rationale:

The application of this rule as defined above should be in accordance with the rationale for this
rule which is as follows: In general, these devices are used by individuals with no technical
expertise and thus the labelling and instructions for use are critical to the proper outcome of the
test.

Example for self-testing class C: Blood glucose monitoring, addition data required
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Example for self-testing class B: Pregnancy self test, Fertility testing, Urine test- strips.

Rule 5

The following IVDDs are classified as Class A:

• Reagents or other articles which possess specific characteristics, intended by the

manufacturer to make them suitable for in vitro diagnostic procedures related to a
specific examination.
• Instruments intended by the manufacturer specifically to be used for in vitro
diagnostic procedures.
• Specimen receptacles.

Note: Any product for general laboratory use not manufactured, sold or represented for use in
specified in vitro diagnostic applications are not deemed to be IVDDs, as defined in this
document. However, in certain jurisdictions products for general laboratory use are
considered to be IVDDs.

Rationale:

The application of this rule as defined above should be in accordance with the rationale for
this rule which is as follows: These devices present a low individual risk and no or minimal
public health risk.

Examples:

Selective/differential microbiological media (excluding the dehydrated powders which are

considered not to be a finished IVDD), identification kits for cultured microorganisms, wash
solutions, instruments and plain urine cup.

Note 1: In certain jurisdictions there may be differences as to whether a device classified in this
rule is considered an IVDD.

Note 2: The performance of software or an instrument that is specifically required to perform a

particular test will be assessed at the same time as the test kit.

Note 3: The interdependence of the instrument and the test methodology prevents the
instrument from being assessed separately, even though the instrument itself is still
classified as Class A.

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 Rule 6

IVDDs not covered in Rules 1 through 5 are classified as Class B.

Rationale:

The application of this rule as defined above should be in accordance with the rationale for this
rule which is as follows: These devices present a moderate individual risk as they are not likely
to lead to an erroneous result that would cause death or severe disability, have a major negative
impact on patient outcome or put the individual in immediate danger. The devices give results
that are usually one of several determinants. If the test result is the sole determinant however
other information is available, such as presenting signs and symptoms or other clinical
information which may guide a physician, such that classification into Class B may be justified.
Other appropriate controls may also be in place to validate the results. This Class also includes
those devices that present a low public health risk because they detect infectious agents that are
not easily propagated in a population.

Examples:
Blood gases, H. pylori and physiological markers such as hormones, vitamins, enzymes,
metabolic markers, specific IgE assays and celiac disease markers.

Rule 7

IVDDs that are controls without a quantitative or qualitative assigned value will be classified as
Class B.

Rationale:

For such controls, the qualitative or quantitative value is assigned by the user and not the
manufacturer.

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 Annex II
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

IVDD Post Market Surveillance Report Submission Form

Submission Details

Product name:
Manufacturer:
Classification of IVDD:
Date Registration of IVDD:

TABLE 1

Report date Reviewed by Date of review

Post market surveillance report #1
Post market surveillance report #2

Post market surveillance report #3

Post market surveillance report #4

TABLE 2 POST MARKET SURVEILLANCE REPORT

Date product went on the market

Number of units sold

Number of complaints
Complaint rate
Have there been any trends identified in
relation to complaints
Number of adverse events

Number of adverse events rest of world

Were there any unforeseen risks?
Number of vigilance reports to Competent
Authority

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Vigilance report rate
Number of worldwide reportable incidents
Number of product recalls in Tanzania
Number of product recalls worldwide
Were there any corrective actions arising
from complaints or adverse events
What is the status of the corrective action
Who authorized the post market
surveillance report
Did a clinical expert review this post
market surveillance
Please provide bio /CV of author
Please provide bio/CV of clinical expert

In the case of CAPA’S or recalls please give details below:

SECTION 1: DETAILED DESCRIPTION OF COMPLAINTS:

Detailed description of complaints Tanzania:

Please indicate in each event if the complaints were due to:

1. User error
2. Procedure error
3. Product malfunction
4. Unanticipated events
5. Alleged direct harm
caused to the patient or
user of the device

Are there any new emerging risks: Yes No

Discuss new risks if applicable :

Has an external clinical expert been engaged to review the new risks?

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Detailed description of complaints:

Please indicate in each event if the adverse events were due to:
1. User error
2. Procedure error
3. Product malfunction
Are there any new emerging risks: YES NO
Discuss new risks if applicable :

If recalls occurred please discuss

SECTION 2: VIGILANCE REPORTING

Has a vigilance report been sent to a Competent

Authority: Yes No

Has a vigilance report been sent to NSAI: Yes No

Please list all vigilance reports with identifier number:

If yes, discuss each report in detail and provide copies of the reports, if not already
submitted to NSAI:

SECTION 3: RISK MANAGEMENT

Has the risk management file been updated to reflect these

Yes No
events:

Has the CER been updated to reflect these events: Yes No

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Does the benefit of the product still outweigh the risk
Yes No
taking account “State of the Art” :

SECTION 4: PERFORMANCE

Is the device performing as intended, in line with the

Yes No
design of the device?

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 Annex III

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

APPLICATION FORM FOR VARIATION OF A REGISTERED MEDICAL

DEVICE INCLUDING IN VITRO DIAGNOSTIC DEVICE

1 Brand name

1.1 Device classification:

1.2 Intended use:

2 Model/series/system (if applicable)

3 Type of change(s) (state which type of variation)

3.1 Scope (Please specify scope of the change(s) in a concise way)

3.2 Background for change & Justification for change(s) (if applicable) Please give brief
background explanation for the proposed change(s) to your marketing
authorization as well as a justification in case of consequential change(s)
3.3 Present 3.4 Proposed
(Please specify precise current (Please specify precise proposed
wording or specification) wording or specification)

Registrant should always enclose a working model clearly showing the differences between
the proposed version and the current version.

4 Details of Registrant (must be the holder of the marketing

authorization/registration certificate)

Name:
Business Address:
Postal Address:
Country
Phone: Fax: Email:

…………………….. …………………….. ……………………….

Name Date Signature and stamp

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 Annex IV

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

APPLICATION FORM FOR RENEWAL OF A REGISTERED MEDICAL DEVICE

INCLUDING IN VITRO DIAGNOSTIC DEVICE

Brand name:

Generic name:

Registration number:

Risk Class:

GMDN Code:

GMDN Category:

Model /Series/System (if

applicable)

Packing/pack size (if applicable)

Name and address (physical and postal) of

Applicant (Must be the holder of the
marketing authorization/registration
certificate)

Name and address (es) of the

manufacturer(s) of the IVDD. (Add as
many rows as necessary)

Name and address of the

manufacturing site

Name and complete address of the Local

Responsible Person (who must be resident in
Tanzania and in case of company be incorporated
in Tanzania)

Detailed device description

(Additional information can be
attached with this form)
Is there any change(s) to the device /

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manufacturing process (Yes/ No)

If Yes, please provide details for the change(s)

made. If change(s) is/are major apply for new
registration
Other Application(s) (Please provide brief information on any ongoing variation variation(s) submitted
in parallel with renewal application(s) or line-extension(s))

Declaration of the Applicant:

I hereby submit an application for the above Marketing Authorization to be renewed

in accordance to conditions given above.
I declare that (Please tick the appropriate declarations):

There are no other changes than those identified in this application (except for
those addressed in other variations submitted in parallel; such parallel variations
have to be specified under ‘Other Application(s)’);

Where applicable, registration fees have been paid; Name:

Name: _________________________________________________

Qualification:___________________________________________

Position in the company: _________________________________

Signature:______________________________________________

Date:___________________________________________________

Official stamp:

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 Annex V

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

APPLICATION FORM FOR REGISTRATION OF IN VITRO DIAGNOSTIC DEVICES

Please read this section carefully before completing the form

1. Please check the corresponding boxes in the “Encl.” column if any document is
enclosed and indicate the respective indexes in the submission folder
2. Please check the boxes as appropriate

Note Part A: Particulars of Applicant Encl.

A1 Applicant’s name
Post Code: Country:
Contact Person: Telephone:
Fax: E-mail:
Website:

Part B: Particulars of the Manufacturing site

Name
Physical address of the site
B1
Post Code: Country:
Contact Person: Telephone:
Fax: E-mail:
Website:

Quality Management System Established by the Manufacturer

Standards with which the system complies:

B2
ISO 9001 (current version)

ISO13485 (current version)

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 Manufacturing site Quality Audit

Others (please
specify)

System certified by _________________________________, and a certified

copy of the certificate is enclosed.

Indicate areas covered by Quality Management System

Device design,

Production

Post-production processes

Others (please specify)

Part C: Particulars of Local Responsible Person (LRP)

C1 LRP’s name
Address (Please give the
registered place of business, if any)

Contact person: Telephone:

Fax: E-mail:
Contact telephone for public enquiries (if different from the number
given above):

Certified copy of business registration certificate with business

registration number: is enclosed

C2 Power of attorney authorizing the LRP is enclosed

C3 The LRP is also an importer of the device named in Part D

Part D: Particulars of the IVDD

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D1 Generic name of the
IVDD

D2 Brand name of the

IVDD

D3 Model /Series/System
(if applicable)

D4 Reagents/ Controls (if

applicable)

D5 Country of origin

D6 Description of the IVDD (Please enter appropriate GMDN description. If

none of the descriptions in GMDN appear appropriate, enter a short
description of the device)

D7 GMDN Code: (Please enter if known)

D8 Other common descriptions of the IVDD:

D9 Intended use of the

IVDD:

Class of the IVDD:

D10 Class A

Class B

Class C

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 Class D

D11 Reasons for classifying the IVDD as Class A, B, C or D device:

History

No previous recalls, reportable adverse incidents, banning in other

countries or post-market surveillance studies
D12
Yes (Please tick the appropriate boxes and provide details):

Recalls completed or in progress

Any reportable adverse incidents bearing implications to the
device
The device banned previously in other countries
Pro-active post-market surveillance studies

Performance and Safety

D13 International or national standards with which the IVDD complies

(Please enclose copy of the standard)

Part E: Marketing Approvals in Foreign countries

E1 Mention the countries where the IVDD has obtained marketing

approvals

(Please enclose certified copy of valid marketing authorization)

E2 Mention the countries where the IVDD approval is still pending

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 Part F: Declaration of conformity (DoC)

F1 Submit a written declaration of conformity. The DoC should contain the

following:-
(i) An attestation that a device complies with the applicable
EPSP, has been classified accordingly and has met applicable
conformity assessment elements.
(ii) Information sufficient to identify the device including its
nomenclature.
(iii) The risk class allocated to the IVDD.
(iv) Which of the conformity assessment elements have been
applied.
(v) The date from which the DoC is valid.
(vi) The name and address of the IVDD manufacturer.
(vii) The name, position and signature of the responsible person
who has been authorized to complete the DoC.

Note: The Essential Principles of Safety and Performance which apply to the
IVDD are appended.

Declaration by applicant

I, the undersigned certify that all the information in this form and accompanying documentation
is correct and true to the best of my knowledge.

Name:

Position:

Signature:

Date:

Official stamp:

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 Annex VI

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ESSENTIAL REQUIREMENTS CHECK LIST

Brand name : Generic name: RISK CLASS:

Clause Essential Principal Applicable to the Method of Identity of specific

device? Conformity Documents
1. GENERAL REQUIREMENTS

Medical devices should be designed and manufactured in such a way that,

when used under the conditions and for the purposes intended and, where
applicable, by virtue of the technical knowledge, experience, education or
training, and the medical and physical conditions of intended users, they will
perform as intended by the manufacturer and not compromise the clinical
condition or the safety of patients, or the safety and health of users or, where
applicable, other persons, provided that any risks which may be associated
with their use constitute acceptable risks when weighed against the benefits to
the patient and are compatible with a high level of protection of health and
safety.

2. The solutions adopted by the manufacturer for the design and

manufacture of the devices should conform to safety principles, taking

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 account of the generally acknowledged state of the art. When risk reduction is
required, the manufacturer should control the risk(s) so that the residual
risk(s) associated with each hazard is judged acceptable. The manufacturer
should apply the following principles in the priority order listed:
identify known or foreseeable hazards and estimate the associated
risks arising from the intended use and foreseeable misuse;
eliminate risks as far as reasonably practicable through inherently
safe design and manufacture;
reduce as far as is reasonably practicable the remaining risks by
taking adequate protection measures, including alarms; and
inform users of any residual risks.

3. Medical devices should achieve the performance intended by the

manufacturer and be designed and manufactured in such a way that they are
suitable for their intended purpose.

4. The characteristics and performances referred to in Clauses 1, 2 and 3 should

not be adversely affected to such a degree that the health or safety of the
patient or the user and, where applicable, of other persons are compromised
during the lifetime of the device, as indicated by the manufacturer, when the
device is subjected to the stresses which can occur during normal conditions
of use and has been properly maintained in accordance with the
manufacturer’s instructions.

5. Medical devices should be designed, manufactured and packaged in such a

way that their characteristics and performances during their intended use will
not be adversely affected by transport and storage conditions (for example,
fluctuations of temperature and humidity) taking account of the instructions
and information provided by the manufacturer.

6. Medical devices should achieve their intended performance during normal

conditions of use. All known, and foreseeable risks, and any undesirable
effects, should be minimized and be acceptable when weighed against the
benefits of the intended performance.

ESSENTIAL PRINCIPLES APPLICABLE TO MEDICAL DEVICES

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 OTHER THAN IVDDS

7. DESIGN AND MANUFACTURING REQUIREMENTS

7.1 Chemical, physical & biological properties

The devices should be designed and manufactured in such a way as to ensure
the characteristics and performance referred to in clause 6.
Particular attention should be paid to:
the choice of materials used, particularly as regards toxicity and, where
appropriate, flammability,
the compatibility between the materials used and biological tissues, cells,
and body fluids taking account of the intended purpose of the device.
the choice of materials used should reflect, where appropriate, matters such as
hardness, wear and fatigue strength.;

7.2 The devices should be designed, manufactured and packaged in such a way
as to minimize the risk posed by contaminants and residues to the persons
involved in the transport, storage and use of the devices and to patients,
taking account of the intended purpose of the product. Particular attention
should be paid to tissues exposed and to the duration and frequency of
exposure.

7.3 The devices should be designed and manufactured in such a way that they
can be used safely with the materials, substances and gases with which they
enter into contact during their normal use or during routine procedures; if the
devices are intended to administer medicinal products they should be
designed and manufactured in such a way as to be compatible with the
medicinal products concerned according to the provisions and restrictions
governing these products and that their performance is maintained in
accordance with the intended use.
7.4 The devices should be designed and manufactured in such a way as to reduce
as far as reasonably practicable and appropriate the risks posed by substances
that may leach or leak from the device. Special attention shall be given to
substances which are carcinogenic, mutagenic or toxic to reproduction.

7.5 Devices should be designed and manufactured in such a way as to reduce as

far as reasonably practicable and appropriate risks posed by
the unintentional ingress or egress of substances into or from the

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 device taking into account the device and the nature of the environment in
which it is intended to be used.

8. Infection & microbial contamination

8.1 The devices and manufacturing processes should be designed in such a way
as to eliminate or to reduce as far as reasonably practicable and appropriate
the risk of infection to patients, users and, where applicable, other persons.
The design should:
• allow easy handling, and, where necessary:
• reduce as far as reasonably practicable and appropriate any
microbial leakage from the device and/or microbial exposure during
use,
• prevent microbial contamination of the device or specimen, where
applicable, by the patient, user or other person.
8.2 Devices labelled as having a special microbiological state should be designed,
manufactured and packaged to ensure they remain so when placed on the
market and remain so under the transport and storage conditions specified by
the manufacturer.

8.3 Devices delivered in a sterile state should be designed, manufactured and

packaged in a non-reusable pack, and/or according to appropriate
procedures, to ensure that they are sterile when placed on the market and
remain sterile, under the transport and storage conditions indicated by the
manufacturer, until the protective packaging is damaged or opened.

8.4 Devices labelled either as sterile or as having a special microbiological state

should have been processed, manufactured and, if applicable, sterilized by
appropriate, validated methods.

8.5 Devices intended to be sterilized should be manufactured in appropriately

controlled (e.g. environmental) conditions.

8.6 Packaging systems for non-sterile devices should maintain the integrity and
cleanliness of the product and, if the devices are to be sterilized prior to use,
minimize the risk of microbial contamination; the packaging system should be
suitable taking account of the method of sterilization indicated by the
manufacturer.

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8.7 The labelling of the device should distinguish between identical or similar
products placed on the market in both sterile and non-sterile condition.

9. Medical devices incorporating a substance considered to be a

medicinal product/drug
9.1 Where a device incorporates, as an integral part, a substance which, if used
separately, may be considered to be a medicinal product/drug as defined in
the relevant legislation that applies within that jurisdiction and which is liable
to act upon the body with action ancillary to that of the device, the safety,
quality and performance of the device as a
whole should be verified, as well as the safety, quality and efficacy of the
substance in the specific application,
10. Medical devices incorporating materials of biological origin

10.1 In some jurisdictions products incorporating tissues, cells and substances of

animal origin may be considered medical devices. In this case, such tissues,
cells and substances should originate from animals that have been subjected
to veterinary controls and surveillance adapted to the intended use of the
tissues. National regulations may require that the manufacturer and/or the
Regulatory Authority retain information on the geographical origin of the
animals. Processing, preservation, testing and handling of tissues, cells and
substances of animal origin should be carried out so as to provide optimal
safety for patients, users and, where applicable, other persons. In particular,
safety with regard to viruses and other transmissible agents should be
addressed by implementation of validated methods of elimination or
inactivation in the course of the
manufacturing process.
10.2 In some jurisdictions products incorporating human tissues, cells and
substances may be considered medical devices. In this case, the selection of
sources, donors and/or substances of human origin, the processing,
preservation, testing and handling of tissues, cells and substances of such
origin should be carried out so as to provide optimal safety for patients, users
and, where applicable, other persons. In particular, safety with regard to
viruses and other transmissible agents should be addressed by
implementation of validated methods of elimination or inactivation in the
course of the
manufacturing process.
10.3 In some jurisdictions products incorporating cells and substances of
microbial origin may be considered medical devices. In this case,

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 processing, preservation, testing and handling of cells and substances should
be carried out so as to provide optimal safety for patients, users and, where
applicable, other persons. In particular, safety with regard to viruses and
other transmissible agents should be addressed by implementation of
validated methods of elimination or inactivation in the course of the
manufacturing process.

11. Manufacturing and environmental properties

11.1 If the device is intended for use in combination with other devices or
equipment, the whole combination, including the connection system should
be safe and should not impair the specified performance of the devices. Any
restrictions on use applying to such combinations should be indicated on the
labelling and/or in the instructions for use. Connections which the user has to
handle, such as fluid, gas transfer or mechanical coupling, should be
designed and constructed in such a way as to minimize all possible risks from
incorrect connection.
11.2 Devices should be designed and manufactured in such a way as to remove or
reduce as far as reasonably practicable and appropriate:
• the risk of injury to the patient, user or other persons in
connection with their physical and ergonomic features,
• the risk of use error due to the ergonomic features, human factors and
the environment in which the device is intended to be used;
• risks connected with reasonably foreseeable external influences or
environmental conditions, such as magnetic fields, external electrical and
electromagnetic effects, electrostatic discharge, radiation associated with
diagnostic or therapeutic procedures, pressure, humidity, temperature or
variations in pressure and acceleration;
• the risks associated with the use of the device when it comes into
contact with materials, liquids, and gases to which it is exposed during
normal conditions of use;
• the risk associated with the possible negative interaction between
software and the environment within which it operates and interacts;
• the risks of accidental penetration of substances into the device;
• the risk of incorrect identification of specimens;
• the risks of reciprocal interference with other devices normally used
in the investigations or for the treatment given;
• risks arising where maintenance or calibration are not possible (as with
implants), from ageing of materials used or loss of accuracy of

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 any measuring or control mechanism.

11.3 Devices should be designed and manufactured in such a way as to minimize

the risks of fire or explosion during normal use and in single fault condition.
Particular attention should be paid to devices whose intended use includes
exposure to or use in association with flammable substances or substances
which could cause combustion.

11.4 Devices must be designed and manufactured in such a way as to facilitate the
safe disposal of any waste substances.

12. Devices with a diagnostic or measuring function.

12.1 Devices with a measuring function, should be designed and manufactured in

such a way as to provide sufficient accuracy, precision and stability for their
intended purpose of the device, based on appropriate scientific and technical
methods. The limits of accuracy should be indicated by the manufacturer.

12.2 Diagnostic devices should be designed and manufactured in such a way as to

provide sufficient accuracy, precision and stability for their intended use,
based on appropriate scientific and technical methods.

12.3 Any measurement, monitoring or display scale should be designed in line

with ergonomic principles, taking account of the intended purpose of the
device.

12.4 Wherever possible values expressed numerically should be in commonly

accepted, standardized units, and understood by the users of the device.

13. Protection against radiation

13.1 General

13.1.1 Devices should be designed and manufactured and packaged in such a way
that exposure of patients, users and other persons to any emitted radiation
should be reduced as far as practicable and appropriate, compatible with the
intended purpose, whilst not restricting the application of appropriate
specified levels for therapeutic and diagnostic purposes.

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13.2 Intended radiation

13.2.1 Where devices are designed to emit hazardous, or potentially hazardous,

levels of visible and/or invisible radiation necessary for a specific medical
purpose the benefit of which is considered to outweigh the risks inherent in
the emission, it should be possible for the user to control the emissions. Such
devices should be designed and manufactured to ensure reproducibility of
relevant variable parameters within an acceptable tolerance.

13.2.2 Where devices are intended to emit potentially hazardous, visible and/or
invisible radiation, they should be fitted, where practicable, with visual
displays and/or audible warnings of such emissions.

13.3 Unintended radiation

Devices should be designed and manufactured in such a way that exposure of
13.3.1
patients, users and other persons to the emission of unintended, stray or
scattered radiation is reduced as far as practicable and appropriate.

13.4 Instructions

13.4.1 The operating instructions for devices emitting radiation must give detailed
information as to the nature of the emitted radiation, means of protecting the
patient and the user and on ways of avoiding misuse & of eliminating the
risks inherent in installation.

13.5 Ionising radiation

Devices intended to emit ionizing radiation should be designed and
13.5.1
manufactured in such a way as to ensure that, where practicable, the quantity,
geometry and energy distribution (or quality) of radiation emitted can be
varied and controlled taking into account the intended use.

13.5.2 Devices emitting ionizing radiation intended for diagnostic radiology should
be designed and manufactured in such a way as to achieve appropriate image
and/or output quality for the intended medical purpose whilst minimizing
radiation exposure of the patient and user.
.

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13.5.3 Devices emitting ionizing radiation, intended for therapeutic radiology
should be designed and manufactured in such a way as to enable reliable
monitoring and control of the delivered dose, the beam type and energy and
where appropriate the energy distribution of the radiation beam.

14. Medical devices that incorporate software and standalone medical device
software
Devices incorporating electronic programmable systems, including software,
14.1 or standalone software that are devices in themselves, should be designed to
ensure repeatability, reliability and performance according to the intended
use. In the event of a single fault condition, appropriate means should be
adopted to eliminate or reduce as far as practicable and appropriate
consequent risks.

14.2 For devices which incorporate software or for standalone software that are
devices in themselves, the software must be validated according to the state of
the art taking into account the principles of development lifecycle, risk
management, validation and verification.

15. Active medical devices and devices connected to them

15.1 For active medical devices, in the event of a single fault condition, appropriate
means should be adopted to eliminate or reduce as far as practicable and
appropriate consequent risks.

15.2 Devices where the safety of the patients depends on an internal power supply
should be equipped with a means of determining the state of the power
supply.

15.3 Devices where the safety of the patients depends on an external power supply
should include an alarm system to signal any power failure.

15.4 Devices intended to monitor one or more clinical parameters of a patient

should be equipped with appropriate alarm systems to alert the user of
situations which could lead to death or severe deterioration of the patient's
state of health

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15.5 Devices should be designed and manufactured in such a way as to reduce as
far as practicable and appropriate the risks of creating electromagnetic
interference which could impair the operation of this or other devices or
equipment in the usual environment.
15.6 Devices should be designed and manufactured in such a way as to provide an
adequate level of intrinsic immunity to electromagnetic disturbance to enable
them to operate as intended.

15.7 Devices should be designed and manufactured in such a way as to avoid, as

far as reasonably practicable, the risk of accidental electric shocks to the
patient, user or any other person, both during normal use of the device and in
the event of a single fault condition in the
device, provided the device is installed and maintained as indicated by the
manufacturer
16.0 Protection against mechanical risks

16.1 Devices should be designed and manufactured in such a way as to protect the
patient and user against mechanical risks connected with, for example,
resistance to movement, instability and moving parts.

16.2 Devices should be designed and manufactured in such a way as to reduce to

the lowest practicable level the risks arising from vibration generated by the
devices, taking account of technical progress and of the means available for
limiting vibrations, particularly at source, unless the vibrations are part of the
specified performance.

16.3 Devices should be designed and manufactured in such a way as to reduce to

the lowest practicable level the risks arising from the noise emitted, taking
account of technical progress and of the means
available to reduce noise, particularly at source, unless the noise emitted is
part of the specified performance
16.4 Terminals and connectors to the electricity, gas or hydraulic and pneumatic
energy supplies which the user has to handle should be
designed and constructed in such a way as to minimize all possible risks.

16.5 Accessible parts of the devices (excluding the parts or areas intended to
supply heat or reach given temperatures) and their surroundings
should not attain potentially dangerous temperatures under normal use.

17.0 Protection against the risks posed to the patient or user by

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 supplied energy or substances

17.1 Devices for supplying the patient with energy or substances should be
designed and constructed in such a way that the delivered amount can be set
and maintained accurately enough to guarantee the safety of the patient and
of the user
17.2 Devices should be fitted with the means of preventing and/or indicating any
inadequacies in the delivered amount which could pose a danger. Devices
should incorporate suitable means to prevent, as
far as possible, the accidental release of dangerous levels of energy or
substances from an energy and/or substance source.
17.3 The function of the controls and indicators should be clearly specified on the
devices. Where a device bears instructions required for its operation or
indicates operating or adjustment parameters by means of a visual system,
such information should be understandable to the
user and, as appropriate, the patient.
18.0 Protection against the risks posed by medical devices intended by the
manufacturer for use by lay persons

18.1 Devices for use by lay persons should be designed and manufactured in such
a way that they perform appropriately for their intended purpose taking into
account the skills and the means available to lay persons and the influence
resulting from variation that can reasonably be anticipated in the lay person’s
technique and environment. The information and instructions provided by the
manufacturer should be easy for the lay person to understand and apply.

18.2 Devices for use by lay persons should be designed and manufactured in such
a way as to reduce as far as practicable the risk of error during use by the lay
person in the handling of the device and also in
the interpretation of results.
18.3 Devices for use by lay persons should, where reasonably possible, include a
procedure by which the lay person can verify that, at the
time of use, the product will perform as intended by the manufacturer.
19.0 Label and Instructions for Use

19.1 Users should be provided with the information needed to identify the
manufacturer, to use the device safely and to ensure the intended
performance, taking account of their training and knowledge. This
information should be easily understood
20.0 Clinical evaluation

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20.1 For all medical devices, the demonstration of conformity with essential
principles includes a clinical evaluation in accordance with GHTF guidance.
The clinical evaluation should review clinical data in the form of any:
• clinical investigation reports,
• literature reports/reviews, and
• clinical experience to establish that a favourable benefit-risk ratio
exists for the device.
Note: Further information is provided in GHTF/SG5/N2R8:2007
Clinical Evaluation.

20.2 Clinical investigations1 on human subjects should be carried out in accordance

with the spirit of the Helsinki Declaration. This includes every step in the
clinical investigation from first consideration of the need and justification of
the study to publication of the results. In addition, some countries may have
specific regulatory requirements for pre-study protocol review or informed
consent.

Essential Principles applicable to IVDDs

21.0 Chemical, physical and biological properties

21.1 The IVDDs should be designed and manufactured in such a way as to ensure
the characteristics and performance referred to in Section 6. Particular
attention should be paid to the possibility of impairment of analytical
performance due to incompatibility between the materials used and the
specimens and/or analyte (measurand) to be detected (such as biological
tissues, cells, body fluids and micro-organisms) intended to be used with the
device, taking account of its intended
purpose.
21.2 The IVDDs should be designed, manufactured and packaged in such a way as
to minimize the risk posed by contaminants and residues to the persons
involved in the transport, storage and use of the devices and to patients,
taking account of the intended purpose of the
product.
21.3 The IVDDs should be designed and manufactured in such a way as to reduce
as far as reasonably practicable and appropriate the risks
posed by substances that may leach or leak from the IVDDs. Special

1
See GHTF/SG5/N3:2010 Clinical Investigations

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 attention should be given to substances which are carcinogenic,
mutagenic or toxic to reproduction.
21.4 IVDDs should be designed and manufactured in such a way as to reduce as
far as reasonably practicable and appropriate risks posed by the unintentional
ingress or egress of substances into or from the IVDDs taking into account the
device and the nature of the
environment in which it is intended to be used.
22.0 Infection and microbial contamination

22.1 The IVDDs and manufacturing processes should be designed in such a way as
to eliminate or to reduce as far as reasonably practicable and appropriate the
risk of infection to user, professional or lay, or, where applicable, other person
. The design should:
allow easy and safe handling; and, where necessary:
reduce as far as reasonably practicable and appropriate any microbial leakage
from the IVDDs and/or microbial exposure during use; and prevent microbial
contamination of the IVDD or specimen where applicable, by the user,
professional or lay, or other person.
22.2 IVDDs labeled either as sterile or as having a special microbiological state
should be designed, manufactured and packaged to ensure they remain so
when placed on the market and remain so under the transport and storage
conditions specified by the manufacturer, until
the protective packaging is damaged or opened.
22.3 IVDDs labeled either as sterile or as having a special microbiological state
should have been processed, manufactured and, if applicable,
sterilized by appropriate, validated methods.
22.4 IVDDs intended to be sterilized should be manufactured in
appropriately controlled (e.g. environmental) conditions.
22.5 Packaging systems for non-sterile IVDD should maintain the integrity
and cleanliness of the product.
23.0 IVDDs incorporating materials of biological origin

23.1 Where IVDD include tissues, cells and substances originating from animals,
processing, preservation, testing and handling of tissues, cells and substances
of animal origin should be carried out so as to provide optimal safety for user,
professional or lay, or other person.
In particular safety with regard to viruses and other transmissible agents
should be addressed by implementation of validated methods of elimination
or inactivation in the course of the manufacturing process. This may not apply
to certain IVDDs if the activity of the virus and other transmissible agent are
integral to the intended

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 purpose of the IVDD or when such elimination or inactivation process would
compromise the performance of the IVDD.
National regulations may require that the manufacturer and/or the
Regulatory Authority retain information on the geographical origin of the
animals.
23.2 Where IVDDs include human tissues, cells and substances, the selection of
sources, donors and/or substances of human origin, the processing,
preservation, testing and handling of tissues, cells and substances of such
origin should be carried out so as to provide optimal safety for user,
professional or lay, or other person.
In particular safety with regard to viruses and other transmissible agents
should be addressed by implementation of validated methods of elimination
or inactivation in the course of the manufacturing process. This may not apply
to certain IVDDs if the activity of the virus and other transmissible agent are
integral to the intended purpose of the IVDD or when such elimination or
inactivation process would compromise the performance of the IVDD.
23.3 Where IVDDs include cells and substances of microbial origin, processing,
preservation, testing and handling of cells and substances should be carried
out so as to provide optimal safety for user, professional or lay, or other
person.
In particular, safety with regard to viruses and other transmissible agents
should be addressed by implementation of validated methods of elimination
or inactivation in the course of the manufacturing process. This may not apply
to certain IVDDs if the activity of the virus and other transmissible agent are
integral to the intended purpose of the IVDD or when such elimination or
inactivation process
would compromise the performance of the IVDD.
24.0 Manufacturing and environmental properties

24.1 If the IVDD is intended for use in combination with other devices or
equipment, the whole combination, including the connection system should
not impair the specified performance of the devices. Any restrictions on use
applying to such combinations should be indicated
on the label and/or in the instructions for use.
24.2 IVDDs should be designed and manufactured in such a way as to remove or
reduce as far as reasonably practicable and appropriate:
• the risk of injury to user, professional or lay, or other person in
connection with their physical and ergonomic features,
• the risk of use error due to the ergonomic features, human factors
and the environment in which the IVDD is intended to

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 be used;
risks connected with reasonably foreseeable external influences or
environmental conditions, such as magnetic fields, external electrical
and electromagnetic effects, electrostatic discharge, pressure,
humidity, temperature or variations thereof;
the risks associated with the use of the IVDD when it comes into
contact with materials, liquids, and gases to which it is exposed
during normal conditions of use;
the risk associated with the possible negative interaction between
software and the environment within which it operates and interacts;
the risks of accidental penetration of substances into the IVDD;
the risk of incorrect identification of specimens; and
the risks of reasonably foreseeable interference with other
devices such as carry over between IVDDs

24.3 IVDDs should be designed and manufactured in such a way as to minimize

the risks of fire or explosion during normal use and in single fault condition.
Particular attention should be paid to IVDDs whose intended use includes
exposure to or use in association with
flammable substances or substances which could cause combustion.
24.4 IVDDs must be designed and manufactured in such a way as to facilitate the
safe disposal of any waste substances.
25.0 Performance characteristics

25.1 IVDDs should be designed and manufactured in such a way that the
performance characteristics support the intended use, based on appropriate
scientific and technical methods. In particular, where appropriate, the design
should address sensitivity, specificity, accuracy which is trueness and
precision (repeatability and reproducibility), control of known relevant
interference and limits of detection.
These performance characteristics need to be maintained during the lifetime
of the IVDD as indicated by the manufacturer.
25.2 Where the performance of devices depends on the use of calibrators and/or
control materials, the traceability of values assigned to such calibrators
and/or control materials should be assured through
available reference measurement procedures and/or available reference
materials of a higher order.

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25.3 Wherever possible values expressed numerically should be in commonly
accepted, standardized units, and understood by the users of the device.
Note: While SG1 generally supports convergence on the global use of
internationally standardized measurement units, considerations of safety, user
familiarity, and established clinical practice may justify the use of other
recognized measurement units.

26.0 Protection against radiation

26.1 IVDDs should be designed, manufactured and packaged in such a way that
exposure of user, professional or lay, or other person to the emitted radiation
(intended, unintended, stray or scattered) is reduced as far as practicable and
appropriate
26.2 When IVDDs are intended to emit potentially hazardous, visible and/or
invisible radiation, they should as far as practicable and appropriate be:
designed and manufactured in such a way as to ensure that the characteristics
and the quantity of radiation emitted can be controlled and/or adjusted; and
fitted with visual displays and/or audible warnings of such emissions

27.0 IVDDs that incorporate software and standalone IVDD software

For IVDDs which incorporate software or for standalone software that are
27.1 IVDDs in themselves, the software must be validated according to the state of
the art taking into account the principles of development lifecycle, risk
management, verification and validation.

28.0 IVDDs connected to, or equipped with, an energy source

IVDDs where the safety of the patient depends on an internal power supply in
28.1 the IVDD, should be equipped with a means of determining the state of the
power supply.
28.2 IVDDs should be designed and manufactured in such a way as to reduce as far
as practicable and appropriate the risks of creating
electromagnetic interference which could impair the operation of this or other
devices or equipment in the usual environment.
28.3 IVDDs should be designed and manufactured in such a way as to provide an
adequate level of intrinsic immunity to electromagnetic disturbance to enable
them to operate as intended.
28.4 IVDDs should be designed and manufactured in such a way as to
avoid, as far as reasonably practicable, the risk of accidental electric

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 shocks to the user, professional or lay, or other person both during normal use
of the device and in the event of a single fault condition in the device,
provided the IVDD is installed and maintained as indicated
by the manufacturer.
29.0 Protection against mechanical and thermal risks

29.1 IVDDs should be designed and manufactured in such a way as to protect the
user, professional or lay, or other person against mechanical risks connected
with, for example, resistance to movement, instability and moving parts.
Where there are risks due to the presence of moving parts, risks due to break-
up or detachment, or leakage of substances, then appropriate protection
means must be incorporated.

29.2 IVDDs should be designed and manufactured in such a way as to reduce to

the lowest practicable level the risks arising from vibration generated by the
devices, taking account of technical progress and of the means available for
limiting vibrations, particularly at source,
unless the vibrations are part of the specified performance.
29.3 IVDDs should be designed and manufactured in such a way as to reduce to
the lowest practicable level the risks arising from the noise emitted, taking
account of technical progress and of the means
available to reduce noise, particularly at source.
29.4 Terminals and connectors to the electricity, gas or hydraulic and pneumatic
energy supplies which the user, professional or lay, or other person has to
handle should be designed and constructed in such a way as to minimize all
possible risks.
29.5 Accessible parts of the IVDDs (excluding the parts or areas intended to supply
heat or reach given temperatures) and their surroundings
should not attain potentially dangerous temperatures under normal use.

30.0 Protection against the risks posed by IVDDs intended by the manufacturer
for self-testing

30.1 IVDDs intended for self-testing should be designed and manufactured in such
a way that they perform appropriately for their intended purpose taking into
account the skills and the means available to lay persons and the influence
resulting from variation that can reasonably be anticipated in the lay person’s
technique and environment. The
information and instructions provided by the manufacturer should be easy for
the lay person to understand and apply.
30.2 IVDDs intended for self-testing should be designed and manufactured

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 in such a way as to reduce as far as practicable the risk of error by the lay
person in the handling of the device and, if applicable, the
specimen, and also in the interpretation of results.
30.3 IVDDs intended for self-testing should, where reasonably possible, include a
procedure by which the lay person can verify that, at the
time of use, the product will perform as intended by the manufacturer.
31.0 Label and Instructions for Use

31.1 Users should be provided with the information needed to identify the
manufacturer, to use the device safely and to ensure the intended
performance, taking account of their training and knowledge. This
information should be easily understood.
Note: Further information is provided in GHTF/SG1/N43:2005
Labelling for Medical Devices
32.0 Performance evaluation including analytical performance and, where
appropriate, clinical performance

32.1 For an IVDD a performance evaluation should be conducted in accordance

with GHTF guidance. The performance evaluation should review analytical
performance data and, where appropriate, clinical performance data in the
form of any:
• literature;
• performance study reports; and
• experience gained by routine diagnostic testing.
to establish that the IVDD achieves its intended performance during normal
conditions of use and that the known, and foreseeable risks, and any
undesirable effects, are minimized and acceptable when weighed against the
benefits of the intended performance.

The depth and extent of a performance evaluation should be appropriate to

the nature, intended use and risks of the IVDD, and in accordance with GHTF
guidance.

Note: Further information is provided in GHTF/SG1/N46:2008

Principles of Conformity Assessment for IVDDs.
32.2 Clinical performance studies using specimens from human subjects should be
carried out in accordance with the spirit of the Declaration of Helsinki. This
includes every step in the clinical performance study
from first consideration of the need and justification of the study to
publication of the results.

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I declare that the information provided in this form is accurate and correct and the device conforms to all applicable requirements stipulated above.

Name:

Signature:

Position:

Date:

Official stamp:

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 Annex VII

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

IVDD NOTIFICATION FORM

1 Applicant Details
1.1 Status of applicant Manufacturer
(chose one or more) Authorized representative
Importer
1.2 Full address and contact details (phone
number, email address) of the applicant
1.3 Name and contact details (phone number,
email address) of the local responsible
person
2 Details of the Manufacturer
2.1 Name of the Manufacturer
2.2 Full address and contact details (phone
number, email address) of the
manufacturer
3 Details of the IVDD
3.1 Brand name of the device
3.2 Common name or Preferred name
3.3 **Device class
3.4 GMDN Name

3.5 GMDN Code

3.6 Intended use as stated by the

manufacturer
3.7 Intended user of the IVDD Professional
Self User
3.8 Version of the product insert in English Provide copy of relevant IFU
e.g. ABCD 11052012
3.9 Version of the product insert in Swahili Provide copy of relevant IFU
e.g.DCBA11052012
4 Other regulatory approval Provide copy of relevant certificate/s
e.g.USFDA approval, CE marking

Name of authorized person:

Signature:

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Date:
Stamp:

CE: European conformity

**Device class: Classification as per GHTF Rules USFDA:
United States Food and Drug Administration GMDN:
Global Medical Device Nomenclature
IFU: Instruction for Use
IVD: In Vitro Diagnostics

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 All rights reserved

This is a controlled document. It must not be copied without

authorization from the Manager Quality Management or Director of
Business Support or Director General. Only originals or authorized
copies shall be used as working documents.

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