Medical Device Regulation (MDR)

Medical Device Registration

- Global Review

MODERATOR: IR PROF. ALBERT POON

DATE: JAN-MAY 2024
 Contents Page

MEDICAL DEVICE REGISTRATION

- GLOBAL REVIEW

1. The SGS 2013 Country Survey on MD Regulation

2. The GHTF Founding Members (and IMDRF)
3. Some non-GHTF Countries (LAHWP)
4. AHWP Members (26 member economies, mainly in Asia)
5. ASEAN Members (10 SEA Countries)
6. African Countries (PAHWP)

2
 MD REGULATION – GLOBAL REVIEW

1. BASED ON SGS OCT 2013 SUMMARY OF THE MARKET ENTRY

REGULATIONS FOR MD IN THIRTEEN MAIN MARKETS

n Australia n Japan
n Brazil (LAHWP) n Korea
n Canada n Saudi Arabia
n China n Singapore (ASEAN)
n Egypt n Taiwan
n Europe (EU) n United States of America
(USFDA)
n Hong Kong
* Countries in Black colour are not covered by this lecture.
2. The PAHWP – Pan African
3
GHTF re-structured in 2012 and regulators changed to form
International Medical Device Regulatory Forum (IMDRF)
nIMDRF is a voluntary group of medical device regulators from
around the world who have come together to build on the
strong foundational work of the Global Harmonization Task
Force on Medical Devices (GHTF) and aims to accelerate
international medical device regulatory harmonization and
convergence.
nIMDRF was established in October 2011, when
representatives from the medical device regulatory authorities
of Australia, Brazil, Canada, China, European Union, Japan
and the United States, as well as the World Health
Organization (WHO) met in Ottawa to address the
establishment and operation of this new Forum.
4
The current members are:
n Australia, Therapeutic Goods Administration
n Brazil, National Health Surveillance Agency (ANVISA)
n Canada, Health Canada
n China, China Food and Drug Administration
n European Union, European Commission Directorate-General for Internal
Market, Industry, Entrepreneurship and SMEs
n Japan, Pharmaceuticals and Medical Devices Agency and the Ministry of
Health, Labour and Welfare
n Russia, Russian Minstry of Health
n United States of America, US Food and Drug Administration

n The World Health Organization (WHO) and the APEC LSIF Regulatory
Harmonization Steering Committee are Official Observers.
n The Asian Harmonization Working Party (AHWP) and the Pan American
Health Organization (PAHO) are IMDRF Affiliate Organizations.
5
MD REGULATIONS ROUND THE
WORLD

6
Medical Device Registration
Australia
 AUSTRALIA

Regulatory Authority
n The regulatory authority is the Therapeutic
Goods Administration (TGA), part of the
Australian Government Department of Health
and Ageing. The TGA is also the conformity
assessment body for Australian manufacturers
and some foreign sites.

8
 MEDICAL DEVICE REGULATION

Regulations
n The current regulations are the Australian
Therapeutic Goods (Medical Devices)
Regulations 2002. They are supported by
several legislative standards and orders covering
animal tissue, sterilisation and risk management.
n Originally based on EU directive 93/42/EEC, the
Australian regulations can be considered
technically equivalent to this directive, with a few
exceptions.

9
 CLASSIFICATION OF MEDICAL DEVICES

SCOPE AND CLASSIFICATION

n The regulations cover medical devices but not
in-vitro diagnostic (IVD) devices. Classification is
based on the European system of Class I, IIa,
IIb, III and Active Implantable Medical Devices
(which are considered Class III). Classification
rules are not always identical to 93/42/EEC.

I IIa IIb III

10
TECHNICAL DOCUMENTATION
n Technical documentation is required showing
compliance to the Essential Principles of the
regulations. Clinical evidence and risk management
play a very important role in this documentation. The
regulations make certain standards such as ISO
11135 and ISO 11137 effectively mandatory.
n When assessment of technical documentation is
required as part of the pre-market assessment, it is
undertaken by the TGA or by an EU Notified Body
approved by the TGA.

11
ISO 11135-1:2007
n specifies requirements for the development,
validation and routine control of an ethylene
oxide sterilization process for medical devices
ISO 11137-1:2006
n ISO 11137-1:2006 specifies requirements for the
development, validation and routine control of a
radiation sterilization process for medical
devices.

12
QUALITY SYSTEMS
n The standard for quality management systems
(QMS) is ISO 13485:2003 and a QMS audit is
required for manufacturers of all classes except
Class I (not sterile or without a measuring
function).
n The QMS audit is carried out by a Notified Body
as part of the CE mark certification, or by the
TGA. Australian manufacturers must use the
TGA for Australian registration.

13
LOCAL DISTRIBUTORS, LICENCES AND
REGISTRATION
n Foreign manufacturers must have an Australian
sponsor. The sponsor assumes certain
regulatory responsibilities and applies for
registration on the Australian Register of
Therapeutic Goods (ARTG).
n Following registration, devices can be placed on
the market. It should be noted that Global
Medical Device Nomenclature (GMDN) terms
are required for Australian registration.

14
 CURRENT AND FUTURE
DEVELOPMENTS

n The past few years have seen several draft

changes in the regulations, including the
possibility of a combined Australia/New Zealand
regulatory authority; however, a combined
authority is unlikely now. Other significant
changes that are expected include the
appointment of conformity assessment bodies.

15
 NEW ZEALAND

New Zealand
n New Zealand’s medical device regulator is called MedSafe, and
is a business unit of the Ministry of Health. Devices must be
registered on MedSafe’s database, Web Assisted Notification of
Devices (WAND).
n There is no pre-market approval process in New Zealand. A
local sponsor that has the legal responsibility for the medical
device must be identified by the manufacturer. The sponsor
ensures that a medical device is notified to the WAND database
within 30 days of the product being placed on the market.
n A manufacturer must ensure that appropriate documentation
(e.g., certification from FDA, EU or Australia’s TGA)
demonstrating device safety can be furnished to MedSafe upon
request.

16
 Medical Device
Registration
Latin American Countries
 LATIN AMERICA

Common elements of approval process and required submission

documentation for medical device approval in many Latin
American countries. These include:
n A Technical File or Report similar to a CE Technical File (technical
description, device safety test results, biocompatibility data,
labeling, etc).
n A Certificate of Free Sale (CFS) issued by the public health
authority in the country of origin.
n Product registration in most countries is valid for 5 years
n Most countries divide devices into four risk classes (I, II, III, and IV
or similar), ranging from low risk to high risk.
n Many countries require certain regulatory documents to be
translated by a qualified individual into Spanish or Portuguese, as
applicable, and notarized.
18
 LAHWP

n In recent years, efforts have been made to harmonize

legislation in Latin American countries in a manner similar
to the European Union.
n However, no legislative agreements have yet been
definitively established, and local laws continue to vary.
n As a result, some countries may require minimal
information for device registration, while others require
substantial supplemental technical information for the
same device. It is helpful to have local representatives as
part of one’s regulatory team who are knowledgeable
about the local cultures and laws to facilitate preparation of
documents for submission, and to aid in navigating
importation and distribution requirements.

19
 MEXICO

n Mexico’s traditional approval process for medical devices

is notably long (12-18 months). In 2010 a simplified
equivalency process was implemented in Mexico for
devices that are cleared for sale in the U.S. or in Canada,
which can shorten the review process to as few as 30
days. The fast track process requires technical documents
to be translated into Spanish, and includes the following
elements (among others):
n U.S.fast-track required documentation (all must be
translated into Spanish and notarized):
n Certificate to Foreign Government (CFG), a FDA issued
document for export of products that can be legally
marketed in the U.S.

20
n Establishment Inspection Report (EIR) –an FDA site audit
report;
n A copy of the 510(k) or PMA documentation
n Canadian fast-track required documentation:
n A copy of the Medical Device License (MDL) (notarized
Spanish translation);
n CAN/CSA ISO 13485 quality system certificate;
n ISO 17021 Certificate (Proof of CMDCAS accreditation of
third party quality system auditor)

21
Argentina
n Argentina’s device registration time currently averages 4-6 months.
Required documentation for registration includes a Certificate of
Free Sale (CFS), a notarized declaration of Good Manufacturing
Practices and instructions for use translated into Spanish.
Venezuela
n Venezuelan law specifies 20 working days for the device approval
review process. Actual turnaround time for product registration is 1
to 3 months. Registration requirements include provision of 3
letters of recommendation from physicians that have used the
device in another country where the device is approved. Sterilized
devices must also be tested by a local accredited institution as part
of the approval process.

22
Peru
n Device registration in Peru requires a Certificate to Foreign
Government (CFG) (FDA issued document for export of products that
can be legally marketed in the U.S) and a Letter of Authorization.
Chile
n Currently a medical device may be sold in Chile without governmental
authorization, as there are no registration requirements.
Brazil
n Documents required for submission in Brazil include a Trade Permit
issued by the State, samples of labels and instructions for use
translated into Portuguese, and a description of all manufacturing and
quality control process steps. A Technical Report is required which
includes a list of safety relevant components translated into
Portuguese.
23
Medical Device Registration
Brazil
 ANVISA (AGÊNCIA NACIONAL
DE VIGILÂNCIA SANITÁRIA)

n ANVISA established in 1999 under Brazil’s Ministry of

Health, is responsible for the regulation and oversight
of medical devices in Brazil. The regulation of medical
devices is through a series of resolutions or RDCs.
n Remote deposit capture RDC has long been known
as a system used strictly in the United States - but it's
gaining popularity elsewhere as various forms of
electronic settlement take hold around the world. Latin
America in particular stands poised to reap the
benefits of remote deposit, as banking reform
provides the opportunity to redefine the way cheques
and other payment instruments are handled.

25
REGULATIONS
n Resolution RDC No. 185 of October 22, 2001 is
the primary regulation applicable to the
registration of all medical devices, except for IVD
devices, which are covered by Resolution RDC
No. 206 of November 2006. RDC No. 185
describes the applicable device registration
protocol and lists the documents required to
legally register a medical device in Brazil.
Medical Device - Resolution RDC No. 185
IVD Device – Resolution RDC No. 206
26
 SCOPE AND CLASSIFICATION OF
DEVICES

n All medical devices are covered by Brazilian regulations but

a distinction is made according to Annex II of RDC No. 185.
n It describes the classification structure applicable to medical
devices, assigning medical devices to one of four risk
classes (I, II, III and IV) according to 18 different rules.
n The classification structure for medical devices in Brazil
corresponds to the system used in the European Union (EU)
under Council Directive 93/42/EEC.
n The classification rules for IVD devices follow the Global
Harmonisation Task Force (GHTF) classification rules.

I II III IV
27
 BRAZIL

n Brazil represents the largest medical device market in Latin America.

Brazil is one of the most recent Latin American countries to adopt
medical device regulation.
n Nevertheless, Brazil’s device approval process is notoriously lengthy
and submission costs are the most expensive in Latin America. Brazil’s
regulatory agency, ANVISA, generally employs a higher level of
scrutiny during the review process compared to other Latin American
countries.
n Device approval requires certification to Brazil’s Good Manufacturing
Practices (B-GMP, similar to FDA GMP), which can take up to 2 years
to obtain due to the enormous backlog in facility auditing. After device
approval, follow up B-GMP inspections are conducted every 2 years.
Recent regulation has established an abbreviated registration process
called “Cadastro” for lower risk devices, which permits circumvention of
GMP inspection.
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TECHNICAL DOCUMENTATION
n All devices must have technical documentation for the
safety and performance of the device showing compliance
with the Brazilian regulations. In addition, electro medical
devices must obtain INMETRO (ie the National Institute of
Metrology, Standardisation and Industrial Quality)
certification from a third-party certification body.
n Medical device manufacturers must have their products
tested by an Accredited Testing Laboratory (ILAC, EA or
IAAC). Test reports must be less than two years old and
cover the applicable standards described below:

29
n • NBR IEC 60601-1 series (The 60601-1 series specify
the General Requirements for safety of medical
equipment/system)
n • NBR 60601-2 series ( The 60601-2 series specify the
Particular Requirements for the basic safety and
performance of respective specific medical equipment)

n • NBR IEC 61689:1998: Ultrasonics – Physiotherapy

systems – Field specifications and methods of
measurement in the frequency range 0.5 MHz to 5 MHz

30
 IEC 60601-1 SERIES
n The 60601-1 series specify the General Requirements for
safety of medical equipment/system : .
IEC 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
FOR SAFETY 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR
EN 60601-1-1
MEDICAL ELECTRICAL SYSTEMS
IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC
EN 60601-1-2
COMPATIBILITY - REQUIREMENTS AND TESTS

IEC 60601-1-3 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS

FOR SAFETY - COLLATERAL STANDARD: GENERAL REQUIREMENTS FOR
EN 60601-1-3
RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT

IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT: PART 1-4: GENERAL REQUIREMENTS

FOR COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL
EN 60601-1-4
SYSTEMS
IEC 60601-1-6 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS
FOR SAFETY - COLLATERAL STANDARD: USABILITY
EN 60601-1-6
IEC 60601-1-8 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS
FOR SAFETY - COLLATERAL STANDARD:GENERAL REQUIREMENTS,
EN 60601-1-8
TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL
EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS

31
 IEC 60601-2 SERIES
n The 60601-2 series specify the Particular Requirements for
the basic safety and performance of respective specific
medical equipment and there are 52 reference standards of
the 60601-2 series being referred to with examples below: .
IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety
EN 60601-2-2 and essential performance of high frequency surgical equipment and high frequency
surgical accessories

IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety
EN 60601-2-10 and essential performance of nerve and muscle stimulators

IEC 60601-2-19 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety
EN 60601-2-19 and essential performance of infant incubators

IEC 60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety
EN 60601-2-27 and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-39 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
EN 60601-2-39 essential performance of peritoneal dialysis equipment

IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety
EN 60601-2-54 and essential performance of X-ray equipment for radiography and radioscopy

32
n • NBR ISO 6875:1998: Dental patient chair
n • NBR ISO 7785-1:1999: Dental handpieces – Part 1:
High-speed air turbine handpieces
n • NBR ISO 7785-2:2004: Dental handpieces – Part 2:
Straight and geared angle handpieces
n • NBR ISO 8835-2:2010: Inhalational anaesthesia systems
– Part 2: Anaesthetic breathing systems
n • NBR ISO 9680:2001: Dentistry – Operating lights
n • NBR ISO 9919:1997: Medical electrical equipment –
Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use
n • NBR ISO 11195:2000: Gas mixers for medical use –
Stand-alone gas mixers
33
Resolution RDC No. 27 and IN-3
n Consistent with the requirements of RDC No. 27, and IN-3
published in June 2011, all medical devices sold in Brazil
that fall under the scope of these standards must be
INMETRO certified.
n Importantly, under RDC No. 27 and IN-3, the third edition
of IEC 60601-1 is now acceptable in Brazil for INMETRO
certification. This is a significant change from RDC No. 32,
which omitted the third edition of IEC 60601-1 from the
Brazilian certification scheme.

34
QUALITY SYSTEMS (RDC No. 25)
n Good manufacturing practice (GMP) certification, based on
an inspection conducted by ANVISA, is required for
registration (RDC No. 25, May 21, 2009). The GMP
certificate must be submitted with the registration
application for all Class III and IV devices, as well as for
Class I and II devices noted on the Exemption List
(Instruction IN-2, June 6, 2011).
n GMP inspections are also required to revalidate or update
existing registrations. The GMP certificate is valid for two
years, and ANVISA determines whether subsequent
evaluations can be completed remotely through a
paperwork audit or another site inspection.

35
 QMS AUDIT AND INSPECTIONS

n In addition to an ANVISA inspection, where applicable, all

manufacturers who require INMETRO certification must
receive an annual factory inspection from a third party
certification body, some clauses similar to ISO 13485:2003.
n An auditor conducting a pre-licence inspection will also look
for evidence that the following production tests are being
performed by a manufacturer on 100% of medical devices
bearing the INMETRO mark:
• Leakage current (earth, enclosure, patient) (Clause 19 of
IEC 60601-1)
• Earthing (protective/functional and potential equalisation)
(Clause 18 of IEC 60601-1)
• Dielectric strength (Clause 20 of IEC 60601-1)
• Functional test

36
LOCAL DISTRIBUTORS, LICENCES AND REGISTRATION
n All foreign manufacturers must have a local distributor or
representative. All devices, with a few exceptions, must be
registered with ANVISA. Local manufacturers register
directly.

CURRENT AND FUTURE DEVELOPMENTS

n ANVISA plans to extend the number of foreign
manufacturers subject to audits.

37
Medical Device Registration
Canada
 HEALTH CANADA

n Health Canada, the Federal department

responsible for the Canadian Medical Devices
Regulations (MDR) and the Canadian Medical
Devices Conformity Assessment System
(CMDCAS), regulates all medical devices
manufactured or sold in Canada.

39
REGULATIONS
n Introduced in 2003, the Canadian MDR have not
undergone any significant changes and are now well
established.
n Medium and higher risk devices require third-party
certification and Health Canada, in collaboration
with the Standards Council of Canada (SCC),
developed the CMDCAS to support the MDR by
providing a framework to accredit CMDCAS
Recognised Registrars.
n CMDCAS Recognised Registrars perform Canadian
medical device certification audits and issue
CMDCAS Certificates against ISO 13485:2003.
40
 SCOPE AND
CLASSIFICATION OF DEVICES

n The Canadian MDR cover general medical devices,

active implantable medical devices and IVDs. All
medical devices receive classification into Class I, II,
III or IV. There is one set of rules for medical devices
and one set of rules for IVDs.
n The rules for medical devices are similar, but not
identical, to the rules in Annex IX of EC Directive
93/42/EEC. In addition, some products considered
medical devices in Canada fall outside the scope of
the European medical device directives (such as
Chinese herbs and medicine …)

I II III IV
41
 TECHNICAL DOCUMENTATION

n All manufacturers must have technical documentation or

a technical file showing the devices meet the Safety and
Effectiveness Requirements of the MDR. Although there
are differences between the Canadian Safety and
Effectiveness Requirements and the European Essential
Requirements, the technical documentation required is
in general similar to the requirements for CE marking.
n While testing to ISO and CAN product standards is not
usually mandatory, it is advisable for manufacturers to
adopt and test to recognised international standards.

42
QUALITY SYSTEMS
n Manufacturers of Class II, Class III and Class IV devices
must operate a QMS certified by a CMDCAS Recognised
Registrar to be in accordance with ISO 13485:2003 and
the requirements of the MDR.
n Own Brand Manufacturers are not exempt from the QMS
requirements. Manufacturers of Class II devices have the
option to exclude design from their QMS. CMDCAS
certification is required before making an application for a
Health Canada Licence.

43
LOCAL DISTRIBUTORS, LICENCES AND REGISTRATION
n Manufacturers exporting to Canada are not required to use local
authorised representatives (ARs). If used, distributors or importers need
to hold a medical device establishment licence (MDEL) from Health
Canada. The appointment and use of a Regulatory Correspondent is an
option for manufacturers outside of Canada in order to facilitate licence
applications and other regulatory functions.
n Manufacturers of Class II, III and IV devices must apply to Health
Canada and obtain a Medical Device Licence before placing any
products on the market. Applications need to be supported by the
CMDCAS certificate and varying levels of technical documentation
dependent on the class. Class I manufacturers only require the MDEL.
All current licences are shown on the Medical Devices Active Licence
Listing (MDALL).

44
 CURRENT AND
FUTURE DEVELOPMENTS

n The MDR is unlikely to be fundamentally changed in

the near future. However, Guidance Document GD
211, effective from January 1, 2012, imposes specific
requirements on the audit reports produced by
CMDCAS Recognised Registrars.
n Certified manufacturers will notice a changed and,
often, a more detailed report format as a
harmonisation process with US FDA.
n So far, the result is a pilot joint audit programme
(pMAP) and the acceptance of GD 211 compliant
CMDCAS audit reports under the FDA Voluntary Audit
Report Submission Pilot Program.

45
 Medical Device Registration
China

* This session is not covered in this lecture.

Medical Device Registration
Egypt
 MD REGULATION IN EGYPT

n The Egyptian Ministry of Health (MOH) is responsible for

the standardisation and co-ordination of the registration
and approval, and importation and manufacturing of
medical devices.

REGULATIONS
n Official regulations are currently being formulated and
have not yet been published.
n In practice, regulations based on the EC directives are
being implemented and all local or foreign manufacturers
must hold CE certificates or FDA registration.

48
SCOPE AND CLASSIFICATION OF DEVICES
n The scope and classification of devices is identical to the current
EC medical devices directives (ie Class I, IIa, IIb and III under
directive 93/42/EEC).

TECHNICAL DOCUMENTATION
n Technical documentation required to achieve CE marking is needed.

QUALITY SYSTEMS
n Local manufacturers of Class I devices require ISO 13485:2003
certification and local manufacturers of higher classes require ISO
13485:2003 and Annex II, V or VI to achieve CE marking. Foreign
manufacturers will require certification to achieve CE marking but
no direct Egyptian certification.

49
LOCAL DISTRIBUTORS, LICENCES AND REGISTRATION
n All foreign and local manufacturers must register devices with the
MOH based on existing CE marking. Foreign manufacturers can do
this directly or by Local Agent or Private Registrations Offices.

CURRENT AND FUTURE DEVELOPMENTS

n Local regulations are expected to be finalised in June 2013. At
present, all local manufacturers must hold a CE marking and ISO
13485 certificate. Failure to achieve or hold the required certification
prevents products from being sold in Egypt.

50
 Medical Device Registration
Europe
* This session is not covered in this lecture.
 Medical Device Registration
Hong Kong

* This session is covered by another lecture.

Medical Device Registration
Japan
 JAPAN

Regulatory Authority
n The Ministry of Health Labour and Welfare
(MHLW) is responsible for the Japanese
Pharmaceutical Affairs Law (JPAL) and
regulates all medical devices manufactured or
sold in Japan.

54
 MEDICAL DEVICE REGULATION

Regulations
n Since 2005, a revision of the Japanese Pharmaceutical
Affairs Law (JPAL), under the jurisdiction of the MHLW,
came into effect in order to bring regulations in-line with
global practices and ISO 13485:2003.
n The legislation established the Pharmaceutical and
Medical Devices Agency (PMDA) to undertake certain
technical tasks, and approved certain third parties as
Registered Certification Bodies (RCB). With the
exception of low risk Class I devices, all medical
devices products need regulatory approval.
55
 CLASSIFICATION OF MEDICAL DEVICES

SCOPE AND CLASSIFICATION OF DEVICES

n All medical devices and IVDs are covered and

are classified into three classes: Class I; Class II;
and Class III/IV. Some class II devices, which
have clearly established standards and essential
principles, have been defined as Designated
Controlled Medical Devices (DCMD).

I II III / IV

56
 TECHNICAL DOCUMENTATION

n Technical documentation must be submitted for

approval. It is mandatory for this documentation to
include evidence of compliance with approved
standards and essential principles via test reports;
and/or proof of equivalence to existing medical devices
in the Japanese market (“Me-too” programme).
n An RCB is responsible for the review of technical
documentation of DCMD; however, the review for
higher risk classes is undertaken by the PMDA.
n Class II DCMD – device review by RCB
n Class II, III/IV, device review by PMDA

57
QUALITY SYSTEMS
n The MHLW Ordinance #169 regulations define a
Japanese QMS, which except for some
additional requirements is in many respects
similar to ISO 13485:2003.
n With exception of certain low risk Class I device
manufacturers, all manufacturers require QMS
audits. For DCMD, these audits are undertaken
by an RCB, and for higher risk devices by the
PMDA.

58
 LOCAL DISTRIBUTORS,
LICENCES AND REGISTRATION

n All foreign manufacturers must appoint a licensed Market

Authorisation Holder (MAH) before they can consider
approval and selling in Japan. The MAH for foreign
manufacturers can either be a Japanese distributor, an
independent Japanese company or the Japanese
subsidiary of the manufacturer. The MAH must apply for
and obtain a device licence for all products before they
are placed on the market.
n Foreign manufacturing sites also need a business
licence (Accreditation) from the PMDA and this can be
granted by either document review or onsite inspection.

59
CURRENT AND FUTURE DEVELOPMENTS
n In 2005, there was 382 standards established for
the medical devices; however, the number has
now increased to 823 standards covering most
of the Class II medical devices based on
Japanese Medical Devices Nomenclature
(JMDN). It is proposed to increase the range of
medical devices that can be certified by RCBs in
the future.

60
Medical Device Registration
Korea (South Korea)
REGULATOR
n The regulatory authority in Korea is the Korean
Food and Drug Administration (KFDA), which is
an independent agency under the supervision of
the Ministry of Health and Welfare (MOHW).
REGULATIONS
n Since 2004, the Medical Devices Regulations
(MDR) have applied to medical devices.

62
 SCOPE AND CLASSIFICATION OF
MEDICAL DEVICES
n The MDR covers general medical devices, active
implantable medical devices and in-vitro diagnostic
(IVD) medical devices.
n All medical devices are classified into Class I, II, III
or IV; with one set of rules covering both medical
devices and IVDs.
n Classification has been determined by KFDA and
the rules for medical device classification are
different to the rules in Annex IX of EC Directive
93/42/EEC.

I II III IV
63
 TECHNICAL DOCUMENTATION

n All manufacturers must have technical

documentation showing the devices meet the
Safety and Effectiveness Requirements in the
MDR.
n ISO and Korea Standard (KS) product standards
are not usually mandatory but manufacturers are
advised to adopt where possible recognised
international standards.
n Medical devices can be categorised in three
ways: i) an equivalent product, ii) an improved
product, or iii) a new product according to
whether or not the device for approval is
substantially equivalent to another legally
marketed device product.
64
Equivalence Designated Device EDD
n If a medical device categorised as an
equivalent product is approved three (3) times
by a full technical file review, then the product
type and specification will be listed as an
‘equivalence designated device’ (EDD).
n Devices listed as such, will not be subject to full
review but only to a limited review and limited
testing at a KFDA approved laboratory.

65
 QUALITY SYSTEMS

n Domestic manufacturers of all classes of devices must operate a

QMS conforming to Korea Good Manufacturing Practice (KGMP)
which is similar to ISO 13485:2003
n An onsite GMP certificate will be required for all foreign
manufacturers of Class II, III and IV devices.
n Currently audits from a KFDA Recognised Registrar (one of four
Korean institutes) are required for distributors and importers.
n This is to be replaced by audits on foreign manufacturers. A KFDA
Recognised Registrar accompanied by a KFDA officer will carry
out all audits.
n KGMP/Onsite GMP certification must be renewed every three
years, while device licences and establishment licences are valid
permanently.

66
 LOCAL DISTRIBUTORS, LICENCES
AND REGISTRATION

n For all devices (Classes I-IV), it is a requirement to have a registered

distributor or importer in Korea
n Those that do operate need an Establishment Licence from KFDA.
n Before going on sale in Korea, Class II, III and IV devices need a
Device Licence from KFDA, and the application must be accompanied
by a KGMP/Onsite GMP certificate.
n The notification of Class I devices once registered with KFDA is
equivalent to a product licence. For Class II devices, the third party
(registered technical document review agency) may review the
technical files of certain designated Class II medical devices.
n KFDA deals with all procedures of approval for Class III and IV
devices, and all classes of IVDs

67
CURRENT AND FUTURE DEVELOPMENTS

n GMP audits are conducted on foreign

manufacturers on
- Class IV devices from 2012,
- Class III devices from 2013 and
- Class II devices from 2014.
n The list of manufacturers due for a three year
renewal are posted on the KFDA website.

68
Medical Device Registration
Saudi Arabia
n The Saudi Food and Drugs Authority (SFDA)
regulates all medical devices manufactured or
sold in the Kingdom of Saudi Arabia. The
SFDA is the national organisation that is
responsible for
(a) the Saudi Arabian Regulations (IR) IR=
Interim Regulations) and
(b) the Saudi Arabian Medical Devices
Marketing Authorisation System (MDMA).
IR will apply until the medical devices
comprehensive law is approved.
70
 REGULATIONS

n The SFDA was established as an independent Authority reporting

to the Council of Ministers and currently apply the Medical Devices
Interim Regulation, complemented by Implementing Rules, with
the requirement that only medical devices that have been
authorised by one of the Founding Members of the GHTF have
access to the Kingdom of SA (KSA) market.
n The interim regulatory scheme issued by the SFDA Board of
Directors comprises the Medical Devices Interim Regulation and
eight Implementing Rules adopted by the SFDA. (Medical Device
Sector MDS)
n The SFDA has appointed third party conformity assessment
bodies (CAB), but manufacturers and Authorised Representatives
(AR) do not communicate with them directly but with the SFDA.

71
 SCOPE AND CLASSIFICATION
OF MEDICAL DEVICES

n The SFDA system does not define a specific

classification scheme for medical devices. The system
requires that all devices must meet the requirements
of one of the GHTF member states registration (ie
Europe, USA, Canada, Australia or Japan) and the
respective classification required for the selected
member state.
n There are additional requirements stated in the
Interim Regulations and Implementing Rules that
cover issues specific to local conditions (eg Power
Supply Requirements and Local Environmental
Conditions, etc).

72
TECHNICAL DOCUMENTATION
n All manufacturers must have technical documentation
or a technical file showing the devices meet the
Safety and Effectiveness Requirements in accordance
with the requirements of the GHTF member state the
manufacturer has selected to apply for product
licensing.
n The SFDA requires the location of the technical
documentation/file to be stated in case of a need to
conduct a review based on issues seen within the
market.

73
QUALITY SYSTEMS
n Manufacturers must operate a QMS that conforms to the
requirements of the GHTF member state selected (ie for
CE marked product (Non Class 1) ISO13485).
LOCAL DISTRIBUTORS, LICENCES AND
REGISTRATION
n Manufacturers exporting to the Kingdom of Saudi Arabia
are required to use local ARs. The AR should be licensed
in accordance with MDS – IR5 implementing rule on
licensing of ARs. The manufacturers AR must apply for
product licensing through the Medical Devices National
Registry (MDNR).
74
CURRENT AND FUTURE DEVELOPMENTS
n The Interim Regulations and associated regulations will be
amended and updated to SFDA Regulations as part of a
medium term implementation plan; however, there are no
stated timeframes for this.
n Starting in October 2012 until 2014, the SFDA will be
enforcing a staged port closure to devices without a
MDMA licence. This will be a multi-stage implementation
based on device type/class over one to two years and is
aimed at ensuring that all medical devices exported are
appropriately authorised.

75
Medical Device Registration
Singapore
 REGULATORY

n The Medical Device Branch of the Health

Science Authority (HSA) is responsible for a
range of assessment and monitoring
activities that ensure medical devices
available in Singapore meet standards in
accordance to the Health Products Act and
Health Products (Medical Devices)
Regulations.

77
REGULATIONS
n In 2002, the implementation of the Voluntary
Product Registration Scheme lead HSA to
undertake an active post market monitoring and
surveillance programme for medical devices.
n With the Health Products Act of 2007, HSA has
now implemented the Health Products (Medical
Devices) Regulations to better regulate medical
devices in Singapore.

78
 REGISTER OF MEDICAL DEVICE
MANUFACTURERS LICENCE
HOLDERS

n Since August 10, 2010, any company that

manufactures finished medical devices in Singapore
is required to obtain a manufacturer’s licence from
HSA. Certification to ISO 13485 is one of the pre-
requisites for the manufacturer’s licence.
n From 2010, there have been a series of HSA
regulations expanding and changing the registration
requirements mainly for imported devices:
n Import and Supply Control (with effect from
November 1, 2007)

79
 IMPORT AND
SUPPLY CONTROL

Mandatory duties and obligations that all dealers of medical devices

must fulfil: (with effect from November 1, 2007)
n • Duty to maintain records of import and supply
n • Duty to maintain records of complaints
n • Reporting of defects and adverse effects to HSA
n • Notification to HSA concerning field safety correction actions (eg
recall)
n • Prohibition against false or misleading advertisement

Import and Supply Control (with effect from August 10, 2010)
n Only licensed dealers are allowed to manufacture, import or
wholesale medical devices (regardless of the risk classification of
the medical devices).

80
 IMPORT AND SUPPLY CONTROL

Import and Supply Control (with effect from January 1, 2012)

n All medical devices regardless of risk classification (unless
exempted from product registration), including medical devices
that are licensable under the Radiation Protection Act (Cap. 262)
by the Centre for Radiation Protection and Nuclear Science
(CRPNS) of the National Environment Agency (NEA), imported
and supplied must meet one of the criteria below:
• Listed on the Singapore Medical Device Register (SMDR)
• Listed on the Transition List
• Authorised via one of the Authorisation Routes

81
Enhancements to the regulatory system for Class A medical devices
n Since May 1, 2012, all Class A medical devices, except sterile Class
A medical devices, are exempt from product registration. Dealers
manufacturing and importing products that are exempted from
product registration will, however, be required to declare the list of
such products in the importer’s and manufacturer’s licences and
update the list every half-yearly
Enhancements to the regulatory system for Class B medical devices
n Since September 1, 2012, HSA has a new Immediate Registration
route for Class B medical devices to allow immediate access to
medical devices that have already been approved by at least two of
HSA’s independent reference regulatory agencies (ie US FDA,
EU/TGA, Health Canada, Japan MHLW) and marketed for at least
three years without safety concerns. .

82
 EXPEDITED REGISTRATION ROUTE

HSA is also creating an Expedited Registration route, with a

turnaround time of 60 working days excluding stop-clock.
Product registration applications will qualify for this new
route if the medical device meets one of the following
criteria:
1. Approval by at least two of HSA’s independent
reference regulatory agencies
OR
2. Approval by one of HSA’s independent reference
regulatory agencies and marketed in Singapore or that
reference agency’s jurisdiction for at least three years
without safety concerns

83
Special Authorisation Routes
n All special authorisation licences (GN-27, GN-28, GN-29,
GN-30(CUR), GN-30(CR)) that have been submitted from
March 1, 2012, onwards will have a validity period of 12
months for importation. Guidance is currently in the
process of revision to reflect this requirement.
n For the importation of unregistered medical devices for
exhibition purposes, the importing party shall seek
authorisation from HSA prior to importing the specific
consignment.

84
SCOPE AND CLASSIFICATION OF DEVICES
n Currently, there are four classes (ie A, B, C, and D) for medical
devices in Singapore. The classification rules for medical devices
are available in GN-13: ‘Guidance on the risk classification of
general medical device’ which is based on the GHTF
classification rules.

A B C D

QUALITY SYSTEMS
n In order to apply for the establishment licence-manufacturer, all
local manufacturers of all classes of devices must operate a QMS
conforming to ISO 13485 or its equivalent.
85
 TECHNICAL DOCUMENTATION

n Only product registration is required for Singapore,

and submission of full technical documentation is not
required. Product registration applications for medical
devices submitted to HSA must be prepared in the
format set out in the Association of Southeast Asian
Nations (ASEAN) Common Submission Dossier
Template (CSDT) documents
n GN17: ‘Guidance on Preparation of Product
Registration Submission for General Medical Devices
using the ASEAN CSDT’ and
n GN18: ‘Guidance on Preparation of a Product
Registration Submission for In Vitro Diagnostic (IVD)
Medical Devices using the ASEAN CSDT’).
86
LOCAL DISTRIBUTORS, LICENCES AND REGISTRATION
n For all Classes (A, B, C and D) of devices, in order to apply for the
establishment licence (ie importer and wholesaler) the companies
have to be audited and certified against the Good Distribution
Practices of Medical Devices Scheme (GDPMDS), TS-01. Foreign
manufacturers must register devices via a local importer.
FUTURE DEVELOPMENTS
n As part of efforts to enhance economic integration among ASEAN
member states, ASEAN has been working on developing a
standardised framework for regulating medical devices. This draft set
of broad principles, targeted for implementation by December 2014,
is called the ASEAN Medical Devices Directive (AMDD) and it is now
ready for industry consultation. In Singapore, several aspects of the
AMDD have been incorporated into legislation as part of the
Singapore Health Products Act, including risk classification and post-
market surveillance systems.
87
 Medical Device Registration
Taiwan

* This session is not covered in this lecture.

 Medical Device Registration
USA
* This session is not covered in this lecture.
Medical Device Registration
- African Member States
 AFRICAN COUNTRIES

n The African Economic Community (AEC) is an organization of

African Union states establishing grounds for mutual economic
development among the majority of African states.
n For regulation of medical devices, whilst individual African States
might have respective regulation in different forms and at different
times, the formal alignment of MD regulation started with EAC in
July 2012 with consultative meetings and in Dec 2012 through the
formation of Pan African Harmonization Working Party (PAHWP)
n PAHWP is a voluntary body that aims to improve access to safe
and affordable medical devices and diagnostics in Africa though
harmonized regulation.
n Current priority is in vitro diagnostic devices
n PAHWP started with 5 EAC Member States, and has grown to over
20 African countries in 2015.
91
EAC
The East African Community (EAC) is
the regional intergovernmental
organisation of the Republics of Kenya,
Uganda, the United Republic of
Tanzania, Republic of Burundi and
Republic of Rwanda with its
headquarters in Arusha, Tanzania.

The Treaty for Establishment of the

EAC was signed on 30th November
1999 and entered into force on 7th July
2000.

92
Characteristics of African Market
n Mainly an IVD or medical diagnostics, POC and rapid tests
n Laboratory verification and performance tests
n African Society of Laboratory Medicine (ASLM)
n Countries are of scarce resource
n Highly rely on donation activities vs regulation control
n WHO assisted pre-qualification tests
n Lack of regulatory knowhow, expertise and personnel;
n Lack of government regulatory hierarchy for medical
device and ivds.
n Lack of transparency in regulation framework for Medical
Device and ivds. …
93
 CALENDAR OF MAJOR ACTIVITIES

n July 2012 Stakeholders meeting in Narobi, Kenya;

n Oct 2012 Publish survey report on EAC member states
n July 2013 First African Regulatory Forum (ARF) in
– To establish a TC with Technical Working Groups (TWG)
n Sept 2013 Joint Conference with WG2, AHWP
n Jan 2014 Second ARF
n Nov 2014 Third ARF
n No update for 2015

94
96
East African baseline study published in
BMC Health Services Research

http://www.biomedcentral.com/1472-6963/14/524
98
 1ST AFRICAN REGULATORY FORUM

n First African Regulatory Forum, 31 July 2013, Nairobi, Kenya

99
 PAHWP HARMONIZATION

n Common Definition and risk classification rules

GHTF risk-based classification (A, B, C and D)
n Common registration file (WHO Pre-qualification
Format)
n Auditing Quality System (ISO 13485)
n Clinical Evidence
n Post-market

100
STRUCTURE FOR PAN AFRICAN HARMONIZATION WORKING
PARTY (PAHWP) FOR MEDICAL DEVICES & DIAGNOSTICS

African Regulatory
Harmonization Advisory
Committee for
medicines, medical
EAC Process:
devices & diagnostics
Sectoral Committee,
Council of Ministers,
Summit
African Medicines African Medicines
Pan African
Regulatory Regulatory
EAC Project Steering Harmonization working
Harmonization(AMRH) Harmonization(AMRH)
Committee party for medical
TWG Medicines Policy TWG on Regulatory
devices & diagnostics
& Regulatory Reforms Capacity Development

TWG Registration &

TWG Quality Audit & TWG Clinical TWG Post-Market
Common Submission Subgroups… Subgroups...
Inspection Performance Studies Surveillance
Dossier
The African Regulatory Forums offer opportunities for
n Steering Committee to plan for overall directions;
n TWGs - Technical discussion and strategies for different
regulatory issues on IVD
n Sharing of progress on regulation harmonization items
n Sharing of updated knowledge with and from developed
countries
n Opportunity for Training and Capacity Building
n Identify and establish links for international exposure
(1) Cooperation with IVD Premarket WG of AHWP (2) Join
AHWP as Member economy (3) Attend ISO TC 212

102
 JOINT CONFERENCE ON IVD

n Joint Conference on IVD with WG2, AHWP in Sept 2013 in Taipei

103
Medical Device Registration –
Global Review
End