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This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <https://www.tga.gov.au/treatment-information-provided-tga>.

Medical devices Essential Principles checklist

Manufacturer name

Product name

ID

Notes on what to include in each column

Applicable/Not applicable – respond with ‘A’ or ‘NA’ for the device. If not applicable (NA) include justification.
Medical Device Standards applied by manufacturer - only include standards published by the TGA as Medical Device Standard Orders or Conformity
Assessment Standard Order.
Other standards or procedures applied by manufacturer – include; EN, ISO, international or local standards or company procedures identified by number or
title.
Evidence of compliance or reason for non-applicability – include direct reference to documents such as: study results, test reports, design outputs identified
by number or title within the Quality System.
Note: Therapeutic Goods Act 1989 (the Act) and Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

PO Box 100 Woden ACT 2606 ABN 40 939 406 804

Phone: 1800 020 653 Fax: 02 6203 1605 Email: info@tga.gov.au https://www.tga.gov.au
Reference/Publication #
 Schedule Essential Principle from the Regulations Applicable/ Medical Device Other standards or Evidence of compliance or
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applicable manufacturer manufacturer applicability

Part 1. General principles

Use of medical devices not to compromise health and

1. safety
A medical device is to be designed and produced in a way that
ensures that:
(a) the device will not compromise the clinical condition or safety
of a patient, or the safety and health of the user of any other
person, when the device is used on a patient under the
conditions and for the purposes for which the device was
intended and, if applicable, by a user with appropriate
technical knowledge, experience, education or training; and
(b) any risks associated with the use of the device are:
(i) acceptable risks when weighed against the intended
benefit to the patient; and
(ii) compatible with a high level of protection of health and
safety.
Design and construction of medical devices to conform with
2. safety principles
(1) The solutions adopted by the manufacturer for the design
and construction of a medical device must conform with
safety principles, having regard to the generally
acknowledged state of the art.
(2) Without limiting subclause (1), in selecting appropriate
solutions for the design and construction of a medical device
so as to minimise any risks associated with the use of the
device, the manufacturer must:
(a) first, identify hazards and associated risks arising from
the use of the device for its intended purpose, and
foreseeable misuse of the device; and
(b) second, eliminate, or reduce, these risks as far as
possible by adopting a policy of inherently safe design
and construction; and
(c) third, if appropriate, ensure that adequate protection
measures are taken, including alarms if necessary, in
relation to any risks that cannot be eliminated; and
d) fourth, inform users of any residual risks that may arise
due to any shortcomings of the protection measures
adopted.
(3) In paragraph (2) (d):
residual risk, for a medical device, means the risk remaining
after the measures described in paragraphs (2) (a), (b) and
(c) have been applied.

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Medical devices to be suitable for intended purpose

3. A medical device must:
(a) perform in the way intended by the manufacturer; and
(b) be designed, produced and packaged in a way that ensures
that it is suitable for one or more of the purposes mentioned
in the definition of medical device in subsection 41BD(1) of
the Act.
Long-term safety
4. A medical device must be designed and produced in a way that
ensures that if:
(a) the device is used within the period, indicated by the
manufacturer, in which the device can be safely used; and
(b) the device is not subjected to stresses that are outside the
stresses that can occur during normal conditions of use; and
(c) the device is regularly maintained and calibrated in
accordance with the manufacturer’s instructions;
the characteristics and performances mentioned in clauses 1, 2
and 3 are not adversely affected.
Medical devices not to be adversely affected by transport or
5. storage
A medical device must be designed, produced and packed in a
way that ensures that the characteristics and performance of the
device when it is being used for its intended purpose will not be
adversely affected during transport and storage that is carried
out taking account of the instructions and information provided
by the manufacturer.
Benefits of medical devices to outweigh any undesirable
6. effects
The benefits to be gained from the use of a medical device for
the performance intended by the manufacturer must outweigh
any undesirable effects arising from its use.
These clause numbers are in Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)

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Part 2. Principles about design and construction

7. Chemical, physical and biological properties

Choice of materials
7.1 In ensuring that the requirements of Part 1 are met in relation to
a medical device, particular attention must be given to:
(a) the chemical and physical properties of the materials used in
the device; and
(b) the compatibility between the materials used and biological
tissues, cells, body fluids and specimens;
having regard to the intended purpose of the device.
Minimisation of risks associated with contaminants and
7.2 residues
(1) A medical device must be designed, produced and packed in
a way that ensures that any risks associated with
contaminants and residues that may affect a person who is
involved in transporting, storing or using the device, or a
patient, are minimised, having regard to the intended
purpose of the device.
(2) In minimising risks, particular consideration must be given to
the likely duration and frequency of any tissue exposure
associated with the transportation, storage or use of the
device.
Ability to be used safely with materials etc
7.3 (1) A medical device must be designed and produced in a way
that ensures that the device can be used safely with any
material, substance or gas with which the device may come
into contact during normal use or use in routine procedures.
(2) If the device is intended to be used to administer medicine, it
must be designed and produced in a way that ensures that
the device:
(a) is compatible with the provisions and restrictions applying
to the medicine to be administered; and
(b) allows the medicine to perform as intended.
Verification of incorporated substance
7.4 (1) If a medical device incorporates, or is intended to
incorporate, as an integral part, a substance that, if used
separately, might be considered to be a medicine that is
intended to act on a patient in a way that is ancillary to the
device:

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(a) the safety and quality of the substance must be verified in
7.4 accordance with the requirements for medicines; and
(b) the ancillary action of the substance must be verified
having regard to the intended purpose of the device.
(2) For the purposes of this clause, any stable derivative of
human blood or human plasma is considered to be a
medicine.
Minimisation of risks associated with leaching substances
7.5 A medical device must be designed and produced in a way that
ensures that any risks associated with substances that may
leach from the device are minimised.
Minimisation of risks associated with ingress or egress of
7.6 substances
A medical device must be designed and produced in a way that
ensures that any risks associated with unintentional ingress of
substances into, or unintentional egress of substances out of,
the device are minimised, having regard to the nature of the
environment in which the device is intended to be used.
Minimisation of risks associated with nanomaterials
7.7 (1) A medical device must be designed and produced in a way
that ensures that any risks associated with the size and the
properties of particles which are, or can be, released into a
patient’s or user’s body are minimised.
(2) In minimising risks, particular attention must be given to the
use of nanomaterials.
(3) Subclause (1) does not apply to particles that come into
contact with intact skin only.
8. Infection and microbial contamination
Minimisation of risk of infection and contamination
8.1 (1) A medical device must be designed and produced in a way
that ensures that the risk of infection to a patient, a user, or
any other person, is eliminated or minimised.
(2) The device must be designed in a way that:
(a) allows it to be easily handled; and
(b) if appropriate, minimises contamination of the device or
specimen by the patient, user or other person; and
(c) if appropriate, minimises contamination of the patient,
user or other person by the device or specimen.

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Part 2. Principles about design and construction

Control of animal, microbial or recombinant tissues, tissue
8.2 derivatives, cells and other substances
(1) This clause applies in relation to a medical device that
contains:
(a) tissues, tissue derivatives, cells or substances or animal
origin that have been rendered non-viable; and
(b) tissues, tissue derivatives, cells or substances of
microbial or recombinant origin.
(2) If the tissues, tissue derivatives, cells or substances
originated from animals, the animals must have been
subjected to appropriate veterinary controls and supervision,
having regard to the intended use of the tissues, tissue
derivatives, cells or substances.
(3) If the medical device contains tissues, tissue derivatives,
cells or substances of animal origin, a record must be kept of
the country of origin of each animal from which the tissues,
tissue derivatives, cells or substances originated.
(4) The processing, preservation, testing and handling of tissues,
tissue derivatives, cells or substances of animal, microbial or
recombinant origin must be carried out in a way that ensures
the highest standards of safety for a patient, the user of the
device, and any other person.
(5) In particular, the production process must implement
validated methods of elimination, or inactivation, in relation to
viruses and other transmissible agents.
Note: This may not apply to certain IVD medical devices if the
characteristics mentioned in subclause 8.2(5) are integral to the
intended purpose of the IVD medical device.
Medical devices to be supplied in a sterile state
8.3 (1) This clause applies in relation to a medical device that is
intended by the manufacturer to be supplied in a sterile state.
(2) The device must be designed, produced and packed in a way
that ensures that the device is sterile when it is supplied, and
will remain sterile, if stored and transported in accordance
with the directions of the manufacturer, until the protective
packaging is opened or damaged.
(3) The device must be produced and sterilised using an
appropriate validated method.
(4) The device must be produced in appropriately controlled
conditions.

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Medical devices to be supplied in a non-sterile state
8.4 (1) A medical device that is intended by the manufacturer to be
supplied in a non-sterile state must be packed in a way that
ensures that the device maintains the level of cleanliness
stipulated by the manufacturer.
(2) If the device is intended to be sterilised before it is used, the
device must be packed in a way that:
(a) ensures that the risk of microbial contamination is
minimised; and
(b) is suitable, having regard to the method of sterilisation
that the manufacturer indicates is to be used for the
device.
(3) The device must be produced in appropriately controlled
conditions
Distinction between medical devices supplied in sterile and
8.5 non-sterile state
If a medical device is supplied in both a sterile state and a non-
sterile state, the information provided with the device must
clearly indicate whether the device is in a sterile state or a non-
sterile state.
9. Construction and environmental properties
Medical devices intended to be used in combination with
9.1 other devices or equipment
A medical device that is intended by the manufacturer to be
used in combination with another medical device or other
equipment (including a connection system) must be designed
and produced in a way that ensures that:
(a) the medical device, and any other device or equipment with
which it is used, operate in a safe way; and
(b) the intended performance of the device, and any other device
or equipment with which it is used, is not impaired.
Minimisation of risks associated with use of medical
9.2 devices
A medical device must be designed and produced in a way that
ensures that, as far as practicable, the following risks are
removed or minimised:
(a) the risk of injury arising from the physical features of the
device;
(b) any risks associated with reasonably foreseeable
environmental conditions;

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(c) the risk of reciprocal interference involving other devices that
are normally used in an investigation or treatment of the kind
for which the device is intended to be used;
(d) any risks arising if maintenance or calibration of the device is
not possible;
(e) any risks associated with the ageing of materials used in the
device;
(f) any risks associated with the loss of accuracy of any
measuring or control mechanism of the device;
(g) the risk of fire or explosion occurring during normal use of the
device, and in the event of a single fault condition, especially
if the device is intended to be exposed to flammable
substances or substances that can cause combustion;
(h) the risks associated with disposal of any waste substances.
10. Medical devices with a measuring function
(1) A medical device that has a measuring function must be
designed and produced in a way that ensures that the device
provides accurate, precise and stable measurements within
the limits indicated by the manufacturer and having regard to
the intended purpose of the device.
(2) The measurement, monitoring and display scale of the
device must be designed and produced in accordance with
ergonomic principles, having regard to the intended purpose
of the device.
(3) The measurements made by the device must be expressed:
(a) in Australian legal units of measurement; or
(b) if the device measures a physical quantity for which no
Australian legal unit of measurement has been prescribed
under the National Measurement Act 1960, in units
approved by the Secretary for the particular device.
11. Protection against radiation

Minimisation of exposure to radiation

11.1 A medical device must be designed and produced in a way that
ensures that the exposure of a patient, the user, or any other
person, to radiation is minimised, having regard to the levels of
radiation required to enable the device to perform its therapeutic
and diagnostic functions and the intended purpose of the device.

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Medical devices intended to emit radiation

11.2 (1) This clause applies in relation to a medical device that is
intended by a manufacturer to emit hazardous levels of
visible or invisible radiation because the emission is
necessary for a specific medical purpose, the benefit of
which is considered to outweigh the risks inherent in the
emission.
(2) The device must be designed and produced in a way that
ensures that the user can control the level of the emission.
(3) The device must be designed and produced in a way that
ensures the reproducibility and tolerance of relevant variable
parameters.
(4) If practicable, the device must be fitted with a visual indicator
or an audible warning, or both, that operates if potentially
hazardous levels of radiation are emitted.
Minimisation of exposure to unintended radiation
11.3 A medical device must be designed and produced in a way that
ensures that the exposure of a patient, the user, or any other
person, to the emission of unintended, stray or scattered
radiation is minimised.
Operating instructions
11.4 The operating instructions for a medical device that emits
radiation must include detailed information about the following
matters:
(a) the nature of the radiation emitted;
(b) the means by which patients and users can be protected
from the radiation;
(c) ways to avoid misusing the device;
(d) ways to eliminate any risks inherent in the installation of the
device.
Medical devices intended to emit ionising radiation –
11.5 additional requirements
(1) This clause applies, in addition to clauses 11.1 to 11.4, in
relation to a medical device that is intended by the
manufacturer to emit ionising radiation.
(2) The device must be designed and produced in a way that
ensures that, if practicable, the quantity, geometry and
energy distribution (or quality) of radiation emitted can be
controlled and varied, having regard to the intended purpose
of the device.

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(3) If the device is intended to be used for diagnostic radiology,

the device must be designed and produced in a way that
ensures that, when used in relation to a patient for a purpose
intended by the manufacturer;
(a) the device achieves an appropriate image or output
quality for that purpose; and
(b) the exposure of the patient, or the user, to radiation is
minimised.
(4) If the device is intended to be used for therapeutic radiology,
the device must be designed and produced in a way that
ensures that the delivered dose of radiation, the type and
energy of the radiation beam, and, if appropriate, the energy
distribution of the radiation beam, can be reliably controlled
and monitored.
12. Medical devices connected to or equipped with an energy
source
Programmed or programmable medical device or software
12.1 that is a medical device
(1) A programmed or programmable medical device, or software
that is a medical device, that is intended to make use of
either or both of data and information must be designed and
produced in a way that ensures that:
(a) the safety, performance, reliability, accuracy, precision,
useability, security and repeatability of the device are
appropriate for the intended purpose of the device; and
(b) any consequent risks, or impairment of performance,
associated with one or more fault conditions is eliminated
or appropriately reduced; and
(c) the device is resilient with respect to interactions that
could occur during the use of the device and that could
result in unsafe performance of the device; and
(d) if relevant to the safety of a patient, or the safety and
health of the user or any other person, the device
provides suitable warnings in a timely manner:
(i) following the disruption to services upon which the device
is dependent for the device’s operation; and
(ii) following the performance of the device being adversely
affected; and
(e) if relevant to the safety of a patient, or the safety and
health of the user or any other person, the device
provides a means by which the user can verify correct
operation of the device; and

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(f) if relevant to the safety of a patient, or the safety and

health of the user or any other person, the integrity and
quality of the data or information is maintained; and
(g) if relevant, the privacy of the data or information is
maintained.
(2) A programmed or programmable medical device, or software
that is a medical device, must be developed, produced and
maintained having regard to the generally acknowledged
state of the art (including for design, development life cycle,
development environment, version control, quality and risk
management, security, verification and validation, change
and configuration management and problem resolution).
(3) A programmed or programmable medical device, or software
that is a medical device, that is intended to be used in
combination with computing platforms must be designed and
developed taking into account the capability, resources and
configuration of the platforms and the external factors
(including information technology environments) related to
the use of the platforms.
(4) The manufacturer of a programmed or programmable
medical device, or software that is a medical device, must
provide instructions or information with the device that sets
out requirements (including requirements about hardware,
software, information technology environments and security
measures) necessary to operate the device as intended.
(5) A programmed or programmable medical device, or software
that is a medical device, must be designed, produced and
maintained with regard to best practice in relation to
software, security and engineering to provide cybersecurity
of the device, including where appropriate the following:
(a) protection against unauthorised access, unauthorised
influence or unauthorised manipulation;
(b) minimisation of risks associated with known cybersecurity
vulnerabilities (including either or both of remediation of
known vulnerabilities and application of compensating
controls);
(c) facilitation of the application of updates, patches,
compensating controls and other improvements;
(d) disclosure of known vulnerabilities in the device or its
components and associated mitigations;
(e) making available sufficient information for a user to make
decisions with respect to the safety of applying, or not
applying, updates, patches, compensating controls and
other improvements
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6) The manufacturer of a programmed or programmable medical

device, or software that is a medical device, having regard to
the intended purpose of the device, the generally
acknowledged state of the art and best practice, must ensure
that the data that influences the performance of the device is:
(a) representative; and
(b) of sufficient quality; and
(c) maintained to ensure integrity; and
(d) managed to reduce bias.
Safety dependent on internal power supply
12.2 (1) This clause applies in relation to a medical device if the
safety of a patient on whom the device is to be used will
depend on an internal power supply for the device.
(2) The device must be fitted with a means of determining the
state of the power supply.
Safety dependent on external power supply
12.3 (1) This clause applies in relation to a medical device if the
safety of a patient on whom the device is to be used will
depend on an external power supply for the device.
(2) The device must be fitted with an alarm system that indicates
whether a power failure has occurred.
Medical devices intended to monitor clinical parameters
12.4 A medical device that is intended by the manufacturer to be
used to monitor one or more clinical parameters of a patient
must be fitted with an appropriate alarm system to warn the user
if a situation has developed that could lead to the death of the
patient or a severe deterioration in the state of the patient’s
health
Minimisation of risk of electromagnetic fields
12.5 A medical device must be designed and produced in a way that
ensures that the risk of an electromagnetic field being created
that could impair the operation of other devices or equipment
being used in the vicinity of the medical device is minimised.
Protection against electrical risks
12.6 A medical device must be designed and produced in a way that
ensures that, as far as possible, when the device is installed
correctly, and the device is being used for an intended purpose
under normal conditions of use and in the event of a single fault
condition, patients, users, and any other persons, are protected
against the risk of accidental electric shock.

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Protection against mechanical risks

12.7 A medical device must be designed and produced in a way that
ensures that a patient, the users and any other person, is
protected against any mechanical risks associated with the use
of the device.
Protection against risks associated with vibration
12.8 (1) A medical device must be designed and produced in a way
that ensures that any risks associated with vibrations
generated by the device are minimised.
(2) If vibrations are not part of the intended performance of the
device, particular attention must be given to relevant
technical progress, and the available means, for limiting
vibrations, particularly at source.
Protection against risks associated with noise
12.9 (1) A medical device must be designed and produced in a way
that ensures that any risks associated with noise emitted by
the device are minimised.
(2) If noise is not part of the intended performance of the device,
particular attention must be given to relevant technical
progress, and the available means, for reducing the emission
of noise, particularly at source.
Protection against risks associated with terminals and
12.10 connectors
A medical device that is intended by the manufacturer to be
connected to an electric, gas, hydraulic, pneumatic or other
energy supply must be designed and produced in a way that
ensures that any risks to the user associated with the handling of
a terminal or connector on the device, in relation to the energy
supply are minimised.
Protection against risks associated with heat
12.11 A medical device must be designed and produced in a way that
ensures that, during normal use, any accessible part of the
device (other than any part intended by the manufacturer to
supply heat or reach a given temperature), and any area
surrounding an accessible part of the device, does not reach a
potentially dangerous temperature.
Protection against risks associated with administration of
12.12 energy or substances
(1) This clause applies in relation to a medical device that is
intended by the manufacturer to be used to administer
energy or a substance to a patient.

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(2) The device must be designed and produced in a way that
ensures that:
(a) the delivered rate and amount of energy or of the
substance can be set and maintained accurately to
ensure the safety of the patient and the user; and
(b) as far as possible, the accidental release of dangerous
levels of energy or of the substance is prevented.
(3) the device must be fitted with a means of indicating or, if
appropriate, preventing inadequacies in the rate and amount
of energy or of the substance administered that might cause
danger to the patient, the user or any other person.
(4) The functions of each control and indicator on the device
must be clearly specified on the device.
(5) If the instructions for the operation of the device, or the
operating or adjustment parameters for the device, are
displayed by means of a visual system incorporated into the
device, the instructions or parameters must be able to be
understood by the user and, if appropriate, the patient.
Active implantable medical devices
12.13 (1) An active implantable medical device must incorporate,
display, emit or exhibit a code or unique characteristic that
can be used to identify:
(a) the type of device; and
(b) the manufacturer of the device; and
(c) the year of manufacture of the device.
(2) the code or unique characteristic must be able to be read
without the need for surgery to the person in whom the
device is implanted.
13. Information supplied by the manufacturer
Information to be provided with medical devices – general
13.1 (1) The following information must be provided with a medical
device:
(a) information identifying the device;
(b) information identifying the manufacturer of the device;
(c) information explaining how to use the device safely,
having regard to the training and knowledge of potential
users of the device.
(2) In particular:
(a) the information required by clause 13.3 must be provided
with a medical device; and

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(b) if instructions for use of the device are required under
subclause 13.4, the information mentioned in subclause
13.4(3) must be provided in those instructions.
(3) The information:
(a) must be provided in English; and
(b) may also be provided in any other language.
(4) The format, content and location of the information must be
appropriate for the device and its intended purpose.
(5) Any number, letter, symbol, or letter or number in a symbol,
used in the information must be legible and at least
1 millimetre high.
(6) If a symbol or identification colour that is not included in a
medical device standard is used in the information provided with
the device, or in the instructions for use of the device, the
meaning of the symbol or identification colour must be explained
in the information provided with the device or the instructions for
use of the device
Information to be provided with medical devices – location
13.2 (1) Unless it is impracticable and inappropriate to do so, the
information required to be provided with a medical device
must be provided on the device itself.
(2) If it is not practicable to comply with subclause (1) in relation
to the provision of the information, the information must be
provided:
(a) on the packaging used for the device; or
(b) in the case of devices that are packaged together
because individual packaging of the devices is not
practicable – on the outer packaging used for the
devices.
(3) If it is not practicable to comply with subclause (1) or (2) in
relation to the provision of the information required under
subregulation 10.2(1) or clause 13.3:
(a) for a medical device that is not software—the information
must be provided on a leaflet supplied with the device; or
(b) for a medical device that is software—the information
must be provided on a leaflet supplied with the device or
the information must be provided electronically.
(4) If it is not practicable to comply with subclause (1) or (2) in
relation to the provision of the information under clause 13.4,
the information must be provided in printed documents or
other appropriate media.

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Information to be provided with medical devices – particular
13.3 requirements
The information mentioned below must be provided with a
medical device.
(1) The manufacturer’s name, or trade name, and address
(2) The intended purpose of the device, the intended user of the
device, and the kind of patient on whom the device is
intended to be used where these are not obvious
(3) Sufficient information to enable a user to identify the device,
or if relevant, the contents of packaging
(4) Any particular handling or storage requirements applying to
the device
(5) Any warnings, restrictions on use, or precautions that should
be taken, in relation to the use of the device
(6) Any special operating instructions for the use of the device
(7) If applicable, an indication that the device is intended for a
single use only
(8) If applicable, an indication that the device has been custom-
made for a particular individual or health professional and is
intended for use only by that individual or health professional
(9) If applicable, an indication that:
(a) if the device is a medical device other than an IVD
medical device – the device is intended for pre-market
clinical investigation; or
(b) if the device is an IVD medical device – the device is
intended for performance evaluation only
(10) For a sterile device, the word “STERILE” and information
about the method that was used to sterilise the device
(11) The batch code, lot number or serial number of the device.
(12) If applicable, a statement of the date (expressed in a way
that clearly identifies the month and year) up to when the
device can be safely used
(13) If the information provided with the device does not include
the information mentioned in item 12 – a statement of the
date of manufacture of the device (this may be included in
the batch code, lot number or serial number of the device
provided the date is clearly identifiable)
(14) If applicable, the words “for export only”
Note: In addition to the information mentioned above, regulation
10.2 requires certain information to be provided with a medical
device

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Instructions for use
13.4 (1) Instructions for the use of a medical device must be provided
with the device.
(2) However, instructions for use of a medical device need not
be provided with the device, or may be abbreviated, if:
(a) the device is a Class I medical device, a Class IIa medical
device or a Class 1 IVD medical device; and
(b) the device can be used safely for its intended purpose
without instructions.
(3) Instructions for the use of a medical device must include
information mentioned below that is applicable to the device.
(1) The manufacturer’s name, or trade name, and address
(2) The intended purpose of the device, the intended user of
the device, and the kind of patient on whom the device is
intended to be used
(3) Information about any risk arising because of other
equipment likely to be present when the device is being
used for its intended purpose (for example, electrical
interference from electro-surgical devices or magnetic
field interference from magnetic resonance images)
(4) Information about the intended performance of the device
and any undesirable side effects caused by use of the
device
(5) Any contraindications, warnings, restrictions on use, or
precautions that may apply in relation to use of the device
(6) Sufficient information to enable a user to identify the
device, or if relevant, the contents of the packaging
(7) Any particular handling or storage requirements applying
to the device
(8) If applicable, an indication that the device is intended for
a single use only
(9) If applicable, an indication that the device has been
custom-made for a particular individual or health
professional and is intended for use only by that
individual or health professional
(10) If applicable, an indication that:
(a) if the device is a medical device other than an IVD
medical device – the device is intended for pre-
market clinical investigation; or
(b) if the device is an IVD medical device – the device is
intended for performance evaluation only
(11) For a sterile device, the word “STERILE” and
information about the method that was used to sterilise
the device
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(12) For a device that is intended by the manufacturer to be
supplied in a sterile state:
(a) an indication that the device is sterile; and
(b) information about what to do if sterile packaging is
damaged and;
(c) if appropriate, instructions for resterilisation of the
device.
(13) For a medical device that is intended by the
manufacturer to be sterilised before use – instructions for
cleaning and sterilising the device which, if followed, will
ensure that the device continues to comply with the
applicable provisions of the essential principles
(14) Any special operating instructions for the use of the
device
(15) Information to enable the use to verify whether the
device is properly installed and whether it can be
operated safely and correctly, including details of
calibration (if any) needed to ensure that the device
operates properly and safely during its intended life
(16) Information about the nature and frequency of regular
and preventative maintenance of the device, including
information about the replacement of consumable
components of the device during its intended life
(17) Information about any treatment or handling needed
before the device can be used
(18) For a device that is intended by the manufacturer to be
installed with, or connected to, another medical device or
other equipment so that the device can operate as
required for its intended purpose – sufficient information
about the device to enable the user to identify the
appropriate other medical device or equipment that will
ensure a safe combination.
(19) For an implantable device – information about any risks
associated with its implantation
(20) For a reusable device:
(a) information about the appropriate processes to allow
reuse of the device (including information about
cleaning, disinfection, packaging, and, if
appropriate, resterilisation of the device); and
(b) an indication of the number of times the device may
be safely reused

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(21) For a medical device that is intended by the
manufacturer to emit radiation for medical purposes –
details of the nature, type, intensity and distribution of the
radiation emitted
(22) Information about precautions that should be taken by a
patient and the user if the performance of the device
changes
(23) Information about precautions that should be taken by a
patient and the user if it is reasonably foreseeable that
use of the device will result in the patient or user being
exposed to adverse environmental conditions
(24) Adequate information about any medicinal product that
the device is designed to administer, including and
limitations on the substances that may be administered
using the device
(25) Information about any medicine (including any stable
derivative of human blood or blood plasma) that is
incorporated, or intended to be incorporated, into the
device as an integral part of the device.
(25A) For a medical device, other than an IVD medical
device, information about any tissues, tissue derivatives,
cells or substances of animal origin that have been
rendered non-viable, or tissues, cells or substances of
microbial or recombinant origin that are included in the
device
(26) Information about precautions that should be taken by a
patient and the user if there are special or unusual risks
associated with the disposal of the device
(27) Information about the degree of accuracy claimed if the
device has a measuring function
(28) Information about any particular facilities required for
use of the device or any particular training or
qualifications required by the user of the device.
(29) For an IVD medical device, information (including, to the
extent practicable, drawings and diagrams) about the
following:
(a) the scientific principle (the ‘test principle’) on which
the performance of the IVD medical device relies;
(b) specimen type, collection, handling and preparation;
(c) reagent description and any limitations (for example,
use with a dedicated instrument only);
(d) assay procedure including calculations and
interpretation of results;

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(e) interfering substances and their effect on the
performance of the assay;
(f) analytical performance characteristics, such as
sensitivity, specificity, accuracy and precision;
(g) clinical performance characteristics, such as
sensitivity and specificity;
(h) reference intervals, if appropriate;
(i) any precautions to be taken in relation to substances
or materials that present a risk of infection
(30) For an adaptable medical device, instructions for
assembling or adapting the device which, if followed, will
ensure that the device continues to comply with the
applicable provisions of the essential principles
(31) For a medical device production system, instructions for
the process to be followed in producing the medical
device the system is intended to produce which, if
followed, will ensure that the device so produced will
comply with the applicable provisions of the essential
principles

13A Patient implant cards and patient information leaflets

Scope of clauses 13A.2 to 13A.4
13A.1 Clauses 13A.2 to 13A.4 apply to a medical device that is: n/a n/a n/a n/a
(a) an implantable medical device or an active implantable
medical device; and
(b) not a suture, staple, dental filling, dental brace, tooth crown,
screw, wedge, plate, wire, pin, clip or connector
Patient implant cards for implantable devices
13A.2 (1) A card (a patient implant card) that meets the requirements
of subclause (2) and clause 13A.4 must be provided with the
medical device.
(2) The card must include the information mentioned in the
following table (in the Regulations).
(1)(a) the name of the device; and
(1)(b) the model of the device; and
(1)(c) the batch code, lot number or serial number of the
device; and
(1)(d) the unique device identifier of the device (if any)
(2) The manufacturer’s name, address and website

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Patient information leaflets for implantable devices

13A.3 (1) A leaflet (a patient information leaflet) that meets the
requirements of subclauses (2) to (4) and clause 13A.4 must
be provided with the medical device.
(2) The leaflet must include the following information:
(a) information identifying the device, or the kind of device;
(b) the intended purpose of the device;
(c) information explaining how to use the device safely;
(d) other information about the device that the manufacturer
considers would be useful for patients.
(3) In particular, the leaflet must include the information
mentioned in the following table (in the Regulations).
(1)(a) the name of the device; and
(1)(b) the model of the device
(2(a) the intended purpose of the device; and
(2)(b) the kind of patient on whom the device is intended to
be used
(3)Any special operating instructions for the use of the device
(4)(a) the intended performance of the device; and
(4)(b) any undesirable side effects that could be caused by
use of the device
(5) Any residual risks that could arise due to any
shortcomings of the protection measures adopted as
mentioned in subclause 2(2)
(6)(a) warnings about risks that could arise from the
interaction of the device with other equipment; and
(6)(b) precautions and other measures that, because of
those risks, should be taken by the patient or a health
professional
Example 1: The risk of electrical interference from electro-
surgical devices.
Example 2: The risk of magnetic field interference from
magnetic resonance imaging devices.
(7)(a) the nature and frequency of regular or preventative
examination, monitoring or maintenance of the device
that should be undertaken; and
(7)(b) symptoms that could indicate that the device is
malfunctioning; and
(7)(c) precautions and other measures that should be taken
by the patient if the performance of the device changes or
the patient experiences any of the symptoms mentioned
in paragraph (b); and
(7)(d) the expected device lifetime; and

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(7)(e) anything that could shorten or lengthen the device
lifetime; and
(7)(f) precautions and other measures that should be taken
at, or near, the end of the expected device lifetime; and
(7)(g) other circumstances in which the patient should
contact a health professional in relation to the operation
of the device
(8)(a) the materials and substances included in the device;
and
(8)(b) any manufacturing residuals that could pose a risk to
the patient
(9) (a) a notice that any serious incident that occurs in
relation to the device should be reported to the
manufacturer and to the Therapeutic Goods
Administration; and
(9)(b) the address of the Therapeutic Goods Administration’s
website
(4) The information in the leaflet must be written in a way that is
readily understood by patients.
Form of patient implant cards and patient information
13A.4 leaflets
(1) The information required by clause 13A.2 or 13A.3 to be
included in a patient implant card or patient information
leaflet:
(a) must be included in English; and
(b) may also be included in any other language.
Note: The information may also include diagrams or drawings.
(2) Any number, letter, symbol, or letter or number in a symbol,
used in a patient implant card or patient information leaflet
must be:
(a) legible; and
(b) at least 1 millimetre high.

13B. Software – version numbers and build numbers

(1) For a medical device that is software, or that incorporates
software, the current version number and current build
number of the software must be accessible by, and
identifiable to, users of the device.
(2) The current version number and current build number of the
software:
(a) must be in English; and
(b) may also be in any other language.

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14. Clinical evidence

Every medical device requires clinical evidence, appropriate for
the use and classification of the device, demonstrating that the
device complies with the applicable provisions of the essential
principles.
Note: See regulation 3.11 and the clinical evaluation
procedures.

15. Principles applying to IVD medical devices only

An IVD medical device must be designed and manufactured in a
15.1 way in which the analytical and clinical characteristics support
the intended use, based on appropriate scientific and technical
methods.
An IVD medical device must be designed in a way that
15.2 addresses accuracy, precision, sensitivity, specificity, stability,
control of known relevant interference and measurement of
uncertainty, as appropriate.
If performance of an IVD medical device depends in whole or
15.3 part on the use of calibrators or control materials, the traceability
of values assigned to the calibrators or control material must be
assured through a quality management system.
An IVD medical device must, to the extent reasonably
15.4 practicable, include provision for the user to verify, at the time of
use, that the device will perform as intended by the
manufacturer.
An IVD medical device for self-testing must be designed and
15.5 manufactured so that it performs appropriately for its intended
purpose, taking into account the skills and the means available
to users and the influence resulting from variation that can
reasonably be anticipated in the user’s technique and
environment.
The information and instructions provided by the manufacturer of
15.6 an IVD medical device for self-testing must be easy for the user
to understand and apply.
An IVD medical device for self-testing must be designed and
15.7 manufactured in a way that reduces, to the extent practicable,
the risk of error in the use of the device, the handling of the
sample and the interpretation of results.
These clause numbers are in Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)

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