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This form, when completed, will be classified as 'For official use only'.
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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: [email protected] https://www.tga.gov.au
Reference/Publication #
 Schedule Essential Principle from the Regulations Applicable/ Medical Device Other standards or Evidence of compliance
1: Not Standards applied by procedures applied by or reason for non-
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
2. conform with 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

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(d) fourth, inform users of any residual risks that may arise
2 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.
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
5. transport or 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.

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Benefits of medical devices to outweigh any

6. undesirable 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
7.2 and 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.

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7. Chemical, physical and biological properties

(2) In minimising risks, particular consideration must be

7.2 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:
(a) the safety and quality of the substance must be
verified in 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
7.5 substances
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.

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Minimisation of risks associated with ingress or egress

7.6 of 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.

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.
Control of animal, microbial or recombinant tissues,
8.2 tissue 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.

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(2) If the tissues, tissue derivatives, cells or substances

8.2 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
8.5 and 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

9.1 with 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.

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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;
(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.

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(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.
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.

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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.
(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.

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(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

12.1 software 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

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

12.1 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
(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.

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(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
(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.

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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
12.4 parameters
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.

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Protection against risks associated with administration

12.12 of 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.
(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.

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13. Information supplied by the manufacturer

Information to be provided with medical devices –

13.1 general
(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
(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

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Information to be provided with medical devices –

13.2 location
(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.

Information to be provided with medical devices –

13.3 particular 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

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(3) Sufficient information to enable a user to identify the

13.3 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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Part 2. Principles about design and construction

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

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(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
(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

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(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.
(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

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(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;

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(c) reagent description and any limitations (for

example, use with a dedicated instrument
only);
(d) assay procedure including calculations and
interpretation of results;
(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

13A.1 Scope of clauses 13A.2 to 13A.4 n/a n/a n/a n/a

Clauses 13A.2 to 13A.4 apply to a medical device that is:
(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

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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
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)

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(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
(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

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(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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Part 2. Principles about design and construction

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

15.1 manufactured in a 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
15.3 or 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
15.5 and 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
15.6 manufacturer of an IVD medical device for self-testing must
be easy for the user to understand and apply.

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An IVD medical device for self-testing must be designed

15.7 and 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

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