AUSTRALIAN MEDICAL DEVICES
GUIDELINES
An Overview of the New Medical Devices
Regulatory System
Guidance Document Number 1
Version 1.6
DISCLAIMER
This document is provided for guidance only. It should not be relied upon to address every aspect
of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the
Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical
Devices) Regulations 2002 for legislative requirements.
FURTHER INFORMATION
The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the
Therapeutic Goods Administration (TGA) can be contacted by:
Telephone: 1800 141 144
Facsimile: (02) 6232 8299
Email: cab.medical.device.information@health.gov.au
Website: www.tga.gov.au/devices/devices.htm
Mail: PO Box 100
Woden
ACT 2606
Ó Commonwealth of Australia 2003
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AMENDMENT SCHEDULE
Version Date of
Summary of Amendments
Number Amendment
1.6 23 May 2003 Inclusion of section on offences, penalties and cancellations.
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CONTENTS
Disclaimer ..............................................................................................................................................2
Further information................................................................................................................................2
Amendment schedule ............................................................................................................................3
Introduction............................................................................................................................................5
What is a medical device? .....................................................................................................................5
How are medical devices regulated? ....................................................................................................5
Structure of the revised Therapeutic Goods Act 1989 .........................................................................7
Are all medical devices covered by the new legislation? ....................................................................7
The Australian Register of Therapeutic Goods....................................................................................8
Transition period....................................................................................................................................8
Fees and charges ....................................................................................................................................9
How are medical devices classified? ....................................................................................................9
How does classification relate to conformity assessment?................................................................10
Who is responsible for the conformity assessment of a medical device? .........................................11
What are the essential principles? .......................................................................................................11
How do standards relate to the essential principles?..........................................................................11
Once a medical device has been approved for supply, what systems are in place for detecting and
reporting problems?.............................................................................................................................12
What schemes are in place to access unapproved medical devices?.................................................12
Offences, penalties and cancellations .................................................................................................13
Offences and penalties .....................................................................................................................13
Other penalties..................................................................................................................................13
Cancellations ....................................................................................................................................14
Enforcement.........................................................................................................................................14
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INTRODUCTION
This guidance document is one of a series that has been produced to help explain the new
regulatory system for medical devices in Australia that commenced on 4 October 2002. The new
system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic
Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices)
Regulations 2002.
Many other guidance documents are available in this series. The series was developed to assist a
wide-ranging audience and additional documents can be included if there is enough demand. A
separate guidance document is available describing the series.
Although each guidance document has been developed to provide information about particular
aspects of the new medical devices regulatory system in Australia, it is expected that a certain
amount of cross-referencing to other documents in the series will be inevitable.
WHAT IS A MEDICAL DEVICE?
A medical device is defined in the legislation as “any instrument, apparatus, appliance, material or
other article (whether used alone or in combination, and including the software necessary for its
proper application) intended by the person under whose name it is to be supplied, to be used for
human beings for the purposes of one or more of the following:
£ diagnosis, prevention, monitoring, treatment or alleviation of disease,
£ diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap,
£ investigation, replacement or modification of the anatomy or of a physiological process,
£ control of conception,
and does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means; or
an accessory to such an instrument, apparatus, appliance, material or other article.”
It should be noted that a key part of this definition is the intended purpose specified by the
manufacturer of the medical device.
An accessory, to a medical device, is an article, or articles intended specifically by its
manufacturer to be used together with the medical device to enable the medical device to be used
as intended by its manufacturer.
HOW ARE MEDICAL DEVICES REGULATED?
The Therapeutic Goods Act 1989 provides the legislative basis for uniform national controls over
goods used in the prevention, diagnosis, curing, or alleviation of a disease, ailment, defect or
injury.
It is important to know the current regulatory requirements. Copies of the legislation can be
obtained from Government Info Shops in each capital city or from Internet web sites such as the
Attorney General’s Department’s law resource at http://scaleplus.law.gov.au.
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The Therapeutic Goods Administration (TGA), a Division of the Commonwealth Department of
Health and Ageing, is responsible for administering the Therapeutic Goods Act 1989. The Office
of Devices, Blood and Tissues (ODBT) is the area within the TGA responsible for regulating
medical devices.
Three statutory committees have been established to provide advice on the regulation of
therapeutic goods. They are the:
£ Medical Devices Evaluation Committee (MDEC) which provides advice to the
Minister on issues relating to the safety, quality, performance and timely availability of
medical devices. The Committee also provides advice on the policies, procedures and
priorities that should be applied to the administration of the medical devices legislation.
£ Therapeutic Goods Committee (TGC) which advises the Minister on standards
relating to therapeutic goods, as well as the raw materials, manufacturing processes and
testing procedures used to make them.
£ National Coordinating Committee on Therapeutic Goods (NCCTG), consisting of
representatives from the States, Territories and the Commonwealth, which discusses
many aspects of the regulation of therapeutic goods (including medical devices).
The new medical devices legislation incorporates accepted best practice relating to safety, quality
and risk management procedures, as well as providing the flexibility and capacity to regulate new
and changing technology. The new framework also adopts the philosophies of the Global
Harmonisation Task Force on medical devices.
The new regulatory system has the following features:
£ a device classification scheme based on different levels of risk for each class of device;
£ essential principles for the quality, safety and performance of the medical device that
must be complied with before the product can be supplied;
£ options as to how compliance with the essential principles can be satisfied and assessed
– manufacturer quality systems, type testing, and design evaluation;
£ the use of recognised standards to satisfy the requirements of the essential principles;
£ a comprehensive post market surveillance and adverse incident reporting program;
£ appropriate regulatory controls for the manufacturing processes of medical devices; and
£ the continued use of the Australian Register of Therapeutic Goods as the central point of
control for the legal supply of medical devices in Australia.
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STRUCTURE OF THE REVISED THERAPEUTIC GOODS ACT 1989
The Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical
Devices) Bill 2002 has been divided into chapters as outlined below:
£ Chapter 1 – Preliminary
£ Chapter 2 – Australian Register of Therapeutic Goods
£ Chapter 3 – Medicines and other Therapeutic Goods that are not Medical Devices
¤ Part 3-1 Standards
¤ Part 3-2 Registration and Listing of Therapeutic Goods
¤ Part 3-3 Manufacturing
£ Chapter 4 – Medical Devices
¤ Part 4-1 Introduction
¤ Part 4-2 Essential Principles and Medical Device Standards
¤ Part 4-3 Conformity Assessment Principles
¤ Part 4-4 Conformity Assessment Certificates
¤ Part 4-5 Including Medical Devices in the Register
¤ Part 4-6 Suspension and Cancellation from the Register
¤ Part 4-7 Exempting Medical Devices from Inclusion in the Register
¤ Part 4-8 Obtaining Information
¤ Part 4-9 Public Notification and Recovery of Medical Devices
¤ Part 4-10 Assessment Fees
¤ Part 4-11 Enforcement
£ Chapter 5 – Advertising, Counterfeit Therapeutic Goods and Product Tampering
¤ Part 5-1 Advertising
¤ Part 5-2 Counterfeit Therapeutic Goods
¤ Part 5-3 Product Tampering
£ Chapter 6 – Administration
¤ Part 6-1 Payment of Charges
¤ Part 6-2 Entry, Searches and Warrants
¤ Part 6-3 National Drugs and Poisons Schedule Committee
£ Chapter 7 – Miscellaneous
£ Chapter 8 – Repeal and Transitional Provisions
ARE ALL MEDICAL DEVICES COVERED BY THE NEW LEGISLATION?
Some products, which were previously regulated as therapeutic devices, are not covered by the
new legislation. These products will be known as ‘Other Therapeutic Goods’. They either do not
fit the new definition of a medical device or else it has been decided that they should remain under
the previous regulatory system while more specific requirements for their regulation are
developed. More information can be found in the guidance document dealing with Other
Therapeutic Goods.
Examples of products not meeting the new definition of a medical device are:
£ tampons; and
£ hospital, household and commercial grade disinfectants.
Products remaining under the current regulatory system are:
£ in-vitro diagnostic devices; and
£ devices of human origin.
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THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
The Australian Register of Therapeutic Goods (ARTG) continues to be the central point of control
for the legal supply of therapeutic goods in Australia. The ARTG is the register of information
about therapeutic goods for human use that may be imported, supplied in, or exported from
Australia. Under the legislation some therapeutic goods have been specifically excluded from
entry in the ARTG while others may be given specific approval for a special purpose without
being entered in the Register.
Following the amendments to the Therapeutic Goods Act 1989, an additional part has been created
in the ARTG for medical devices. The new part is for medical devices included in the Register.
The parts of the ARTG for goods known as registered and listed goods will remain.
Therapeutic goods, which are currently registered or listed in the Register, cannot be transferred to
the new part.
An application will be required to have a medical device included in the ARTG. Sponsors are
encouraged to use the Devices Electronic Application Lodgement system (DEAL) for these
applications. DEAL will also be used to lodge details of medical device manufacturers, and the
required declarations of conformity, before applications can be submitted to have a medical device
included in the ARTG for all classes of medical devices, except for Class I.
TRANSITION PERIOD
The Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical
Devices) Act 2002, has made provision for the following transition periods for certain therapeutic
goods:
£ Medical devices that are currently registered or listed goods in the ARTG can remain
registered or listed until 4 October 2007. However, any registered or listed therapeutic
devices in the ARTG after that date will be automatically cancelled. During this 5-year
transition period an application can be made to include those goods in the ARTG. If the
application is successful the registrations or listings will then be cancelled; or
£ Medical devices that are exempt goods will remain exempt until 4 October 2004. After
that time those goods, if they no longer satisfy the definition of exempt goods, will have
to become included medical devices in the ARTG so that they can be supplied in
Australia; or
£ Applications for entry in the ARTG for listable therapeutic devices manufactured in
Australia that do not currently require a manufacturing licence from the TGA will still
be accepted until 4 October 2004.
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FEES AND CHARGES
From 1 July 1998, the TGA has been required by the Commonwealth Government to fully recover
its operating costs for all activities that fall within the scope of the Therapeutic Goods Act 1989,
including the regulation of industry and the TGA’s public health responsibilities.
The fees and charges for the revised regulatory program, detailed in schedule 5 of the Therapeutic
Goods (Medical Devices) Regulations 2002, is summarised in a document available from the TGA
web site at http://www.tga.gov.au/devices/devices.htm.
HOW ARE MEDICAL DEVICES CLASSIFIED?
The new regulatory regime adopts a classification system to categorise medical devices. The
system uses a set of classification rules (see the Guidance Document on the Classification of
Medical Devices) based on:
£ the manufacturer’s intended use
£ the level of risk; and
£ the degree of invasiveness in the human body.
There are five classes of medical devices:
£ Class I
£ Class IIa
£ Class IIb
£ Class III
£ Active Implantable Medical Devices (AIMD)
The examples shown in the following table are for guidance only. The classification may change
depending on the site of use, the addition of a medicinal component, or the intended purpose
specified by the manufacturer.
Class I Class IIa Class IIb Class III AIMD
Beds Anaesthetic Anaesthetic Absorbable sutures Implantable drug
breathing circuits machines infusion devices
Cervical collars Bridges apnea monitors Breast implants Implantable pulse
generators
Compression hosiery Blood bags Condoms with
spermicides
Cotton wool Crowns Baby incubators Cortical electrodes
Dental curing lights Cryosurgery Blood pumps for Heart valves
equipment heart-lung machines
Dental impression Dental drills Blood warmers Heparin coated
materials catheters
Examination gloves Dental filling Brachytherapy Implantable
materials devices electrodes
External electrodes Devices for storage Cell separators Intrauterine devices
or transport of organs
for transplantation
Gauze dressings Devices for long- Condoms Neurological
term storage of catheters
corneas, sperm,
embryos etc
Gels External bone Contact lens care Temporary pacing
growth stimulators products leads
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Class I Class IIa Class IIb Class III AIMD
Manual drills and Fixed dental Contraceptive Vascular prostheses
saws prostheses diaphragms
Ostomy pouches Gamma cameras Diagnostic X-ray Vascular stents
sources
Prostatic balloon Hearing aids External
dilatation catheters defibrillators
Removable dentures Hydrogel dressings External pacemakers
Reusable scalpel Infusion cannulae Haemodialysers
handles
Reusable drill bits Magnetic resonance Infusion ports
equipment
Reusable retractors Single-use catheters Instrument grade
disinfectants
Reusable forceps Suction catheters Insulin pens
Scalpels TENS devices Intensive care
monitoring systems
Software for image Tracheal tubes Linear accelerators
processing
Spectacles Vaginal pessaries Lithotriptors
Stethoscopes X-ray films Lung ventilators
Thermographic Non-absorbable
imagers sutures
Tubing for gravity Orthopaedic implants
drips
Walking aids Penile implants
Wheelchairs Peripheral vascular
grafts
Radioactive therapy
sources
Stents
Sterilants
Surgical adhesives
Surgical diathermy
Surgical lasers
Ventilators
HOW DOES CLASSIFICATION RELATE TO CONFORMITY
ASSESSMENT?
The classification of a medical device determines the conformity assessment procedure(s) a
manufacturer can choose to ensure that the device is adequately assessed to conform to the
particular requirements for the class of device.
Higher class devices undergo a more stringent form of conformity assessment than lower class
devices. Certification by the TGA or an overseas notified body is required for higher risk devices.
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WHO IS RESPONSIBLE FOR THE CONFORMITY ASSESSMENT OF A
MEDICAL DEVICE?
The responsibility for conformity assessment rests with the manufacturer of a medical device. The
role of the TGA, or an overseas notified body, is to issue certification after they have confirmed
that the conformity assessment procedures are appropriate and have been applied. This
intervention will vary according to the class of the device.
Assessment by the TGA is also required for Australian manufacturers of medical devices intended
for supply in Australia.
WHAT ARE THE ESSENTIAL PRINCIPLES?
The essential principles of safety and performance apply to all medical devices. The risks of using
a medical device must be outweighed by the benefits gained from the use of the medical device.
The essential principles, detailed in Schedule 1 of the Therapeutic Goods (Medical Devices)
Regulations 2002, list the requirements for all medical devices. There are two main categories.
The general principles apply to all devices. The applicability of the principles dealing with design
and construction will depend on the intended purpose and properties of the medical device. The
essential principles include:
£ General Principles
¤ the use of a medical device must not compromise health and safety
¤ the design and construction of a medical device has to conform with safety principles
¤ medical devices are to be suitable for the intended purpose
¤ long term safety
¤ medical devices are not adversely affected by transport or storage
¤ the benefits of medical devices are to outweigh any side effects
£ Principles about Design and Construction
¤ chemical, physical and biological properties
¤ infection and microbial contamination
¤ construction and environmental properties
¤ medical devices with a measuring function
¤ protection against radiation
¤ medical devices connected to or equipped with an energy source
¤ information to be provided with medical devices
¤ clinical evidence
HOW DO STANDARDS RELATE TO THE ESSENTIAL PRINCIPLES?
The essential principles set out the requirements relating to the safety and performance
characteristics of medical devices. Compliance with applicable medical device standards is not
required, but it is one way to establish compliance with the essential principles. If a manufacturer
uses a medical device standard, or a number of medical device standards, this will allow a
presumption of conformance with the relevant essential principles. Medical device standards will
be identified by orders in the Commonwealth Gazette. Other standards can also be used to show
conformance with the relevant essential principles, however these will not allow a presumption of
compliance.
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ONCE A MEDICAL DEVICE HAS BEEN APPROVED FOR SUPPLY, WHAT
SYSTEMS ARE IN PLACE FOR DETECTING AND REPORTING
PROBLEMS?
The new legislation includes a mandatory reporting system for adverse events involving all
medical devices. The system is known as the Vigilance System and is based on the
recommendations of the Global Harmonisation Task Force (GHTF) Study Group 2: Vigilance and
Surveillance.
Sponsors are required to report any problem to the manufacturer of the device. Manufacturers are
required to report the problem to the TGA. For further information on what types of problems are
required to be reported, please refer to the post market guidance document.
The Vigilance System comprises:
£ penalties and time frames
£ recall and seizure provisions
£ voluntary reporting provisions for medical device users
£ international information exchange between conformity assessment bodies
£ information exchange between inter governmental agencies within Australia (such as
Health Care Complaints Commission and coronial inquests)
Post market surveillance of medical devices by the TGA includes the compliance testing of
medical devices and a TGA audit of the technical files and certification for products not assessed
as part of an application to supply the medical device in Australia.
WHAT SCHEMES ARE IN PLACE TO ACCESS UNAPPROVED MEDICAL
DEVICES?
The revised Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment
(Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002
provide access to medical devices not entered on the ARTG under the following special access
and supply arrangements:
£ Clinical trials (either the clinical trial exemption (CTX) scheme or the clinical trial
notification (CTN) scheme, where both schemes require human research ethics
committee approval;
£ The Special Access Scheme (Categories A and B);
£ Authorised Prescribers; and
£ Importation for personal use.
The Special Access Scheme (SAS) refers to the arrangements that allow access to unapproved
products by individual patients, other than by personal importation. The arrangements are
dependent on whether the patients are classified as Category A, as defined in the Regulations. The
use of a medical device for a Category A patient only requires notification while Category B
patients require approval by a TGA delegate.
A detailed document, “Access to Unapproved Therapeutic Goods in Australia” is available from
the TGA website, “www.tga.gov.au/devices/devices.htm”.
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OFFENCES, PENALTIES AND CANCELLATIONS
Offences and penalties
The offences in the Act include:
£ illegal importation, exportation, manufacture or supply of medical devices not included
in the register and not subject to an appropriate exemption (section 41MI with maximum
penalties for individuals of imprisonment for 12 months or $110 000, or both, and $550 000
for corporations);
£ non-compliance with the essential principles, unless the Secretary has consented
(sections 41MA with maximum penalties for individuals of imprisonment for 12 months or
$110 000, or both, and $550 000 for corporations);
£ non-application of an appropriate conformity assessment procedure (sections 41ME and
41MF with maximum penalties for individuals of imprisonment for 12 months or $110 000,
or both, and $550 000 for corporations);
£ failure to comply with the conditions of entry in the ARTG (section 41MN with
maximum penalties of $26 400 for individuals and $132 000 for corporations);
£ failure to comply with the conditions of a conformity assessment certificate (section
41MN with maximum penalties of $26 400 for individuals and $132 000 for corporations);
£ failure to notify adverse events (section 41MP with maximum penalties of $44 000 for
individuals and $220 000 for corporations);
£ failure to notify adverse events etc where an application is withdrawn or lapses (section
41MQ with maximum penalties of $44 000 for individuals and $220 000 for corporations);
£ misuse of medical devices exempted for special or experimental uses (section 41MO
with maximum penalties of $6 600 for individuals and $33 000 for corporations);
£ claims about arranging supplies of medical devices not included in the ARTG (section
41MM with maximum penalties of $6 600 for individuals and $33 000 for corporations);
£ making false declarations at the time of entry in the ARTG (section 41MH with
maximum penalties for individuals of imprisonment for 12 months or $220 000, or both,
and $1 100 000 for corporations) and;
£ making misrepresentations about medical devices (section 41ML with maximum
penalties of $6 600 for individuals and $33 000 for corporations).
Other penalties
In addition to financial penalties for offences under the Act, other penalties can be applied for a
failure to comply with provisions of the Act. These include:
£ suspension or cancellation of the medical device from the ARTG (Part 4-6);
£ suspension or revocation of conformity assessment certification (Part 4-4 Division 3 and
Division 4); and the
£ recall of medical devices supplied, either to batch level or all medical devices (section
41MI(1)).
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Cancellations
The TGA will cancel products from the register under Part 4-6 of the Act only in those cases
where there has been a severe breach of the law or, more often, where there is a safety concern
associated with the use of the product. If a sponsor cannot satisfactorily establish the quality, safety
or efficacy of their product and a decision to cancel the entries in the ARTG is confirmed, the
sponsor will also be required to recall any affected products.
The principles of natural justice are followed by the TGA whenever a proposal to cancel a product
in the ARTG is considered. The cancellation proposal will be submitted to a sponsor and they will
be allowed a certain period of time to show cause why the cancellation should not take occur. The
sponsor may also be given the opportunity to submit any data to support their case. A decision will
be made when this time has elapsed and any submitted information has been assessed. If it is
decided to cancel the registration, listing or inclusion, sponsors normally have an opportunity to
lodge an appeal. The sponsor’s rights in the cancellation process are explained in the cancellation
letter.
ENFORCEMENT
The Surveillance Unit of the TGA:
£ monitors compliance with the Act,
£ investigates alleged breaches of the Act, and
£ initiates criminal prosecutions where appropriate.
Information regarding the illegal supply of medical devices should be referred to this Unit.
Options available to the TGA include criminal prosecutions under section 5A for offences
included in the Act and fines detailed in many other parts. Illicit goods that have been seized
during these investigations are forfeited to the Commonwealth and destroyed.
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