introduces a new regulatory system.
Disclaimer: The information contained on this website is derived from
public sources and is current to the best of our knowledge. For detailed
and definitive information about a country's laws and policies, the
government of the country concerned should be consulted.
The Australian medical devices industry plays an important role in Australia's
health sector and in 2001 was a US$1.1 billion industry. Australia is
among the world leaders in ensuring high standard international regulation
and is one of the five members of the Global Harmonization Task Force
(GHTF) for medical devices along with the U.S., Canada, the European
Union and Japan.
A formal arrangement for regulating medical devices commenced in Australia
in 1987 in response to concerns about the many medical devices coming
onto the market as a result of technological advances and the increasing
role of devices in health care. Before any medical device can be supplied
in Australia, details must be included in the Australian Register of
Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic
Goods Administration (TGA). There are approximately 24,000 product entries
in the ARTG for medical devices. The Therapeutic Goods Act of 1989 regulates
the supply of therapeutic goods in Australia, with the intention of
protecting health care workers and the Australian public by ensuring
the safety, quality and efficacy of therapeutic goods used in Australia,
whether the goods are produced in Australia or elsewhere.
Companies should be aware that a new harmonized system governing the
supply of medical devices in Australia will come into effect from October
5, 2002. After that time, all new medical devices will be required to
comply with the new harmonized requirements, except a small group of
products (which will have until October 4, 2004, to meet the new requirements).
This new regulatory system is based on the guidelines of the Global
Harmonization Task Force (GHTF) and the European Community (EC) requirements,
and will directly affect Australian importers, exporters and manufacturers
of medical devices. More details on these changes are included below.
current regulatory system (http://www.health.gov.au/tga/docs/html/dr4.htm),
all medical devices made available for sale in Australia must be included
in the Australian Register of Therapeutic Goods (ARTG) as either "registrable"
or "listable" devices (see below), unless specifically exempted.
Medical devices fall into three categories for purposes of inclusion
in the ARTG: registrable, listable and exempt. Medical devices considered
critical, such as cardiac pacemakers, powered drug infusion systems,
and HIV and hepatitis C in vitro diagnostic kits, are REGISTRABLE devices.
These products are evaluated comprehensively for their quality, safety
and efficacy before they are permitted to be supplied on Australia's
market. Most other devices are LISTABLE, and are given a briefer assessment
to check conformity to manufacturing, labeling and quality standards.
In the case of U.S. companies wishing to supply the Australian market,
an Australian sponsor must make application to the TGA on their behalf.
This sponsor is usually the distributor. Once a product is listed on
the ARTG, sponsorship can be transferred, if required. For example,
if a U.S. company wishes to change from Distributor A, who had been
the sponsoring company for registration on the ARTG, to Distributor
B, then a transfer of sponsorship form would need to be completed. This
may not be done without the knowledge of Distributor A. The change of
sponsor process does not affect the listing or registration of the product
on the ARTG.
The TGA has a monopoly on assessing compliance with the legislation,
and is required to cover some costs through fees and charges to industry.
Schedules of application fees can be obtained from the TGA's website.
Good Manufacturing Practices
The Therapeutic Goods Act requires that the standard of manufacture
of imported products be taken into consideration for registration and
listing. Under the Act, the term "manufacture" includes all
or any of the steps of compounding, processing, assembling, packaging,
labeling, sterilization, testing and release for sale. The sponsor can
either supply an "acceptable form of evidence" or agree to
pay the costs of an Australian auditor, if Good Manufacturing Practice
(GMP) audit is considered necessary. For therapeutic goods (or components
thereof) imported into Australia, the TGA recognizes suitable certification
resulting from other countries GMP audits as equivalent TGA certification.
For U.S. manufacturers, evidence of an acceptable U.S. FDA audit may
be submitted (note: the inspection must have been a "full"
FDA establishment inspection, and must have been completed within the
past three years); or a current Device Manufacturers License issued
by the Food and Drug Branch of the California Department of Health.
The TGA's website (see below) contains extensive information on GMP
requirements and prospective suppliers to the Australian market are
advised to review this material.
As many applications for listing or registration on the ARTG are either
delayed or rejected due to inadequate evidence of GMP compliance, the
TGA has enabled sponsors to request a clearance assessment of the GMP
evidence for an overseas manufacturer prior to actually submitting an
application. This involves submission of a clearance form for each manufacturing
site. A fee may be payable for this service, if the GMP Audit and Licensing
Section is required to liaise with other overseas bodies to confirm
the status of the manufacturer. This completed form, with the GMP Audit
and Licensing Section ruling on its acceptability, may then be submitted
as part of an application by the sponsor as evidence of GMP compliance.
Listing or Registration Applications
The application for listable or registrable therapeutic devices (valid
for original submissions or modifications) can be obtained from TGA's
website at link http://www.health.gov.au/tga/docs/pdf/devform.pdf.
In addition, an Enterprise Details Form should be completed by or for
each enterprise in cases where the application is the enterprise's first
in Australia, or its address or authorized representatives have changed
since the previous application (the Enterprise Details Form may accompany
applications for registration, listing or clinical trial, or may be
sent separately). Applications are assigned to the TGA's Business Management
Unit, and are assigned a Therapeutic Goods Application Identification
Number (TGAIN), which should be cited in any inquiries concerning a
Where required (as in the case of certain registrable devices), clinical
investigations must conform to standards set forth in the World Medical
Association's Helsinki Declaration on clinical research involving human
subjects. Resulting data must be presented in accordance with ISO 14155.
Labels must be in English and must include the name of the therapeutic
device; the name and address of the manufacturer or sponsor; the batch
and serial number; and (for devices packaged with other devices or substances)
the name and quantity of the other goods or substances included in the
same package with the subject device. (Labeling requirements are modified
accordingly for sterile devices and implantable devices).
Coming Soon - Proposed New Harmonized Regulatory System
The new harmonized system governing the supply of medical devices in
Australia will come into effect from October 5, 2002. After that time,
all new medical devices will be required to comply with the new harmonized
requirements, except a small group of products. Products that are currently
exempt will have until October 4, 2004, to meet the new requirements.
To reduce confusion, during the transition period devices introduced
to the market under the current system will be denoted as "therapeutic
devices," while those introduced under the new system will be referred
to as "medical devices."
The purpose of the change is to harmonize the Australian system with
international regulatory practices. Legislation to amend the Therapeutic
Goods Act was introduced in the Australian Parliament in March 2001.
The bill incorporates principles of safety, performance, and vigilance,
as recommended by the Global Harmonization Task Force for medical devices
(of which Australia is a member, along with the United States, Canada,
the European Union and Japan). Australia's 1998 Mutual Recognition Agreement
with the European Union has led the way toward a more "harmonized"
regulatory system, and the new Australian regulatory model incorporates
elements of EU regulatory requirements, although not the EU's private
sector ("Third Party") evaluation system. While major elements
of the current legislation will be retained, the changes will introduce
different medical device classifications and pre-market assessment requirements.
The proposed new system includes:
Expression of the essential requirements for medical devices;
requirements for "exempt" Class I devices;
comprehensive pre-market assessment of new technologies, high-risk active
devices and implantable devices;
reliance on international standards; and
mechanisms for requiring sponsors to monitor report device problems,
with greater emphasis on post-market activities, such as vigilance.
inspections of manufacturers' quality systems and labeling and advertising
requirements are not expected to change significantly from the current
system. The new system will facilitate the electronic entry of applications
for inclusion of devices in the ARTG, using the new Device Electronic
Application Lodgement system (DEAL). The main changes relate to medical
device classification, pre-market assessment requirements and post-market
device problem reporting.
a) Device Classification
Under the soon to be implemented regulatory regime (see below for more
details), most medical devices will be classified into one of five classes:
Classes I, IIa, IIb, III and Active Implantable Medical Devices (AIMDs).
As of this writing, the placement of in-vitro diagnostic medical devices
in the new system is still under consideration.
Many devices classified "exempt" from inclusion in the ARTG
under the current regime will become Class I (for example, non-powered
hospital furniture and simple non-sterile, non-powered surgical and
dental instruments). In addition, some devices, classified "listable"
under the current regime (such as thermometers, gauze dressings and
stethoscopes), will also become Class I devices. Other "listable"
medical devices (such as hearing aids, dental filling materials and
oxygen meters) will become Class IIa devices. Higher-risk devices, including
some classified "listable" and most of those classified "registrable"
under the current system, will become Class IIb and III devices.
All classes will be required to demonstrate conformity with safety and
performance requirements. Class IIa, IIb, III and AIMD devices will
require quality systems verification. Class III devices and AIMDs will
be subject to the most extensive pre-market assessments.
A brief description of the five new classes follows:
Class I - Low risk: These devices are non-invasive & simple or invasive
& transient use/reusable, etc., e.g., stethoscopes, examination
gloves, dentures, wound dressings and simple surgical implements.
Class II - Intermediate risk: Devices in this class are subdivided into
Class IIa and Class IIb, depending on the level of invasiveness.
Class IIa devices are non-invasive for channeling or body fluid modifiers;
special dressing; invasive & short term use; diagnostic active;
device hospital and household/ commercial grade disinfectants, e.g.,
infusion tubing, polymer film dressing, urinary catheters, suture needles.
Class IIb devices include 'healing' wound dressings; surgically invasive;
implantable; active; contraceptives; blood bags, etc., e.g., hemodialysers,
insulin pens, bone cement, intra-ocular lenses, anaesthetic machines.
Class III - High risk: These devices include the surgically invasive,
including medicine and animal-derived products, e.g., all active implantable
devices, cardiovascular catheters, absorbable sutures, heart valves
and collagen implants.
AIMD - Active implantable medical devices, equivalent to in risk to
Further information on the classification rules can be obtained from
the TGA website: http://www.health.gov.au/tga/docs/html/devregdr.htm.
These Australian rules are similar to the EC rules.
Provision will be made for applications for entry on the ARTG to be
lodged electronically using the Device Electronic Application Lodgement
system (DEAL). All medical devices currently approved for use in Australia
will have five years (until October 4, 2007) to comply with the new
b) Premarket Assessment
The ARTG will remain the central point of control for the legal supply
of medical devices. Medical device in all classes will comply with a
minimum requirement for safety and performance, and will be included
in the ARTG. The level of assessment is commensurate with the level
and nature of the risks posed to consumers. Class IIa, IIb, III and
AIMD devices will require quality systems. Class III devices and AIMD
will be subject to the most extensive premarket assessment in the new
system. Class I devices will be subject to manufacturer self-assessment,
while Class III devices will require TGA assessment. (Note: Under the
current system, less than 5% of devices are registrable and thus subject
to detailed pre-market evaluation for quality, safety and efficacy.)
c) Postmarket Requirements
The postmarket requirements regarding medical devices have been expanded
under the new system. These requirements address the following:
Evidence of conformity;
(with manufacturers assessed for conformance via a manufacturing quality
system, subject to verification via periodic inspections);
and standards (failure to comply with essential requirements renders
a product liable to be withdrawn by the regulatory authority);
system (mandatory reporting system for all events associated with the
performance of a device leading to death or serious deterioration in
the health of a patient or user).
Sponsors must advise the TGA of serious device incidents within 10 days
and non-serious incidents within 30 days. As is the case now, the responsibility
for the safety and performance of medical devices will remain with the
sponsors and manufacturers.
In addition, there will be new requirements regarding device tracking,
which is not currently covered in the Therapeutic Goods Act 1989. There
will be provision made in the legislation to track specific high-risk
devices to the hospital level. Devices to be tracked are yet to be determined,
but could include such items as active implantable cardiac devices,
prosthetic heart valves, silicone gel-filled prostheses and implantable
devices of biological origin.
Further information can be obtained from the TGA website: http://www.health.gov.au/tga/devices/devices.htm
Therapeutic Goods Administration: For detailed information on medical
regulations and the Therapeutic Goods Administration, including downloadable
forms and information on the new regulatory regime, U. S. firms may
wish to visit the medical device page of the Therapeutic Goods Administration
website at http://www.health.gov.au/tga/devices/devices.htm; or contact:
The Information Officer
Conformity Assessment Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
61-2-6232-8686 (inquiries regarding status of medical device listing
61-2-6232-8777 (inquiries regarding status of medical device registration
Standards: Australian standard specifications and codes provide the
basis for uniformity in design, safety, performance, purchase and application
of equipment in health care facilities and institutions. In line with
Standards Australia policy, these standards are based to the maximum
extent possible on relevant international standards and take account
of safe practices well established in Australia. Details on Australian
Standards may be obtained from:
PO Box 1055
Strathfield NSW 2315
Health Statistics: The Australian Institute of Health and Welfare is
Australia's national agency for health and welfare statistics and information.
The Institute works with many government and non-government bodies across
the nation to generate reliable, regular and current facts and figures
on the health and welfare of Australians. It publishes reports and discussion
papers, drawing on a wide range of data collections, and also develops
and publishes standards and classifications for health and welfare statistics.
Australian Institute of Health and Welfare
6A Traeger Court, Fern Hill Park, Bruce ACT, Australia
GPO Box 570, Canberra ACT Australia 2601
The U.S. Commercial Service in Australia
Contact: Ms. Monique Roos, Commercial Specialist
Level 59, MLC Centre, 19-29 Martin Place
Sydney NSW 2000