What are medical devices?

A 'medical device' is:

• 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 or is to be supplied, to be used for human beings for the purpose 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; or
  • control of conception,
  and that 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.

Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, X-ray equipment, heart rate monitors, surgical lasers, pacemakers, dialysis equipment, baby incubators and heart valves.

Why do we regulate medical devices?

Formal arrangements for regulating medical devices commenced in February 1987 in response to community 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.

Medical devices are not consumer goods. We mainly use medical devices because we have to - and our health can depend on them. Consumers and industry alike deserve confidence in the medical devices being used in Australia.

It's in all our interests to maintain public health and safety, consumer confidence and a world class medical device industry.

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Who regulates medical devices?

Before any medical device can be supplied in Australia, details must be included in the Australian Register of Therapeutic Goods (also referred to as the ARTG).

Suppliers of medical devices in Australia, apply to the Therapeutic Goods Administration which assesses applications and maintains the ARTG.

There are currently approximately 24,000 product entries in the ARTG for medical devices (as at May 2002).

Why do we need to reform the regulatory system?

• The Australian medical devices industry plays an important part in our health sector and the Australian economy generally - a $1.5 billion industry in 1996 (Industry Commission report).
• Australia is amongst the world leaders in ensuring high standard international regulation and is one of the five members of the Global Harmonisation Task Force (GHTF) for medical devices (alongside the USA, Canada, the European Union and Japan).
• Australia needs to keep pace and harmonise in accordance with the highest international standards to protect its international reputation as a country that manufactures, uses and exports high quality medical devices.
• The future prospects of the Australian industry depend on avoiding unnecessary or excessive regulation which would make Australian access to international markets uncompetitive.

What are the main changes?

Most medical devices will be classified into one of five classes (I, IIa, IIb, III and Active Implantable Medical Devices - AIMDs).

• Each device class will have minimum requirements for safety and performance that must be met.
• Provision will be made for applications for entry on the ARTG to be lodged electronically using the Device Electronic Application Lodgement system (DEAL).

When will the new system come into force?

The new harmonised system will be effective from 5 October 2002.

After that time all new medical devices will be required to comply with the new harmonised requirements, except a small group of products, such as the currently exempt products, which will have until 4 October 2004 to meet the new requirements.

All medical devices currently approved for use in Australia will have five years (until 4 October 2007) to comply with the new requirements.

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Who will the reforms affect?

The reforms will directly affect Australian importers, exporters and manufacturers of medical devices.

How will the general public benefit from these reforms?

Consumers will benefit from:

• The confidence of having comprehensive quality and performance requirements applied to all medical devices used in Australia.
• The faster, streamlined approach to regulation providing timely access to new and safer technologies as they come onto the world market.

How will the medical devices industry benefit from these reforms?

Australian industry will benefit from:

• Easier access to overseas markets;
• Timely access for innovative products;
• More transparent regulation; and
• Removing the duplicate costs of having to meet different regulatory requirements in different countries.

How does the new system compare with other countries?

The new system is based on the principles and guidance documents agreed by the GHTF. Other comparable countries are adopting a similar "harmonised" approach to the regulation of medical devices.

Where can I get more information?

There are many ways for you to obtain more information and assistance with the transition to the new medical devices regulatory system:

• Talk to your industry association (eg. the Medical Industry Association of Australia Inc, Australian Dental Industry Association, Australian Chemical Specialities Manufacturers Association, Australian Diagnostic Manufacturers Association, Diagnostic Imaging Association of Australasia, Australian Health Industry Inc.);
• Visit the medical devices page on this website
• Telephone the Therapeutic Goods Administration (TGA) on 1800 020 653 (or +61 2 6232 8438 if calling from overseas);
• Write to Office of Devices, Blood and Tissues, TGA at PO Box 100 Woden ACT 2606; or
• Send an email message to: cab.medical.device.information@tga.gov.au
• Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
  • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
  • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653