Why do we need to reform the regulatory system?

• Australia's medical device industry is valuable to Australia - a $1.5 billion industry in 1996 (Industry Commission report).
• Australia needs to keep pace and harmonise with international best practice if we are to protect our international reputation as a country that manufactures, uses and exports high quality medical devices.
• The future prospects of the Australian medical devices industry depend on avoiding unnecessary or onerous regulation which would make Australian access to international markets uncompetitive.
• It's in all our interests to maintain public health and safety, consumer confidence and a world class medical device industry.
• Australia is one of the five members of the medical device Global Harmonisation Task Force (GHTF) together with the USA, Canada, the European Union and Japan. The GHTF views harmonisation as a way to define common regulatory approaches for medical devices at an international level.
• Consumers, industry and the Government want better and faster market access.

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Are these changes related to the Mutual Recognition Agreement (MRA) with the European Union?

Yes. In June 1998 Australia signed an MRA with the European Union, which paved the way for a 'harmonised' regulatory system.

These new changes incorporate elements of the European regulatory requirements, but not the European private sector evaluation system. The changes will also adopt the essential principles of quality, safety and performance, vigilance requirements and the use of international standards as recommended by the GHTF.

What are the main changes?

The medical device classification and premarket assessment requirements will be different.

• Most medical devices will be classified into one of five classes (I, IIa, IIb, III and Active Implantable Medical Devices - AIMDs). All classes will comply with a minimum requirement for safety and performance and be included in the ARTG. Applications for entry on the Australian Register of Therapeutic Goods can be lodged electronically using the Device Electronic Application Lodgement system (DEAL).
• The new regulations are based on the 'intended purpose' of the medical device, and allow for new technologies.
• Many medical devices that are currently listable (eg. thermometers, gauze dressings and stethoscopes) will become Class I devices.
• Other listable medical devices (eg. hearing aids, dental filling materials and oxygen meters) will become Class IIa devices.
• High risk listable and registrable medical devices will become Class IIb and III devices.
• All classes will be required to demonstrate their conformity with safety and performance requirements. Class IIa, IIb, III and AIMD devices will require quality systems. Class III devices and AIMDs are subject to the most extensive premarket assessment in the new regulatory system in Australia.
• Many exempt medical devices will become Class I (eg. non-powered hospital furniture, simple non-sterile non-powered surgical and dental instruments).
• The TGA will continue to consult on the inclusion of in-vitro diagnostic medical devices in the new regulatory system.

Postmarket requirements

• Sponsors must advise the TGA of serious public health threats or concerns within 48 hours, incidents involving serious injury or death within 10 days and non serious incidents within 30 days.
• The requirement for periodic inspection of manufacturer's quality system under the new regulatory system will be essentially similar to the current licensing system.
• Sponsors of all medical devices marketed in Australia must comply with labelling and advertising requirements.

Compliance with product and manufacturing requirements

• Compliance with the safety and performance principles will be mandatory.
• Compliance with internationally harmonised standards will indicate conformity with the essential principles for quality, safety and performance.
• Standards - standards will continue to be Gazetted but will not be mandatory. Compliance with the relevant Gazetted standards will lead the Secretary to presume that the medical device meets the essential principles of safety and performance.

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Who will the reforms affect?

Australian manufacturers, importers, exporters and/or distributors of medical devices will all be affected by these changes.

Do I still need to comply with the new requirements even if I don't export my goods?

Yes.

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 differing regulatory requirements in different countries.

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.

Only one set of Australian regulations will apply to any one product at any one time.

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
• People who are deaf or have a speech or hearing impairment and have access to TTY may call 1800 500 236 within Australia.