Introduction

The Therapeutic Goods Amendment (Medical Devices) Bill 2002 received Royal Assent on 4 April 2002 and will be implemented from 5 October 2002.

The amendment Bill:

• Sets out the new regulatory scheme for medical devices which is internationally accepted best practice, based on the guidelines of the Global Harmonisation Task Force (GHTF) and the European Community (EC) requirements.
• Makes no change to the regulatory regime for medicines.
• Retains Australia's sovereignty by providing a choice to accept or reject future changes, eg: new standards.
• Continues to regulate the quality and safety of therapeutic goods not covered by the EC system, eg: tampons and disinfectants.
• Provides for a transition to the new scheme over 5 years.

The approach

The approach used to develop the new legislation has been to:

• Develop a new separate Chapter in the Act for the new scheme rather than modify the existing regulatory regime for devices:
  • the new scheme is very different to the current Australian approach; and
  • the new scheme is a complete and integrated system.
• The new Chapter for medical devices sets out the new requirements, and then provides broad powers to implement the requirements through administrative arrangements, with penalty provisions as a last resort.
• Retain the current regime for the regulation of 'therapeutic devices' (the term used in the current Act) when adding the new scheme for the regulation of 'medical devices' (the new term as used in the EC scheme).
  This means that the regulation of devices will be a two-part scheme - one part regulating therapeutic devices and the other part medical devices.
• Only one set of Australian regulations will apply to any one product at any one time. The advantages of this approach are:
  • Australia can continue to regulate the quality and safety of therapeutic goods not covered by the EC system. eg: tampons and disinfectants;
  • the current legislation deals with both medicines and devices and will continue with minimal change and disruption; and
  • a smoother transition to the new scheme is achieved.
• Provide for a transition to the new scheme over 5 years starting 5 October 2002. Medical devices will progressively move to the new scheme:
  • from 5 October 2002 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; and
  • medical devices currently in the Australian Register of Therapeutic Goods will have until 4 October 2007 to move to the new scheme.
• Make no changes to the regulatory regime for medicines:
  • the current legislation deals with both medicines and therapeutic devices and will continue with minimal change and disruption.

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Some important features of the new legislation

• The new scheme contains a complete and integrated approach dealing with:
  • the classification of medical devices - Class I, IIa, IIb, III and Active Implantable Medical Devices (AIMDs);
  • the essential principles for safety and performance with which all medical devices must conform;
  • conformity assessment procedures to ensure medical devices meet the essential principles for safety and performance;
  • demonstrated compliance with nominated international standards as a basis for presuming that a medical device conforms with the essential principles; and
  • obligations imposed on manufacturers and sponsors.
• Under the new scheme the major elements of the current legislation will be retained but the emphasis will be different. One way to view the current Act is to see it as built around 4 pillars - standards, administrative arrangements (the ARTG), manufacturing and advertising. The module in the Act that is to contain the new scheme will still be based on the 4 pillars. The position under the new scheme with the 4 pillars will be:
  • 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;
  • The ARTG - most of the administrative requirements in Part 3 of the Act will continue to be used for the new scheme. Medical devices will no longer be 'registered' or 'listed' but applications and entry in the ARTG will still be required. The cancellation of entries, recalls, etc, will be much as it is now. Provision will be made for applications for entry on the ARTG to be lodged electronically using the Device Electronic Application Lodgement system (DEAL);
  • Manufacturing - because the regulation of manufacturers is integrated into the new system, Part 4 of the Act dealing with manufacturing does not need to apply to medical devices under the new scheme. However, the major features of the current regulation of manufacturers will be retained but in a different guise, eg: declarations of conformity will be issued, audits will be conducted, etc.; and
  • Advertising - the current advertising requirements will continue to apply to medical devices regulated under the new scheme.
• Post-market - under the new scheme there will be a greater emphasis placed on postmarket activities, such as vigilance.
• Sponsor and Manufacturers - as with the current regime, responsibility for the safety and performance of medical devices will primarily rest with sponsors and manufacturers.

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