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Use of third party conformity assessment bodies for medical devices supplied in Australia
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This consultation closed on 27 March 2009.
23 November 2009
The following letter was sent to stakeholders on 10 November 2009.
Update on Consultation re Use of Third Party Conformity Assessment Bodies for Medical Devices Supplied in Australia
The Therapeutic Goods Administration (TGA) has received many submissions from stakeholders in relation to the consultation paper which closed earlier this year on the Use of Third Party Conformity Assessment Bodies for Medical Devices Supplied in Australia. These submissions are currently being considered and the TGA is working on a response paper.
Subsequent to the TGA's release of its consultation paper, the Government announced a review of all aspects of the Commonwealth's Health Technology Assessment (HTA) processes. Given the scope of this review includes some areas of the TGA's assessment processes, the TGA considers it would be premature to proceed with a response to the issues raised in its consultation paper on the use of third party conformity assessment bodies ahead of the HTA Review being finalised later this year.
Once the HTA Review is finalised the TGA proposes to proceed with the release of a response, taking into account the comments and submissions received. Stakeholders will be kept informed as this matter is progressed.
Dr Larry Kelly
Office of Devices Blood and Tissues
19 December 2008
Australia regulates the quality, safety and performance of medical devices in accordance with the framework established by the Global Harmonization Task Force (GHTF) for the regulation of medical devices.
Inclusion of a medical device on the Australian Register of Therapeutic Goods (ARTG) allows a medical device to be legally supplied in, or exported from, Australia. To be included in the ARTG the TGA requires applicants to hold, or have access to, evidence that the conformity assessment procedures applied by the device manufacturer demonstrate compliance with the Essential Principles, including evidence that the manufacturer's quality system has been accredited to an acceptable standard. The evidence is produced in a form termed a conformity assessment certificate and the body issuing the certificate is referred to as a Conformity Assessment Body.
The Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 specify that the TGA is responsible for issuing conformity assessment certificates for devices in two circumstances:
- where the device contains a medicinal component and/or materials of animal, biological or microbial origin or recombinant equivalents of these substances - referred to collectively in this paper as 'designated materials', and
- where the device is manufactured in Australia (other than low risk or Class I).
Where the device is not made in Australia and it does not contain a medicine or a designated material then bodies other than the TGA may issue conformity assessment certificates. These certificates are provided to the TGA as evidence to support the inclusion of the device in the ARTG.
The TGA's exclusive role in issuing certificates to Australian manufacturers has been questioned over a number years by the medical devices industry sector, which sees this requirement as an unfair restriction on Australian manufacturers relative to overseas manufacturers. This position has been articulated most recently in the Productivity Commission's Annual Review of Regulatory Burdens on Business: Manufacturing and Distributive Trades, which was released in August 2008.
The TGA's role in issuing conformity assessment certificates to Australian manufacturers was to have been considered as part of the establishment of the Australia New Zealand Therapeutic Products Agency (ANZTPA). Although the establishment of ANZTPA has been postponed, the Government has flagged its intentions to discuss options for enabling bodies other than the TGA to issue conformity assessment certificates for those devices required by current legislation to have TGA-issued certificates.
The present paper outlines the principal issues to be considered in relation to use of third party conformity assessment bodies for assessment of medical devices or manufacturers.
Invitation to comment
The TGA will use the submissions and input received to help inform future regulatory directions.
Once the consultation period has closed, the TGA will continue to work with stakeholders to develop a preferred option or options. There will be further consultation and an opportunity to comment based on these options before a final direction in relation to the use of third party external assessment bodies for conformity assessment of medical devices supplied in Australia is formulated.
The TGA held two consultation workshops. As part of its formal consultation process (see above) on the use of third party conformity assessment bodies for medical devices supplied in Australia. The first was held in Sydney on 17 March 2009 and the second in Melbourne on 18 March 2009. Both workshops were well attended. The half-day workshops provided stakeholders with an opportunity to hear a range of viewpoints and to share their own perspectives.
Presentations at the workshops included two international guest speakers - Dr Dan Schultz from the US Food and Drug Administration, and Mr Rob Higgins from the UK Medicines and Healthcare Products Regulatory Agency. Presentations were also made by the TGA and Mr Gus Taddeo, Chair of the Board, Medical Technology Association of Australia, and Managing Director, Cook Australia, and Ms Naomi Riedel, Managing Director of TÜV Rheinland Australia Pty Ltd.
Once the consultation period has closed, the TGA will consider submissions and continue to work with stakeholders to develop a preferred option or options. There will be further consultation and an opportunity to comment based on these options before a final direction in relation to the use of third party external assessment bodies for conformity assessment of medical devices supplied in Australia is formulated.