Australia consults on third-party conformity assessment
This article was originally published in SRA
Australia’s Therapeutic Goods Administration may begin allowing third-party conformity assessment bodies to examine and certify the quality systems of local medical device manufacturers1. To that end, it has released a consultation document that outlines the principal issues to be considered, the most important of which is determining an appropriate balance in the use of CABs to ensure the timely availability of safe and effective medical devices2. Comments are due by 27 March.
The move will likely be welcomed by the Australian medical device industry, which has long urged the TGA to end its exclusive role in issuing conformity assessment certificates by opening the doors to CABs.
In addition to submitting comments, stakeholders can participate in a related workshop that the regulatory authority plans to hold as part of the consultation process. Thereafter, the TGA will work with stakeholders to develop a preferred option or options. There will be further consultation on these options before a final decision is made on the issue.
CABs and the TGA’s role
The agency wants to ascertain whether the use of CABs should be allowed in Australia, and the TGA’s role, if any, in the conformity assessment process. For example, it wants to know if CABs should be permitted to issue certificates or just review reports to be assessed by the TGA, who would issue a certificate on the basis of these reviews.
Other issues at stake include whether the legislation should specify that external bodies undertaking assessments should be resident in Australia and the role of the TGA in accrediting these external bodies.
Also, the TGA wants to know whether these external bodies should be excluded from issuing certificates for certain classes or types of devices, such as high-risk devices. In the consultation document, the TGA refers to concerns raised in the European Union about the working of the European CABs, identifying room for improvement.
[Discussions on a proposed recast of the European medical device directives resulted in stakeholders suggesting that the designation and monitoring of notified bodies or CABs should be tightened to ensure high levels of competence3. Another proposal by the European Commission is to transfer the responsibility for conformity assessments for higher-risk devices from CABs to a supranational authority and for the latter to make recommendations for consideration by the various national regulators.]
TGA’s exclusivity criticised
The TGA is presently responsible for issuing conformity assessment certificates for all devices that are manufactured locally - other than Class I (lowest-risk devices) - and those containing materials of animal, biological or microbial origin or recombinant equivalents of these designated materials.
The regulations allow the TGA to accept conformity assessment certificates issued by CABs in relation to devices manufactured outside Australia if they do not contain the designated material. More than 97% of applications for inclusion of medical devices in the Australian Register of Therapeutic Goods are supported by European CE certificates issued by one of the 78 notified bodies operating in Europe.
The TGA’s exclusivity over issuing such certificates for locally manufactured devices has been long criticised by Australian manufacturers, who feel that the practice puts them at a relative disadvantage in relation to overseas manufacturers. The industry’s stand was articulated most recently in the Productivity Commission’s annual review of regulatory burdens on business, which was released in August 20084.
The TGA has issued 156 conformity assessment certificates to 102 Australian manufacturers since October 2002, of which 127 were for low- to medium-risk devices. Certificates for 21 new Australian manufacturers are currently under review. “Certificates for Australian manufacturers make up 1.5% of the conformity assessment certificates that support device inclusions in the ARTG,” the TGA said.
The TGA’s role in issuing conformity assessment certificates to local device manufacturers was to be reviewed as part of plans to establish the ANZTPA, a joint regulatory agency for Australia and New Zealand, but that project is now on hold.
References
1. TGA, Consultation announcement, 22 December 2008, www.tga.gov.au/devices/drthirdparty.htm
2. TGA, Consultation: Use of third party conformity assessment bodies for medical devices, 22 December 2008, www.tga.gov.au/devices/drthirdparty.pdf
3. The Regulatory Affairs Journal - Devices, 2008, 16(4), 272-273
4. The Regulatory Affairs Journal - Devices, 2008, 16(6), 407-408