Submissions received: Designation of Australian conformity assessment bodies for medical devices

13 June 2017

The TGA would like to thank respondents who provided submissions in response to the November 2016 public consultation paper, Consultation: Designation of Australian conformity assessment bodies for medical devices.

A total of 12 submissions were received. Of those submissions, 9 were from industry and regulatory consultants, 1 from an industry representative group and 2 from a health professional group.

All submissions that gave permission to be published on the TGA website are now available below in PDF format.

Submissions

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TGA response

Submissions received in response to the public consultation showed broad stakeholder support for Australian conformity assessment bodies undertaking conformity assessment for all medical devices, including high risk, subject to the scope of designation approval.

The framework for conformity assessment bodies may draw from current European arrangements for notified bodies and the Medical Device Single Audit Program requirements. Stakeholder comment noted these frameworks as the source for detailed requirements.

Stakeholders noted the importance of competitive neutrality in the implementation of Australian conformity assessment bodies and there was concensus that designation fees should be charged on a cost recovery basis with individual conformity assessment bodies able to determine their own fees for conformity assessment certification.

Stakeholder feedback will be included in developing a policy position for future changes to the Therapeutic Goods Regulations 1990.

Further information on process details of the designation of conformity assessment bodies in Australia that has been informed by this consultation will be included in guidance documentation, to be released on the TGA website closer to the implementation date of 1 January 2018.