Jun 8, 2021

Australia’s Therapeutic Goods Administration (TGA) has announced that corporations based inside the country may apply to become Australian Conformity Assessment Bodies (AU CABs) beginning on July 1, 2021. Candidates for this status should be able to demonstrate competence and recognition for medical device conformity assessment and quality management system (QMS) auditing.

Australian Conformity Assessment Body (AU CAB) designation should support timely approvals

Australian regulations currently require medical device manufacturers to acquire a conformity assessment certificate before their products can be placed in the Australian Register of Therapeutic Goods (ARTG). The certificate may be issued by the TGA or an overseas Notified Body. Given that the TGA’s estimated timeframe for completing such an assessment is 255 days, the agency perceives a need for expanding the numbers of bodies issuing certificates and thus expediting the process. The TGA has already held a consultation for this initiative, the details of which it published in November 2016.

An AU CAB is expected to operate under systems and controls that have already been assessed as compliant by comparable overseas regulators through their parent and affiliated organizations. These regulators include EU Notified Bodies designated under the MDR or IVDR, as well as Auditing Organizations (AOs) recognized through the Medical Device Single Audit Program (MDSAP).

TGA guidance coming soon on AU CAB operations

The TGA plans to publish application instructions, an online application form, and guidance addressing both the criteria for designation and the scope of medical devices for which an AU CAB can issue a conformity assessment certificate. The TGA will retain sole responsibility for adding medical devices to the Australian Register of Therapeutic Goods (ARTG). The role of the AU CAB has already been laid out in legislative and regulatory amendments.

More resources on Australian medical device regulation from Emergo by UL:

Author

  • Timothy Herr

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