Home Insights No CE mark? No problem.

No CE mark? No problem.

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia.

Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device or IVD on the ARTG. Waiting for the European CE mark to be granted often resulted in delayed entry of devices into the Australian market.

In August 2018, a change was made to the legislation that permits the TGA to accept certification from a number of other markets with similar regulatory systems.  Acceptable certification includes decisions of the United States Food and Drug Administration (US FDA), approvals and licences issued by Health Canada, pre-market approvals from Japan and Certificates and reports issued under the Medical Device Single Audit Program (MDSAP).

The change has removed the reliance on the European notified bodies’ EC certificates, providing greater flexibility for sponsors, especially those based in North and South America.

If you’re looking at bringing a medical device to Australia the absence of a CE mark may no longer be an issue.

If you need assistance with medical devices in Australia, please contact our Regulatory Services team.