Australia TGA Plans for Brexit


The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia.

Australia's Therapeutic Goods Administration (TGA) have published their plans in the event of either Brexit "no deal" or "deal"/exit extension in the field of medical devices.

Brexit "no deal"

In the event of a 'no deal' exit of the United Kingdom (UK) from the European Union (EU), the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia.

If there is a 'no deal' Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG:

  • Medical devices currently included in ARTG may continue to be imported and/or supplied in Australia with the current certification issued by UK notified bodies, which are subject to continuing MHRA oversight.

  • Two instruments will be amended to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies:

  • The Therapeutic Goods (Overseas Regulators) Determination 2018 will be amended to include recognition of notified bodies granted ongoing legal status by the MHRA.

  • The Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 will be amended to specify the conformity assessment documents issued by UK notified bodies that may accompany an application for inclusion in the ARTG

Brexit "deal"/exit extension

Under the proposed Brexit 'deal', UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will be no immediate impact on manufacturers certified by these notified bodies. Sponsors of these devices can continue providing these certificates as conformity assessment documents for their medical devices in Australia. Similarly, if the time frame for the exit of the UK from the EU is extended, current arrangements will continue until an exit occurs.

For more information, check out the following link:

- Australia TGA

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