Australian Regulator Prepares for the Brexit Fallout

28 March 2019 |


Following our earlier article Fog in the Channel: a European Medtech Perspective on Brexit where we outlined the need for the EU and UK to manage the pending fallout of Brexit, the Australian regulator, the Therapeutic Goods Administration (TGA) has seen the approaching storm and is looking to put necessary arrangements in place to reduce the impact of product markets in Australia, under an existing CE certificate.

The Australian regulator has always relied heavily on European Approvals which is evidenced through the statistics which suggests ~80% of products are imported using CE certificates under the existing Medical Device Directive (MDD).

Australia recognised the issue specifically around the UK Brexit, there will be a substantial impact to those notified bodies who currently reside in the UK. Once Brexit is finalised, it’s likely those notified body issued certificates will no longer be valid. In Australia, the Sponsor (person legally responsible for products on the Australian market) must have a valid certificate of conformity available.

In the event no deal is reached between the UK and EU, the TGA will implement arrangements to provide for minimal interruption in the supply of medical devices in Australia. This will result in the acceptance of certificates from UK based notified bodies until 2020.

With a number of notified bodies relocating to the EU, there is a change or update that’ll be required with existing registrations. This results in an update to the manufacturers’ evidence, and potentially change to the existing ARTG (which can attract a fee).

Although this will provide some “smooth sailing” for local sponsors, it’s imperative that your existing registrations are monitored closely and prepare early for any unforeseen issues.

If you need assistance in navigating the changes, or with any of your registrations, be sure to reach out directly for an obligation free conversation.

Help button-Quick Call-Brandwood BiomedicalWe offer deep support for manufacturers navigating European and other international regulatory processes. Whether it’s a strategy for MDR transition, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us for a free, no obligation discussion.  Email [email protected] or call us: 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)


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