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The Therapeutic Goods Administration (TGA) is issuing this guidance to inform sponsors (and, where relevant, manufacturers) about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits as a result of the COVID-19 pandemic, the transition in Europe to their new regulations, and the limitations on the current number of notified bodies designated under the European Medical Devices Regulation (MDR).
This guidance applies to both overseas and Australian conformity assessment documents. However, where there is a need to distinguish between the two, we use more specific terms.
This guidance is not legislative in nature and is subject to the requirements of the therapeutic goods legislation. The exact approach taken by the TGA will depend on the facts of the case and the relevant legislative provisions.
Notifying the TGA of lapsing medical device conformity assessment certification
To notify the TGA of a lapsed or lapsing medical device conformity assessment certification please complete the notification form on the TGA Consultation Hub. There is no fee associated with notifying the TGA. Guidance on how to complete the notification form is available in the ‘Supporting documents’ section below.