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Source: Australian Therapeutic Goods Administration

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Due to COVID-19 pandemic and delays in EU MDR implementation

13 October 2020

Description

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 due to COVID-19 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.

  • Background
  • Purpose and scope of this guidance document
  • Terminology
  • Lapsing of CADs
  • Suspension/cancellation/revocation of a CAD (rather than lapsing)
  • What the TGA expects from sponsors in relation to lapsing

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