You are here
The TGA's approach to delays in medical device conformity assessment recertification
Download pdf - 167.41 KB
Download docx - 88.48 KB
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.
Contents
We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.