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This consultation closed on 12 September 2018.
The International Medical Device Regulators Forum (IMDRF) working group on Good Regulatory Review Practices seeks to promote a globally harmonised approach in premarket review processes. Their current Work Item is to develop a common set of competency, training, and conduct requirements for regulatory reviewers that perform premarket reviews/assessments of the technical documentation of a submission/design dossier, and is intended to develop confidence in the consistency of regulatory reviews across jurisdictions.
This IMDRF working group sought comments from interested parties on the following proposed document:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.