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IMDRF consultation: Principles of labelling for medical devices and IVD medical devices

13 August 2018

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 TGA (together with all other working group members) invited interested parties to comment on the document.

Deadline for submissions

Interested parties responded directly to the working group chair (Ms. Melissa Torres) by 12 September 2018.

Do not send your responses to the TGA.

Instructions on making comments and any enquiries are included on the IMDRF website linked above.

Further information about IMDRF consultations

Further details about current (and closed) consultations, including how to make submissions, are available on the Consultations page of the IMDRF website.