Open consultations & reviews
The TGA welcomes comments on the following open consultations and reviews.
- Consultation: Alignment with European medical device regulatory framework: Up-classification of surgical mesh & Patient implant cards
The TGA is seeking comments on proposed changes to up-classify all surgical mesh medical devices to Class III & to provide patient implant cards (and consumer product information) for all implantable medical devices. Closing date: 25 August 2017
- Consultation: Nomenclature of Biological Medicines
The TGA is seeking comments from interested parties on proposed options on whether there is a need in Australia for additional naming requirements for biological medicines as a way of strengthening traceability and pharmacovigilance. Closing date: 8 September 2017