Conformity Assessment limitations to be removed for Australian manufacturers of medical devices
The following announcement was made in October by the Therapeutic Goods Administration: ‘New regulations will be introduced to allow Australian manufacturers to obtain market app
TGA Release Proposal Paper: Are Tighter Controls and Alternative Options for Conformity Assessment Ahead?
The TGA have released a proposal paper introducing changes which could shake things up for Australian and overseas medical and IVD device manufacturers. The paper explores changes