Over the course of 2016, we’ve been inundated with information around the introduction of the Medical Device Regulation (MDR) in Europe, new revision of ISO 13485, Brexit, and the implementation of MDSAP. Australia has continued to work under the existing arrangements, which rely heavily on recognition of CE certificates granted under the current Medical Device Directives, but how long can this last? The Australian Therapeutic Goods Administration TGA publishes annual statistics of performance. These provide a fascinating insight into the agency’s workload and the extent of reliance on European certification. How will TGA manage in the face of the big changes in Europe?
Archives for December 2016
TGA is currently seeking feedback on some far reaching regulatory reforms, including proposals to introduce local third party assessment arrangements and direct recognition of regulatory approvals from “comparable” overseas regulatory agencies. TGA currently only recognises European certifications. These reforms could see Notified Bodies operating directly in Australia and TGA recognising decisions from agencies such as the US FDA, Health Canada or the Japanese PMDA.