China continues to grow and interest remains as active as ever. Grant Bennett takes a look at the China regulatory pathway and the challenges along the way.
Over the past several months, we’ve been discussing at a high level, the upcoming changes for manufacturers considering the introduction of the Medical Device Regulations (MDR), along with the implementation of the ISO 13485:2016 and MDSAP. In this article, we’ll discuss more specifically section 8.2.2 Complaint Handling requirements under the 2016 revision of the standard which has a 3 year transition.
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?
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.
The US FDA has amended the definition of custom medical devices to improve industry compliance. The updated definition seeks to clarify a 2014 guidance after it became apparent that some manufacturers were distributing medical devices as custom devices despite not meeting the statutory requirements.
In Australia, TGA has specific requirements for postmarket compliance which extend far beyond conventional adverse event reporting. We take a look at the bigger picture.