China update – regulation with a European sauce?
CFDA continues to propose more changes to medical device regulation, and as ever the agency looks to international practices and seeks to weave them in to China requirements.
A recent consultation on proposed updates to Order 650 (the primary Medical Device regulation) canvassed a number of changes which have a distinctly European flavour and profound impact in importers and domestic manufacturers alike. The proposed changes include:
- CFDA to handle all Class II registrations centrally including both domestic and international manufactured. This would be a profound change. Currently domestic manufacturers enjoy the option to take Class II registrations to their local Provincial FDA, where fees are lower or non, existent, processing is much faster and assessments less rigorous. It’s a common strategy for international manufacturers to establish local manufacturing in China to take advantage of this much cheaper path to market for medium risk devices. If this proposed change becomes law it would close this door to international manufacturers (and to all their domestic competition as well). Such a change would also have profound implications for CFDA, in that it would involve a massive increase in workload. Which brings us to…
- CFDA to approve third party assessors The draft proposes amending Article 8 to allow CFDA to “authorize review and evaluation by qualified assessment agencies”. This looks and feels like the European approach of use of Notified Bodies to do assessments (a practice also used in Japan and Canada for medium risk medical device Assessments, and now being contemplated in Australia). Given the current environment in China, with hot news scandals around tainted vaccinations there’s strong pressure for increased central control of regulation, so it does seem that this is a proposal that may face some headwinds.
- Increased responsibilities for local authorised representatives. In-China sponsors conducting filings on behalf of international manufacturers will have more stringent oversight under proposed changes which will require the sponsors to take direct responsibility for ensuring correct adverse event reporting and management of postmarket actions including recalls and also to accept joint and several responsibility for product liability. That’s a direct copy from the new requirements for EC Authorised Representatives under the European Medical Device Regulations.
- Outsourced Production is explicitly permitted An aspect of China regulations is that the manufacturer is assumed to carry out production directly, which is, of course, not the reality of a global industry. The new regulations would explicitly permit a manufacturer to outside production to other parties. Essentially this is introducing the European concept of a Legal Manufacturer to China regulations.
- All Class II devices exempt from in China clinical trials If enacted, this would also have profound implications for Class II device manufacturers, many of which are still required to be supported by direct in-China clinical trials. The draft stipulates that Class II devices would In Principle not require China clinical trials. it remains to be seen how those principles would be applied in practice.
Some of these changes are profound and new, whereas others reprise proposals which have been on the table for some time in China. The changes continue CFDA’s efforts to internationalise their regulations with more borrowings from overseas practice. The consultation period closed on 25 July. It remains to be seen which of these amendments will see the light of day and become actual law. Interesting times indeed.
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