While this may seem a bread and butter administrative efforts, in another way they represent a radical change – with China for the first time taking the lead on IMDRF harmonization efforts
CFDA’s own press release on the standards work item is illuminating. It talks of Chinese leadership in use of standards and efforts to achieve global harmonisation of approaches.
…a historic breakthrough since China has changed its role from a participant to a leader in the rule making of international standards recognition in the medical devices area. It also marks new progress made by China in continuously and in-depth promoting the Chinese experience in medical device standards management.
This new work item proposed by
China will update the list of international standards recognized by IMDRF members since 2014 and further analyze the similarities and differences in related policies and techniques of members when they adopt or recognize international standards.The intended research results of this proposal will lay a solid foundation for exploring the best practice of international standards recognition,promoting mutual recognition of standards and achieving the harmonization of international medical devices regulation.
Of course the current practice is far from harmonised, with many local variants on international standards, and no more so than in China, where local requirements – and local testing have been the norm.
This needs to be put in context of ongoing domestic reforms in China. Late in 2017 CFDA announced proposals for acceptance of international test data – but maintained requirements to meet China specific standards. However, throughout 2017, the reality was much turbulence with regard to the China type testing. The abolition of type testing fees in March resulted in a go slow in test activity, effectively stalling the introduction of new products to the China market. In January this year we saw the CFDA then having to be quite forceful, issuing an edict to Test Centres to listen to manufacturers and to reopen the gates for new type testing . This included reopening the option of laboratories charging for type testing.
smooth the complaint channels… earnestly listen to the relevant demands of manufacturers … understand the practical difficulties and use initiative.
… accept applications from outside the province… include specific inspection time limits in the contract, completing testing within reasonable time … correct issues promptly…
So, once again, companies can now approach the specific type test centre and make necessary arrangements, including agreed fees, to have the type testing done. Proof is yet to be seen as to exactly what the costs are, and how quickly the testing can be completed. But the reopening should improve opportunity for international companies to enter China.
And China is looking to reform its basic Device Law, Order 650, to introduce a range of other changes – including acceptance of international clinical trial data. (See here for our training video on these changes).
But back to IMDRF and China’s new work items…
At face value – this appears to be about IMDRF members recognising international consensus standards and practices – which is exactly what harmonization is meant to be all about. But let’s go back to that press release again. CFDA talks specifically about “promoting the Chinese experience in medical device standards management”. The big challenge for anyone tackling Chinese Type testing is that the local standards often include China specific requirements, which can often be idiosyncratic. To be fair to CFDA, they are also running a massive program of upgrade of China domestic standards to become more closely aligned with ISO/IEC norms. But it remains to be seen if CFDA will also be pushing some of China’s expectations and practices into the global arena.
Yes – China remains complex and difficult. But the beneath the current turmoil, there are real efforts to reform and internationalize the Chinese regulatory process. What is very obvious, is that at the same time that western economies are scaling up regulation and making the introduction of new and existing products ever more difficult, on the other side of the world, China is starting to find ways to expedite and simplify the introduction of new technologies to the fastest growing market on the planet.
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