China's Medtech Regulatory Update Does Not Go Far Enough For Overseas Innovators

Law firm claims playing field is still far from level

Foreign medical device innovators accessing the Chinese market remain at a disadvantage to local companies, even after the recent regulatory pathway revision.

China globe

The latest revision to China's Regulation for Supervision and Administration of Medical Devices (RSAMD) – State Council Order No 739 – does not do enough to help foreign medtech innovators gain access to the Chinese market.

That is the contention of law firm Ropes & Gray, in a whitepaper compiled after the “2021 Medtech Regulatory Affairs Roundtable,” hosted jointly by the law firm and the consultancy...

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