China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.
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For medical device registration in China, one of the most important documents to be provided is clinical data.
The changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.
Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.
China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster.