Tag Archive for: clinical trial

Registering Innovative Medical Devices in India

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Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.

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China NMPA Adds 47 Products to Clinical Trial Exemption List

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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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CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

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As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.

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