Tag Archive for: clinical trial exemption

China Releases Draft Clinical Evaluation Exemption List for 2022

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On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.

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China’s NMPA Updates Medical Device Classification Catalogue

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China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.

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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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