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China Medical Device Regulation

Meaning

China Medical Device Regulation encompasses the comprehensive set of laws, administrative regulations, and technical standards established by the Chinese government, primarily through the National Medical Products Administration (NMPA), for medical devices. These regulations govern the entire lifecycle of a medical device, including research, development, clinical trials, registration, manufacturing, and post-market surveillance. For devices utilized in hormonal health diagnostics or therapies, strict adherence to these rules is mandatory to ensure patient safety and product efficacy within the Chinese market. Compliance dictates the commercial viability and clinical accessibility of advanced wellness technologies.