Regulatory Landscape for Digital Health Technologies in China

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Regulatory Landscape for Digital Health Technologies in China

Digital health technologies have become a focus for investors in the healthcare industry in China. The NMPA has set various laws and policies regulating digital health technologies. The NMPA considers digital devices such as healthcare apps, wearables, and Software as a Medical Device (SaMD) as medical devices under the Medical Device Regulation (Order #739). Manufacturers must follow the registration process accordingly.