
China’s Regulatory Approach to Software as a Medical Device (SaMD): GMP & Inspection Guidance
To respond to the emerging trend of adopting software in health care, China has told its regulators what to look for when approving software and
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2026 China NMPA Bluebook is here:

To respond to the emerging trend of adopting software in health care, China has told its regulators what to look for when approving software and

The NMPA released three guidelines in a single day, March 9, 2022 in an effort to regulate and support the rapid development in digital health: