5 docs tagged with "digital-health"

NMPA AI/ML algorithm change protocol guidance and requirements for AI-enabled medical devices in China.

NMPA cybersecurity requirements for networked and connected medical devices in China.

Overview of China's regulatory framework for digital health products and SaMD under NMPA.

How NMPA classifies standalone software as medical devices under the 2021 classification rules.

IEC 62304 application in China and NMPA software lifecycle documentation expectations.