Category: Standards

The NMPA published 45 standards on September 7, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. It includes 6 mandatory standards and 39 recommended

The NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601. The standards have been effective since May 1, 2023. For active product manufacturers with existing

The NMPA published 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Standards Industry mandatory standards are