Category: Standards

NMPA issued the “2025 Medical Device Industry Standards Revisions Plan” on February 24, 2025. Six mandatory and seventy-nine recommended standards will be revised or established. The Standards Revisions are aimed

The NMPA released 49 national standards and 90 industry standards for medical devices and in vitro diagnostics (IVDs) in 2024. These standards were revised or newly established to assist manufacturers

Thirty-four newly established or revised industry standards were released by NMPA on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Compliance

Thirty-four newly established or revised industry standards were released by NMPA on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Compliance

Thirty-six newly established or revised industry standards were released by NMPA on July 10, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Compliance

NMPA issued the “List of Mandatory Standards Applicable to Medical Devices” on June 13, 2024, directing manufacturers for type testing and regulatory submission. Over 400 mandatory national and industry standards

NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March 29. The plan proposes 8 mandatory

Twenty newly-established or revised industry standards were released by NMPA on February 19, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Full List Industry mandatory

Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Mandatory Standards Recommended 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