Category: 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

The NMPA issued the final document of “2023 Medical Device Industry Standards Revisions Plan” on May 24, two weeks after the release of draft version. 15 mandatory and 102 recommended

The NMPA issued the draft version of “2023 Medical Device Industry Standards Revisions Plan” on May 12, 2023, with the deadline for feedbacks on May 19. The plan proposes 15

The NMPA published 20 industry standards on March 17, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. NMPA Industry Standards – Mandatory NMPA Industry

The NMPA published thirty-two industry standards on January 16, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. NMPA Industry Standards January 2023 Mandatory Standards

There have been 108 standards issued by the NMPA in 2022. The revised or newly established standards are aimed to facilitate manufacturers with local type testing, pre-clinical, clinical trial, and