Summary

China’s National Medical Products Administration (NMPA) has issued a revised Good Manufacturing Practice for Medical Devices under Announcement No. 107. The new requirements replace the previous GMP framework issued in 2014 and apply to medical device registrants, filing holders and contract manufacturers.

The revised GMP consists of 15 chapters and 132 articles. It strengthens quality assurance and lifecycle risk management, with dedicated chapters covering quality assurance, validation and verification, as well as contract manufacturing and outsourcing.

The requirements cover the full product lifecycle, including design and development, manufacturing, quality control, product release, sales and after-sales service. They also establish more detailed expectations for quality management responsibilities, personnel, documentation and electronic records, validation of processes and computer software, and the management of outsourced activities.

The regulation reinforces the responsibilities of registrants and filing holders in contract manufacturing arrangements. These include supplier and contractor assessment, quality agreements, oversight of outsourced operations and responsibility for the final marketing release of products.

The document is relevant to medical device manufacturers, registrants, filing holders, contract manufacturers, quality assurance and regulatory affairs professionals, and international companies operating in or supplying the Chinese medical device market.

Publisher: National Medical Products Administration (NMPA), China

Document type: Good Manufacturing Practice (GMP) requirements for medical device manufacturing

Publication date: 4 November 2025

Status: Published — effective from 1 November 2026

Official source: Official Chinese source

English-language announcement: NMPA announcement