NMPA published the revised Good Manufacturing Practice for Medical Devices as Announcement No. 107 of 2025 on 4 November 2025. It takes effect on 1 November 2026 and replaces the 2014 rules (Announcement No. 64 of 2014).

This is the largest revision since 2014: the structure grows from 10 chapters to 15, and from roughly 80 articles to 132.

First, contract manufacturing becomes its own chapter (Chapter 12, Articles 107–116). The contract giver’s quality system must cover the full product life cycle, both parties must sign a quality agreement, and the contract giver may not use that agreement to transfer obligations the law places on it.

Second, "dual release" (Article 113). The contract giver must establish a market-release procedure and review the production records, quality-control records and the contract acceptor’s release documents item by item; release is signed off by authorised personnel and must be performed by the contract giver itself.

Third, qualification requirements for the management representative (Article 19). For Class II and Class III manufacturers the representative needs a bachelor’s degree in a device-related field or an intermediate professional title, and in principle three years of relevant experience.

Quality assurance is also promoted to a standalone Chapter 2 (Articles 7–13), and a new clause encourages digital and intelligent transformation.

Who in this database it affects

In this database 21,908 Chinese companies hold Class II or Class III registrations — the new GMP requirements on management-representative qualifications and dual release land squarely on this group. Full list: Chinese companies.

How our data is verified

Every market figure on this site is the result of **re-checking each manufacturer name record by record**, not a raw hit count from a registry search interface. Name search in these registries is generally a substring match: searching EUDAMED for "Edan" returns 1,933 records, of which 434 belong to HANEDAN in Turkey and 300 to TeDan Surgical in the United States — taking the raw count would overstate by more than 60 percent. We therefore require the distinctive token to appear as a whole word and demand a genuinely distinguishing shared token; generic words such as "medical" or "systems" never qualify on their own, and the similar names that were excluded are listed on each company page. Each market counts a different unit (the EU counts UDI-DI device records, the US counts listed device types, Canada and Brazil count valid registrations, Korea counts quality-system certifications), so figures cannot be summed or compared across markets. The full basis, official portals and query paths are at the methodology page.

Related

Related: The 14 registries side by side　·　Chinese companies　·　Methodology and query paths　·　Data sources and licences.

NMPA Announcement No. 107 of 2025 (published 4 November 2025)