China GMP Revision (Announcement No. 107 of 2025): Preparing for the 2026 Conversion

1. Key takeaways

The Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025) was published on 4 November 2025 and takes effect on 1 November 2026; it runs to 15 chapters and 132 articles and repeals Announcement No. 64 of 2014.

• The revision adds three chapters — quality assurance, verification and validation, entrusted production and outsourcing — each answering a category of recurring system weakness.
• Publication to commencement spans about 12 months (4 November 2025 to 1 November 2026), the window left for rewriting the system and its documents (practical estimate).
• The revision reaches beyond production: registration quality system inspection (Articles 47 to 49, plus the 2022 guideline) also takes the practice as its reference, so registration timelines move with it.
• On-site inspection for a production licence may be combined with the registration system inspection (Article 13 of the Production Measures), so a late document conversion slows both tracks at once.
• Entrusted production and outsourcing now form a separate chapter, imposing finer documentary requirements on responsibility allocation under Article 34.

2. Legal basis

Administrative regulation. Medical Device Supervision and Administration Regulation (State Council Order No. 739), promulgated 9 February 2021, effective 1 June 2021.

• Article 13: Class I filed, Class II and III registered, with lifecycle liability. Article 20, paragraph 1: five duties, the first concerning the quality system.
• Article 32: Class II and III production requires a licence, decided within 20 working days of acceptance; the licence runs five years.
• Article 34: in-house or entrusted manufacture, and the principle for allocating responsibility between holder and trustee.

Departmental rules. Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47), promulgated 26 August 2021, effective 1 October 2021: Article 15: quality system; Articles 47 to 49: organisation and focus of registration system inspection.

Measures for the Supervision and Administration of Medical Device Production (SAMR Order No. 53), promulgated 10 March 2022, effective 1 May 2022.

• Article 4: classified production, Class II and III under licence, Class I under filing; Article 10: application materials.
• Article 13: decision within 20 working days, certificate within 10 working days of approval, on-site inspection combinable with the registration system inspection; Article 14: valid five years.
• Article 17: renewal between 90 and 30 working days before expiry; Article 22: Class I filing with inspection within three months.
• Article 25: production quality requirements (wording outside the verification scope here; the text in force governs).

Normative documents. Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025), 4 November 2025, effective 1 November 2026: 15 chapters, 132 articles, adding quality assurance, verification and validation, entrusted production and outsourcing; repeals Announcement No. 64 of 2014. Registration QMS Inspection Guideline (Notice No. 50 of 2022), 29 September 2022, effective on issue, repealing Notice No. 19 of 2020.

Practical estimate. The article-level content of Announcement No. 107, chapter titles, transitional arrangements and the interface with earlier documents are not held here as verified text. The chapter description is limited to the structural information published; implementation must follow the full text from NMPA. No official deadline for completing the conversion is held here; it must be confirmed with the provincial administration.

3. Expert insights

Three new chapters, three long-standing weaknesses. The additions are not random length: each maps onto a defect that recurs in inspection and system audit.

The first carries the most weight: many systems behave like a testing system, where the department tests and releases but never judges whether the system works. A separate assurance chapter requires a function evaluating system effectiveness, not only batch conformity.

From 2014 to 2025, inspection moves from conformity to effectiveness. Since 2014 the habit has been one document per clause, producing complete files around an idle system.

The scale of 15 chapters and 132 articles says the same: patching documents is now expensive, so each requirement must become an observable action with corroborating evidence.

The conversion window overlaps licensing and renewal. Three timelines must be read together.

The high-risk case is a licence expiring in late 2026, with renewal due between 90 and 30 working days before expiry (Article 17) and the conversion unfinished. Which version the inspection follows must be confirmed with the provincial administration at scheduling (practical estimate).

Registration system inspection and licence inspection share one evidence set. Article 13 allows that combination, and Articles 47 to 49 with the 2022 guideline set the organisation and focus, so the revision affects more than licensed holders.

Class I manufacturers underestimate it: Article 22 requires inspection within three months of the production filing, and Class I sits inside the scope as well.

A separate chapter on entrusted production changes the boundary of the holder’s system documents. Article 34 allows entrusting a qualified manufacturer, the holder bearing primary responsibility; the new chapter turns that principle into documents.

The fourth column is where practice is thinnest: each side holds its documents while the interface is one principle-level quality agreement. The new chapter requires that interface to be documented and procedural, so a holder cannot rely on the trustee having a system.

4. Practical recommendations

• Schedule the conversion backwards from 1 November 2026, placing rewriting, training, trial running and internal audit in the plan.
• Build an independent quality assurance function, separating system effectiveness review from testing and release, with a stated cycle, method and output report.
• Create one validation master plan covering equipment, process, cleaning and software, with defined drafting, approval and countersign paths.
• Complete the entrusted-production interface documents for change control, validation and release authorisation.
• Build the gap list by article, not by department, in four columns: article, current state, evidence, action. Department lists miss cross-functional flows, which the new chapters address.
• Overlay the licence and renewal timelines, checking the expiry date against the renewal window of 90 to 30 working days before expiry (Article 17).

5. Verification checklist

• □ Full text of Announcement No. 107 obtained; 15 chapters, 132 articles confirmed
• □ Commencement (1 November 2026) and repeal of Announcement No. 64 of 2014 confirmed
• □ Gap analysis complete for the three new chapters
• □ Quality assurance function independent of testing and release
• □ Validation activities under one master plan
• □ Interface documents cover change control, validation, release authorisation
• □ Gap list built in four columns and spanning cross-functional flows
• □ Licence expiry and renewal window (90 to 30 working days) scheduled
• □ First licence inspection prepared to the new version (20 working days)
• □ Version confirmed with the inspection body for products under review
• □ Class I producers self-checked (inspection within three months of filing)
• □ All-staff training completed and recorded

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages adverse event monitoring and recall filings with NMPA, maintains UDI compliance, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com