China's Revised Medical Device GMP Takes Effect on 1 November 2026

China's revised Good Manufacturing Practice (GMP) for medical devices takes effect on 1 November 2026. The National Medical Products Administration (NMPA) issued it through Announcement No. 107 of 2025, published on 4 November 2025. The announcement and article 132 of the official GMP attachment repeal the 2014 version under Announcement No. 64 on the same date.

This is preparation for a previously announced replacement, not a newly issued rule. The final instrument does not specify any additional grace period after 1 November. Regulatory and quality teams should distinguish that national effective date from the earlier preparation milestones in their own province.

Scope and the revised structure

Article 2 applies to medical device registrants, record-filers and contract manufacturers during design and development, production, quality control and product release, sales and after-sales service. Article 3 expressly includes commissioned research and development, contract manufacturing, outsourced processing and outsourced testing within the quality management system (QMS).

This article focuses on manufacturing arrangements in China. Article 2 does not set out a separate territorial rule for offshore manufacturing of imported devices, so its role-based wording should not be treated as an express exemption for overseas sites.

The revised GMP contains 15 chapters and 132 articles. NMPA's official interpretation identifies three added chapters: quality assurance, verification and validation, and contract manufacturing and outsourced processing. Adding a chapter does not mean every underlying quality practice is new.

• Quality assurance, chapter 2, articles 7–13: review how the QMS demonstrates product and process control across the product lifecycle.
• Verification and validation, chapter 9, articles 69–77: check plans, protocols, acceptance criteria and retained results. Article 77 requires validation of software that affects product quality in activities including development, manufacturing, testing and warehousing. It covers validation before first use and necessary revalidation after changes, proportionate to risk.
• Contract manufacturing and outsourced processing, chapter 12, articles 107–116: review responsibility allocation, quality agreements, release procedures and control of outsourced activities.

Production release and market release remain separate responsibilities

Articles 104, 108 and 113 define the release and delegation arrangement for contract-manufactured devices:

• Under article 104, the contract manufacturer performs production release; the registrant or record-filer performs market release.
• Under article 108, the delegating party cannot transfer its legally assigned obligations and responsibilities through an agreement.
• Under article 113, the delegating party must carry out market release itself. It reviews manufacturing records, quality-control records and the contractor's production-release documents against its release criteria, with authorized sign-off before market release.

Pure Global's analysis is that a quality agreement and the actual release workflow need to agree: a contractor's production-release approval does not complete the registrant's separate market-release responsibility.

Article 91 also places Unique Device Identification (UDI) coding, data upload and maintenance within the QMS in accordance with the applicable national UDI implementation requirements. It should not be read as a separate expansion of UDI to every device. Article 130 allows product-specific requirements in GMP annexes and requires justification for clauses an enterprise determines are inapplicable to its devices.

Provincial preparation dates

Two published provincial plans provide concrete preparation schedules; they do not change the national effective date:

• Hubei: section III of the implementation plan, dated 30 January 2026, calls for a gap-analysis report and rectification plan by the end of June, and at least one complete internal audit and management review of the new system by the end of October. It states full QMS conformity from 1 November 2026.
• Hunan: section III of the implementation plan, dated 27 January 2026, sets self-inspection and a rectification plan by the end of April, with completed rectification, a report and an upload to the provincial production-registration supervision system by the end of October.

These plans schedule guidance, checks and rectification before implementation. They do not establish that the revised national GMP is already generally in force.

Inspection guidance is a separate instrument

NMPA's 9 June 2026 consultation sought comments on draft GMP Inspection Guiding Principles by 24 June. Our source review on 5 September 2026 did not locate a final successor. The consultation document remains draft evidence for this article and does not postpone the final GMP's effective date.

What to complete before November

Pure Global recommends a clause-by-clause gap review with particular attention to the three added chapters, risk-based software validation, applicable UDI controls and the two release procedures. Check that quality agreements and delegated activities preserve the registrant's own responsibilities. Where a provincial preparation milestone has passed, establish whether the required review, rectification and reporting were completed, and address any outstanding work against that plan.

For related market-access requirements, see our China medical device registration page.