China's revised medical device GMP takes effect 1 November 2026:
what changes for contract manufacturing

On 4 November 2025 the NMPA published a revised Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025). It takes effect 1 November 2026 — replacing the 2014 version that has governed device manufacturing quality systems in China for over a decade.

If you are an overseas registrant having a device manufactured in China, or a domestic registrant using a contract manufacturer, one part of this revision concerns you directly: a dedicated chapter on contract manufacturing and external processing now exists where previously there was none.

The announcement sets out five points of emphasis: strengthening quality risk management; strengthening the quality assurance system within the quality management system; strengthening the management of new business models such as contract manufacturing, and clarifying responsibility at each stage; strengthening verification and validation as a critical control point; and encouraging digital and intelligent transformation of manufacturing.

The third point is the one to read twice. Under the registrant system, a registrant holds the certificate and a contract manufacturer holds the manufacturing licence — but the allocation of responsibility between them has been governed largely by contract and by general provisions. A dedicated chapter changes that baseline.

We are not going to pretend we can tell you the full compliance impact from the chapter headings alone; the detailed articles need to be read against your specific product and arrangement, and implementation guidance may follow. What we can say is which questions become worth asking now rather than in October 2026:

• Does your existing quality agreement allocate responsibility article by article, or in general terms? A regulation that clarifies responsibility per stage tends to expose agreements that do not.
• Who performs, and who reviews, verification and validation? With verification and validation elevated to its own chapter, the division of work between registrant and manufacturer on IQ/OQ/PQ and test-method validation deserves to be written down explicitly.
• How is change control handled across the two organisations? If your manufacturer changes a process, material or supplier, what triggers a notification to you, and what triggers your approval?
• Does your manufacturer have external processing (外协加工) in the chain, and do you know about it? External processing is now named alongside contract manufacturing. If part of your product is processed by a fourth party, that should be visible to you.
• What is your manufacturer's transition plan? Existing quality systems built to the 2014 version will need to be reviewed against 15 chapters rather than 10. Ask for the plan, not the assurance.

The platform operates under ISO 13485:2016 and ISO 9001:2015 (certified December 2023), and its first contract manufacturing project passed the drug administration's registration quality system inspection with zero findings in March 2023. We are reviewing our quality system against the revised regulation ahead of the effective date, and we are willing to walk a prospective registrant through that review — including the parts that are still open.

Source: NMPA, "Announcement on the Publication of the Good Manufacturing Practice for Medical Devices" (Announcement No. 107 of 2025), published 4 November 2025, effective 1 November 2026. This page summarises the published announcement — chapter structure, article count and the stated points of emphasis. It is not a clause-by-clause analysis and it is not regulatory advice. Verify against the official text, and against implementation guidance as it is issued.