China's National Medical Products Administration (NMPA) has revised its Good Manufacturing Practice for Medical Devices. The new version applies from 1 November 2026 and replaces the GMP that had been in place since 2014. For manufacturers active in the Chinese market, it is the most significant update to China's quality management requirements in more than a decade.
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NMPA just issued GMP Inspection Guideline on 14th Sep 2026 to support GMP implementation on 1 Nov 2026, the guideline includes detailed items and acceptance criteria for GMP inspection.
At a glance
● Issued by: National Medical Products Administration (NMPA), Announcement No. 107 of 2025, published 4 November 2025
● In force: 1 November 2026, replacing the 2014 GMP (CFDA Announcement No. 64 of 2014)
● Structure: 15 chapters, 132 articles
● New chapters: quality assurance; validation and verification; contract manufacture and outsourcing
Why the GMP Was Revised
According to the NMPA, the revision implements the State Council's 2024 opinions on deepening the reform of drug and medical device regulation ([2024] No. 53). Its stated aim is to strengthen quality management systems across the medical device industry and raise overall quality management capability. The NMPA explains that the new GMP integrates current concepts of lifecycle risk management as well as recent domestic and international developments in quality management system requirements, while also addressing regulatory needs arising from digitalisation.
What Changes: Five Key Areas
Alongside the three new chapters, the NMPA notes that other chapters and articles have also been amended. The regulator highlights five characteristics of the revised GMP:
| Focus area | What the NMPA highlights |
|---|---|
| Quality risk management | Risk management applied consistently from R&D and design through to after-sales service, including quality risk management concept and period quality risk reivew. |
| Quality assurance | A stronger quality assurance system within the QMS to keep large-scale manufacturing stable |
| Contract manufacture | Clearer responsibilities at each stage when manufacturing or processes are outsourced |
| Validation and verification | Greater emphasis on validation and verification as a key control of manufacturing processes |
| Digitalisation | Encouragement of digital transformation, including electronic records, IT systems and Unique Device Identification (UDI) |
Who Should Take Note
According to Article 2 of the revised GMP, medical device registrants, filing entities and contract manufacturers must comply with the GMP in all activities related to medical devices, including design, development, manufacture, quality control, product release, sales and after-sales services.
This means the GMP applies to all manufacturers selling medical devices on the Chinese market, including overseas manufacturers and their contract manufacturers, whether they are planning to register devices in China or already have devices on the market. Even if the NMPA does not conduct a pre-market GMP inspection of an overseas manufacturer, the manufacturer is still expected to know and comply with the GMP. For organisations planning China medical device registration, this is particularly relevant, as quality management system documentation forms part of the registration dossier.
How This Relates to ISO 13485
Organisations whose quality management system is certified to ISO 13485 will recognise many of the themes in the revised GMP, such as risk-based thinking across the product lifecycle, verification and validation, and the control of outsourced processes. ISO 13485 certification does not, however, replace compliance with the Chinese GMP: the NMPA’s requirements must be reviewed in their own right and against the full text of the new regulation.
Stay Informed
The revised GMP is one of several developments shaping market access for medical devices in China. In the DQS Academy training “Registration of Medical Devices in China – Fundamentals and Key Requirements” on 3 February 2027 (online, 09:00–13:00 CET), participants gain a structured overview of the Chinese registration framework, the roles of NMPA and CMDE, and current regulatory changes. Further background is available in our Knowledge Center article “China Medical Device Registration: NMPA vs. CMDE Explained”.