New Medical Device GMP Takes Effect: Five National Standards Also Implemented From November 1

Starting November 1, 2026, China’s revised Good Manufacturing Practice for Medical Devices (Medical Device GMP) and the supporting Inspection Guidelines for the Good Manufacturing Practice for Medical Devices officially take effect.

At the same time, five national standards covering cleanroom testing, micro-vibration control and precision analytical instruments also come into effect.

For medical device companies, the main changes center on upgrades to production quality management systems, as well as adjustments to inspections for manufacturing licenses and post-market supervision.

Revised Medical Device GMP Strengthens Contract Manufacturing and Quality Management

The revised Medical Device GMP was issued by China’s National Medical Products Administration (NMPA) in November 2025. It contains 15 chapters and 132 articles, adding three new chapters on quality assurance, qualification and validation, and contract manufacturing and outsourced processing to the previous framework.

The revision mainly covers the following areas:

• Lifecycle risk management: Risk management is further integrated throughout product design and development, manufacturing and post-market services.

• Contract manufacturing: The revised GMP strengthens the quality management responsibilities of medical device registrants, filing entities and contracted manufacturers.

• Qualification and validation: Requirements for the qualification and validation of critical manufacturing processes, equipment and procedures are strengthened.

• Digital quality management: The revised GMP emphasizes the application of information technologies, artificial intelligence and Unique Device Identification (UDI) in quality management.

For innovative medical device companies using contract manufacturing models, as well as manufacturers of implantable, sterile and other devices involving complex production processes, the revised requirements make it necessary to further review whether their quality management systems, supplier management, production validation and related records meet the new requirements.

Official source: NMPA, Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025).

New Inspection Guidelines Take Effect, Adjusting Both Licensing Inspections and Post-Market Supervision

In September 2026, the NMPA issued the Inspection Guidelines for the Good Manufacturing Practice for Medical Devices, which also take effect on November 1.

Under the implementation arrangements:

Manufacturing licenses: From November 1, inspections for new medical device manufacturing licenses, license changes and renewals will be conducted in accordance with the revised GMP. Certain applications that were accepted before November 1 but for which licensing decisions have not yet been completed will also be inspected under the revised requirements.

Post-market inspections: Provincial medical products administrations will formulate inspection plans based on the risk levels of products and manufacturers, and will conduct phased inspections to achieve full coverage of compliance with the revised GMP.

Class I medical devices: After a company completes a manufacturing filing for Class I medical devices, the regulatory authority should conduct an on-site inspection of the submitted materials and GMP implementation within three months.

In addition, manufacturers of sterile medical devices, implantable medical devices, in vitro diagnostic reagents, custom-made dentures and standalone medical software must also comply with the applicable existing GMP appendices.

The revised GMP therefore applies not only to companies applying for new manufacturing licenses. Its implementation will gradually cover medical device manufacturers that already hold manufacturing licenses and are currently engaged in production and business operations.

Official source: NMPA, Inspection Guidelines for the Good Manufacturing Practice for Medical Devices (NMPA Medical Device Supervision [2026] No. 14).

Five National Standards Take Effect, Covering Cleanrooms and Testing Equipment

From November 1, the following five recommended national standards also take effect:

The first three standards directly address the testing of airborne particles and microorganisms in clean environments. They may serve as references for testing organizations, cleanroom engineering companies and medical device manufacturers operating controlled production environments.

The other two standards cover Fourier transform infrared spectrometers and micro-vibration control in cleanrooms and related controlled environments.

It should be noted that all five are recommended national standards (GB/T) rather than mandatory national standards. Their publication does not automatically make them compulsory for every medical device manufacturer.

Companies should determine whether and how the standards apply based on their manufacturing processes, product requirements and applicable regulatory obligations.

Official source: China’s National Public Service Platform for Standards Information.

For medical device manufacturers, the priority before implementation of the new requirements is to review gaps between their existing quality management systems and the revised GMP, identify manufacturing licensing matters currently in process, and prepare for requirements related to contract manufacturing, validation of critical processes and post-market regulatory inspections. October 30, 2026