On November 4, the NMPA released the revised “Medical Device Manufacturing Quality Management Specifications” (GMP for medical device in China). The new version will take effect on November 1, 2026, and the previous version issued in 2014 (No. 64) will be repealed at the same time.
The revised GMP consists of 15 chapters and 132 articles. Three new chapters have been added: Quality Assurance, Validation and Verification, and Contract Manufacturing and External Processing. In addition, other chapters have been modified to varying degrees.
The new version introduces several key enhancements:
- Reinforces the concept of quality risk management throughout the entire product lifecycle—from R&D and design to after-sales service.
- Emphasizes the establishment of a robust quality assurance system to ensure stability in large-scale manufacturing.
- Strengthens requirements for managing new business models such as contract manufacturing, with clear responsibilities defined to guarantee safety across the entire supply chain.
- Highlights the critical role of validation and verification in ensuring process reliability and controlling key production parameters.
- Encourages digital transformation in manufacturing, ensuring effective application of artificial intelligence, information technology, and Unique Device Identification (UDI).
Manufacturers should start preparing now to ensure full compliance with the new GMP by November 1, 2026.
