China’s National Medical Products Administration (NMPA) has released updated Good Manufacturing Practice (GMP) rules. The new rules introduce a revised quality management system (QMS) framework and will take effect on November 1, 2026. The regulation applies to both domestic and foreign manufacturers supplying devices in China.
The new GMP reclassifies existing criteria and introduces new sections. It places greater emphasis on managing quality across the entire product lifecycle – design, development, production, and post-market activities. Additionally, there is now a greater focus on risk management and quality assurance processes.
The new GMP also provides a more rigorous expectation for validation, verification, and supplier oversight. The new GMP addresses new technology trends, such as the use of AI and other technologies in manufacturing. Requirements for personnel qualifications and responsibilities are more clearly defined. For example, if key staff members do not meet requirements in terms of education and previous work experience, the company will not be in compliance with the updated GMP standards.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.