On November 4, the National Medical Products Administration (NMPA) released its revised Good Manufacturing Practice (GMP) for medical devices, which will come into effect on November 1, 2026. This is the first major revision of the GMP since 2014, and forms part of the general governmental measures to improve the regulation of medical devices and encourage high-quality development.
The revised GMP introduces a comprehensive approach to establishing quality management systems (QMS) for the medical device industry. It includes the entire life cycle of medical devices, from research and development to marketing authorization and post-marketing surveillance. The new framework is in line with the evolving current domestic and international GMP standards.
The revised GMP is composed of 15 chapters and 132 articles. There are three new chapters — (1) the quality assurance department, (2) validation and verification, and (3) contract manufacturing and outsourcing. These new additions emphasize the importance of a positive internal system of quality assurance; the need for the stabilization of large-scale production processes; and clearly defined responsibilities of all parties involved in outsourcing.
Additionally, the revised GMP encourages the digital transformation of manufacturing. The integration of artificial intelligence, information technology, and the Unique Device Identification (UDI) system to achieve better oversight and traceability.
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.