On November 4, the National Medical Products Administration (NMPA) released the revised version of the Good Manufacturing Practice for Medical Devices (hereinafter referred to as the GMP). The new GMP for medical devices shall come into effect as of November 1, 2026.

The new GMP is revised on the basis of the previous version released in 2014. It is an important measure by the NMPA to implement the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote the High-Quality Development of the Pharmaceutical Industry ([2024] No. 53)" and relevant laws and regulations, comprehensively strengthen the quality management system construction of medical device enterprises, and promote the overall improvement of quality management capacity in China's medical device industry.

The new GMP systematically integrates the latest concepts of risk management throughout the whole life cycle of medical devices and new requirements for quality management system construction both domestically and internationally in recent years. While meeting the new demands for innovation and high-quality development of the industry, it also incorporates new regulatory requirements in the digital intelligence era. The aim is to comprehensively promote high-quality industrial development through the institutionalization and legalization of new regulation rules, making it an upgraded version of the GMP that promotes comprehensive progress in enterprises' QMS in the new era.

The revised GMP consists of 15 chapters and 132 articles, adding three new chapters on quality assurance, validation and verification, and contract manufacture and outsourcing. Other chapters and articles have also been amended more or less. The new GMP has the following characteristics: First, it further strengthens the concept of quality risk management, ensuring that risk management runs consistently from R&D design to after-sales service. Second, it further strengthens the construction of the quality assurance system within the quality management system, ensuring the continuous stability of large-scale manufacturing processes. Third, it further strengthens management requirements for new business models such as contract manufacture, clarifying responsibilities at each stage to ensure high-level safety across the entire chain. Fourth, it further emphasizes the importance of the key link of "validation and verification" in operation specification and improving output reliability, ensuring effective control of key elements in the product manufacturing process. Fifth, it further encourages the digital-intelligent transformation in manufacturing, ensuring the effective application of artificial intelligence, information technology, and the Unique Device Identification system.

The implementation of the new GMP will further lay a solid institutional foundation for ensuring the safety and effectiveness of medical devices for the Chinese public and promoting the normative and orderly development of the medical device industry.