The China National Medical Products Administration (“NMPA”) issued the newly revised Medical Device Good Manufacturing Practice (hereinafter referred to as the “2025 GMP”) on November 4, 2025. This is the first full revision of the Medical Device GMP since the second revision in 2014. The 2025 GMP revises the main part of the Device GMP and does not affect the appendices, which cover specialized areas, such as dental devices, sterile devices, implantable devices, and software as a medical device. The 2025 GMP takes effect on November 1, 2026, giving medical device companies a grace period of one year to review and update their internal system for compliance with new requirements.
The 2025 GMP is a substantial revision. Among the most significant structural changes, the 2025 GMP now specifically addresses the different roles of medical device registrants (for Class II and III devices), filers (for Class I devices), and the entrusted manufacturing companies (contract manufacturers) engaged by registrants and filers (“R/Fs”). It contains provisions that apply to research and development, production, processing (i.e., entrustment of specific processes), and product testing entrusted to third parties, and requires integration of these functions and entrusted-parties into a unified quality management system that a given device-R/F must oversee as the party chiefly responsible for product quality throughout the device’s lifecycle.
Specifically, the 2025 GMP now contains a separate chapter on “Contract Manufacturing and Outsourced Processing.” This chapter incorporates portions of a prior rule on “Further Strengthening Supervision and Management of Contract Manufacturing by Medical Device Registrants.” It requires the entrusting party (i.e., the R/F) to conduct a full assessment of a contract manufacturer prior to engaging it, perform regular audits of production sites, implement effective control measures, and promptly communicate production changes to contracted parties.
The 2025 GMP incorporates the concept of a “dual release” system from existing rules, which consists of production release by the actual manufacturer and market release by the R/F. R/Fs and manufacturers must manage entrusted processing according to supplier management requirements. The requirements for supplier management have been incorporated from existing supplier guidelines into the significantly expanded chapter on Procurement and Material Management.
The 2025 GMP also incorporates product lifecycle management concepts into a new “Quality Assurance” chapter. This chapter requires companies to have sufficient staff with requisite educational and professional credentials and documentary procedures for change control and risk assessment management throughout the product lifecycle. Additional credential requirements for personnel in mandated positions have been added from existing rules.
The 2025 GMP encourages companies to use digital and “intelligent” measures in production, particularly in the areas of data traceability and tamper-proofing. It adds requirements on the use of digital systems, including on user permissions, tracking modifications to operations, and traceability of records.
Full text of the 2025 GMP is available through this link: https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20251104173724174.html.
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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:
John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.