On 4 November 2025, the National Medical Products Administration (“NMPA”) of the People’s Republic of China (“PRC”) released the revised Good Manufacturing Practice for Medical Devices (“Medical Devices GMP”), which will take effect on 1 November 2026 and replace the 2014 version.
This revised Medical Devices GMP marks the most comprehensive restructuring of China’s Medical Devices GMP framework. Beyond refining existing provisions, the new Medical Devices GMP introduces paradigm-shifting requirements for product quality governance, lifecycle risk management, and supply chain accountability, especially by taking into account the development of medical devices marketing authorization holders (“MAH”) regime.
1. Overview of the Medical Devices GMP
The new Medical Devices GMP represents a structural overhaul aligned with China’s broader regulatory initiatives, including the Regulations on the Supervision and Administration of Medical Devices and State Council’s Comprehensive Deepening Reform of Drug and Medical Devices Supervision to Promote High-Quality Development of the Pharmaceutical Industry (2024). It shows the regulator’s commitment to strengthening the quality management system (“QMS”) of medical devices enterprises and elevating the overall quality management standards of China’s medical devices industry.
The scope of application has been explicitly extended to MAHs, filing applicants, and all entities involved in contract manufacturing, emphasizing full-chain responsibilities. The revised Medical Devices GMP is extended to 15 chapters and 131 articles, introducing three new chapters: (1) Quality Assurance, (2) Verification and Validation, and (3) Contract Manufacturing and Outsourcing. These new provisions and adjustments reflect a strengthened emphasis on critical areas due to the MAH regime, including risk control based full lifecycle quality management concepts, digital and intelligent transformation and contract manufacturing.
This revised Medical Devices GMP will take effect on 1 November 2026, leaving enterprises one year to adapt their current practice to the new requirements.
2. Key Changes of Medical Devices GMP
a) Quality Assurance
The revised Medical Devices GMP introduces a new chapter titled “Quality Assurance”, which primarily incorporates requirements under the Provisions on Supervising the Implementation of Medical Devices Quality and Safety Responsibilities by Enterprises (NMPA No. 124, 2022). Thus, these requirements are not entirely new.
The revised Medical Devices GMP standard stipulates the following key requirements: Enterprises must establish quality objectives that align with medical devices quality management requirements, allocate adequate and compliant resources such as personnel, facilities, and equipment, and establish and maintain a quality assurance system, change control procedures, and a quality risk management system. In addition, medical devices enterprises are required to collect quality risk information throughout the entire product lifecycle to ensure the ongoing effectiveness of risk management measures.
b) Verification and Validation
Another newly introduced chapter is the chapter “Verification and Validation”. The Regulations on the Supervision and Administration of Medical Devices Production provide a general requirement on verification and validation covering from design to final manufacturing. The requirements for this matter in the current Medical Devices GMP are scattered across various chapters. This new chapter now establishes a systematic framework to ensure more rigorous control over all critical aspects of production. Under the revised Medical Devices GMP, medical devices manufacturers are explicitly required to conduct risk control based verification and validation activities, to demonstrate that key elements, including facilities, equipment, operations, and product realization processes, are effectively controlled. This must be thoroughly documented to prove that design, installation, and operational performance conform to intended use and regulatory standards.
Furthermore, the new Medical Devices GMP also requires to carry out re-verification or re-validation when changes occur in critical factors, such as raw materials, processes or production environments, or when quality trend analysis indicates a need. Another new obligation is that medical devices enterprises must also develop structured validation plans, which include confirmation of computerized systems used in development, production and testing. Based on the current requirement, software validation, in particular, must be performed upon initial use and after modifications, with methods aligned to the associated risks.
c) Contract Manufacturing and Outsourcing
The NMPA has been progressively strengthening supervision on contract manufacturing. In 2024, the NMPA issued the Announcement on Further Strengthening the Supervision of Contract Manufacturing by Medical Devices Marketing Authorization Holders (NMPA No. 38, 2024), establishing and refining specific requirements for contract manufacturing. These requirements have now been incorporated into a dedicated chapter of “Contract Manufacturing and Outsourcing”.
This chapter addresses growing regulatory concerns over fragmented supply chains and delegated production activities. It clarifies quality responsibilities across outsourced processes. Key provisions include that MAHs shall retain non-transferable and ultimate quality responsibility, and shall sign formal agreements defining specifications, change control, and audit rights, etc. with the entrusted medical devices manufacturers. Medical devices manufacturers must qualify and periodically reassess suppliers, ensuring their adherence to established quality standards. The rules further emphasize data integrity and traceability across the supply chain, particularly for digitally managed processes.
d) Changes in Other Aspects
(1) Institutional and Personnel Arrangements
The revised Medical Devices GMP explicitly specifies a list of key positions and provides for the qualification requirements and core responsibilities for critical roles, including:
• enterprise’s legal representative,
• primary responsible person,
• management representative,
• head of the production management department,
• head of the quality management department, and
• product release reviewer.
It is worth noting that under the new Medical Devices GMP, all these positions shall be taken by full-time employees, whereas in the current regulations, only the management representative is explicitly required to be a full-time employee. Also, Article 14 further emphasizes that the head of the production management department cannot concurrently take the position of the head of quality management department, which is in line with the requirements under Provisions on Supervising the Implementation of Medical Devices Quality and Safety Responsibilities by Enterprises.
For small and middle size medical devices companies, this new requirement regarding full time employees will probably increase their labor costs. Enterprises need to assess these new requirements to determine whether any new personnel needs to be recruited.
(2) Facility and Equipment Management
The revisions to the “Plant and Facilities” and “Equipment” chapters focus on clarity and comprehensive control rather than introducing entirely new concepts. A pivotal change is the first-time inclusion of mandatory, universal requirements for computerized system management and strict access control to production areas. A detailed new requirement should also be noted, i.e., enterprises must regularly calibrate or verify major equipment and instruments according to standard operating procedures and a defined calibration or verification plan, and the calibrated range must cover the actual range of use.
(3) Document and Data Control
An important change is the introduction of mandatory, universal requirements for electronic record management. This new change explicitly requires user access control, audit trails for changes, and data backup. Another new provision requires companies to proactively monitor and implement new external regulations.
(4) Design and Development Control
The chapter of “Design and Development” introduces many enhancements compared to the current version and several entirely new requirements have been established. These new rules provide for a systematic “design and development file” for complete traceability. The revised Medical Devices GMP standard also provides for a new detailed rule for controlling outsourced design. Furthermore, the use of risk management methods and tools throughout the entire process is now explicitly required.
(5) Procurement and Raw Material Management
The revised chapter on “Procurement and Raw Material Control” stipulates some requirements already set forth under 2015 Guidelines for Supplier Audits of Medical Devices Manufacturers. Key enhancements include the classified management of suppliers, supplier audit system and regular review. The revisions also focus on new obligations, such as the quality archives, warehousing management and records, “first-in, first-out” rule, etc.
(6) Production Management
The revised Medical Devices GMP strengthens production control through several key new requirements. The most significant changes include the material balance as a mandatory verification step to detect production anomalies, and the formal requirement for a comprehensive “deviation handling procedure” covering the entire production and testing process. Furthermore, the chapter explicitly addresses complex production scenarios for the first time, mandating risk-based controls for shared production facilities/equipment, continuous production (with validated maximum batch counts/duration), and production resumption after stoppages.
(7) Quality Control and Product Release
This revised chapter elevates quality control standards by introducing several mandatory new procedures. Key changes include explicit requirements for personnel competency verification, formal management of testing samples and reagents, controlled laboratory environments, and documented investigations for all out-of-specification results. It also integrates detailed product release criteria and requirements as set out in the 2016 Guidelines for Quality Control and Finished Product Release by Medical Devices Manufacturers.
3. Conclusion
The revised Medical Devices GMP represents a significant update to China’s medical devices regulatory regime, shifting toward a more comprehensive, risk control based, lifecycle-oriented GMP framework. The inclusion of three additional core chapters, i.e., Quality Assurance, Verification and Validation, and Contract Manufacturing and Outsourcing, reflects the NMPA’s intention to reinforce full lifecycle risk management, enhance supply chain oversight, and strengthen data reliability through digital and intelligent systems.
The revised Medical Devices GMP applies to domestic and overseas MAHs, filing applicants, and contracted manufacturers. For domestic and overseas MAHs, they must ensure that their entrusted manufacturers, QMS, and digital infrastructures conform to the updated requirements.
Failing to comply with the revised Medical Devices GMP may face the legal risks under PRC medical devices regulations. For instance, if such violation impairs product safety and effectiveness, penalties include confiscation of non-compliant devices and fines up to 30 times of the total value of the medical devices sold. For serious cases, additional sanctions may involve suspension or revocation of licenses, along with confiscation of income and fines up to 3 times of the income earned by responsible personnel, who may also face a 10-year industry ban.
It is advisable that enterprises should begin preparing as earlier as possible by conducting gap analyses, restructuring documentation, upgrading computerized systems, and reassessing outsourcing and supplier arrangements.
