China Issues Comprehensive Guidelines for Medical Device Registration Self-Inspection
China's National Medical Products Administration (NMPA) has released comprehensive guidelines for medical device registration self-inspection, marking a significant step forward in strengthening the country's medical device regulatory framework.
The new guidance, officially titled "Guidelines for Medical Device Registration Self-Inspection" (NMPA Regulation No. 499, 2025), was published to enhance medical device registration management, standardize self-inspection procedures by registration applicants, and ensure orderly development of medical device registration self-inspection activities.
Comprehensive Quality Management System Required
The guidelines establish stringent requirements for companies conducting self-inspection of medical devices, including in vitro diagnostic reagents. Registration applicants must integrate self-inspection work into their medical device quality management systems and comply with Good Manufacturing Practices (GMP) for medical devices and supporting regulations.
Companies must demonstrate appropriate self-inspection capabilities, which include having inspection equipment and facilities that meet product testing requirements, maintaining dedicated quality inspection departments or full-time inspection personnel, implementing strict inspection process controls, and ensuring test results are authentic, accurate, complete, and traceable.
Personnel and Equipment Standards
The guidelines set forth detailed requirements for inspection personnel, mandating that they be formally employed, full-time staff working exclusively for the company. Personnel must possess educational backgrounds and technical capabilities matching the inspection work, and undergo training in medical device laws, regulations, standards, and technical requirements.
For equipment and environmental facilities, companies must configure equipment meeting inspection method requirements and maintain comprehensive records including equipment files, operating procedures, calibration certificates, and maintenance records. Special attention is given to laboratories conducting specialized testing, such as clean rooms, biological laboratories, electromagnetic compatibility laboratories, and PCR laboratories, all of which must meet specific environmental and technical standards.
Quality Control and Record Management
The new framework emphasizes robust quality control procedures to ensure the validity of inspection results. Companies must establish both internal control methods, including personnel comparison, equipment comparison, and blind sample testing, as well as external control methods such as proficiency testing and inter-laboratory comparisons.
Record-keeping requirements are particularly stringent, with companies required to maintain complete technical records containing sufficient information to identify factors affecting measurement results and measurement uncertainty. These records must enable reproduction of laboratory activities under similar conditions and demonstrate the traceability of all testing processes.
Regulatory Oversight Enhanced
Drug regulatory authorities may conduct on-site inspections of self-inspection capabilities when necessary, focusing on personnel qualifications, equipment adequacy, environmental facilities, sample management procedures, inspection quality control measures, and record control systems related to product self-inspection.
The guidelines allow for documentation review in certain circumstances, particularly when self-inspection laboratories have obtained accreditation from the China National Accreditation Service for Conformity Assessment (CNAS) for relevant testing scopes, which can streamline the regulatory review process.
Industry Impact
The new guidelines apply to Class II and Class III medical devices and serve as both guidance for regulatory authorities conducting self-inspection audits and reference material for registration applicants implementing self-inspection work. However, they do not apply to situations where registration applicants outsource all testing items to qualified medical device testing institutions.
Implementation Timeline
The guidelines took effect immediately upon publication on September 16, 2025, and are expected to significantly impact how medical device companies approach registration testing and quality management in China. Companies will need to reassess their current testing capabilities and may need to invest in additional personnel training, equipment upgrades, and quality system enhancements to meet the new requirements.
This regulatory development reflects China's continued efforts to align its medical device oversight with international best practices while ensuring the safety and efficacy of medical devices entering the Chinese market. The enhanced self-inspection framework is designed to improve product quality control at the manufacturer level while maintaining rigorous regulatory oversight of the approval process.