MEDTECH NEWS
China Issues Comprehensive Guidelines for Medical Device Registration Self-Inspection
29 09 2025China's National Medical Products Administration (NMPA) has issued new comprehensive guidelines for medical device registration self-inspection, effective September 16, 2025. The regulations require companies to integrate self-inspection capabilities into their quality management systems, maintain qualified full-time personnel, and ensure proper equipment and facilities for testing Class II and III medical devices. Key requirements include stringent quality control procedures, comprehensive record-keeping, and compliance with Good Manufacturing Practices. Regulatory authorities will conduct oversight inspections focusing on personnel qualifications, equipment adequacy, and quality control measures. The guidelines aim to strengthen China's medical device regulatory framework while aligning with international best practices, though they do not apply to companies that outsource all testing to qualified institutions. This regulatory enhancement is expected to significantly impact how medical device manufacturers approach registration testing and quality management in the Chinese market.