CIMDR Insights On China Medical Device Regulatory Environment
From March 1 to March 4, 2023, the 13th China International Medical Device Regulatory Forum (CIMDR) was held in Fuzhou, Fujian Province, China. CIMDR is one of the most important regulatory conferences in China on medical device, and NMPA, CMDE and related experts attended this forum to release the latest regulatory updates. The major insights from the 13th CIMDR are listed as below.
- NMPA CMDE will reconstruct the review process based on clinical orientation. The review of clinical evaluation reports (CER) based on equivalence for some products with matured review experience will be conducted by CMDE Department 1-6 rather than Clinical and Biostatistics Department 1-2.
- The acceptance of registration projects (excluding class I) indicated a 12.1% year-over-year decrease, while the completion of such projects with 8.9% year-over-year increase from 2021. NMPA CMDE made max effort to increase the review efficiency.
- NMPA continues to encourage the innovation of medica device. In 2022, the NMPA received 343 applications for special approval pathway of innovative medical devices, of which 68 were approved to enter the special review procedure; 55 innovative medical device registrations were approved.
- Comprehensive clinical evaluation system has been established. In China, three clinical pathways of clinical evaluation exemption clinical evaluation based on equivalence and clinical trial are the most powerful basis to support and assist manufacturers to do a good job in clinical evaluation.
- NMPA conducts nine upfront review pilot projects and six Hainan RWS fast track projects approved, among which two approved medical devices with RWE to support clinical evaluation were completed by BradyKnows.
- NMPA promotes the guidelines corresponding to review key points. By 2022, NMPA published 529 guidelines, including 211 for class III, covering 86.9% of China medical device catalogue.
- NMPA pushes forward the self-inspection, MAH system and standard compliance.
- China has become the world’s second largest market for medical devices, showing a big opportunity for overseas medical device manufacturers.
- China mandatory standards are reduced. By optimizing the evaluation, mandatory standards were reduced by 277 items till Sep 2022.
- By 2022, the top 5 fields for manufacturers to apply the classification definition include in vitro diagnostic reagents and equipment; infusion, care and protection equipment; physical therapy equipment; medical software; and active surgical instruments, reflecting the active innovation of such fields.
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