NMPA CMDE Annual Report For Year 2022
The Center For Medical Device Evaluation of NMPA (NMPA CMDE for short) has made a summary of the work in 2022, the report is as follows:
Ⅰ. Registration application
It accepted 20,865 applications for registration of medical devices, including 5,389 filing changes, 2,035 imported Class I filing. A total of 13,066 applications were transferred to the technical review process, the transfer of the finalized project 14,486, 1,300 more than in 2021, an increase of 9.9 percent year-on-year.
II. Emergency Review Status
- 11 Nucleic acid test kit
- 10 Antibody test kit
- 47 Antigen detection kits
- 2 Medical device products
III. Review time
| Application Type | Product Category | Average review time | Average time for expert consultation | Average time for applicant supplementary phase | Total time |
| Product Registration | Class II | 72 | 0 | 245 | 317 |
| Class III | 99 | 1 | 178 | 278 | |
| Class II + Class III | 95 | 1 | 187 | 283 | |
| Registration change of permitted matters | Class II | 45 | 0 | 81 | 126 |
| Class III | 69 | 0 | 60 | 129 | |
| Class II + Class III | 64 | 0 | 64 | 128 | |
| Renewal Registration | Class II | 24 | 0 | 13 | 37 |
| Class III | 46 | 0 | 28 | 74 | |
| Class II + Class III | 39 | 0 | 24 | 62 |
IV. Collective decision-making
- 29 meetings of CMDE technical meetings
- 679 meetings of CMDE branch technical meetings
Ⅴ. Deficiency letter, expert panel meeting and audit
- Supplementary Information for deficiency letter
Issued 5,698 deficiency letters
Received 5,626 items of supplementary dossiers - Expert panel meeting
Initiated 114 expert panel meetings
Organized 107 expert panel meetings - QMS audit
Initiated 2,465 QMS audits
Received 2,125 auditing results
Ⅵ. Innovation and priority review
Special review of innovative medical devices
- Received 343 innovation applications, up 37.8% year-on-year;
- Organized and held 309 expert review meetings;
- Completed review of 361 items.
Priority approval for medical device audits
- Received 31 priority approval requests, down 24.4% year-on-year;
- Organized 13 expert review meetings;
- Completed the review of 34 items.
Ⅶ. Manufacturer consulting
- Provided 7,717 times ofpre-acceptance consultation
- Provided 6,466 times of supplementary dossier consultation
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