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
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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