China NMPA New Approvals in March 2024
In March 2024, China NMPA approved 325 medical devices, including 29 Class III imported products, 30 Class II imported products, and 265 Class III domestic products. China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. GVM Medical LLC has extensive experience to support …
Guidelines for registration review of alginate dressings（Draft）
On April 28, China NMPA.CMDE issued the draft guidance “Guidelines for registration review of alginate dressings”. CMDE call for public comments on the draft guidance before 5th June.
[China NMPA.CMDE]Review time of submissions for registration completed and transferred in March 2024
Submission type Product classification Average review time(days) Average time of expert consultation(days) Average time of deficiency response(days) Total time(days) Product registration Class II 72 0 293 365 Class III 99 1 164 265 Class II and III 96 1 180 278 Change of registration Class II 51 0 69 120 Class III 72 0 73 …
Summary of medical device technical review in February 2024
The following is the summary of China CMDE medical device technical review in February 2024: Submissions Overview In Process of Technical Review:1067 Technical Review Completed:1038 Submissions Accepted Document Review:1255 Submissions Accepted:1573 Filing Modification :549 Import Class I Device Filing:107 RFEs and Responses to RFEs RFE released: 497 RFE Response Accepted: 477 Advisory Meetings Meeting initiated: …
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Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)
On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”. CMDE called for public comments on the draft guidelines before May 6th.
Guidelines for Registration Review of Laparoscopic Surgery Systems Part 5: Systems and Software
On April 22nd ,2024, China CMDE has started the preparation of “Guidelines for Registration Review of Laparoscopic Surgery Systems Part 5: Systems and Software”. Based on the published “Key Points for Technical Review of Laparoscopic Surgery Systems (2023 Revised Edition)”, refine and improve the relevant requirements for the system and software parts (excluding end effectors) …
China CMDE FAQ
Question：Is it acceptable to make cross reference to the research documents of the transcatheter mitral valve clamp if the transcatheter tricuspid valve clamp is from the same company and with the same design, materials and manufacturing process as those of the transcatheter mitral valve clamp? Answer：You can do so after demonstrating their subsequent equivalence. The …
Summary of medical device technical review in March 2024
The following is the summary of medical device technical review in March 2024: Submissions Overview In Process of Technical Review:1371 Technical Review Completed:1254 Submissions Accepted Document Review:1423 Submissions Accepted:2140 Filing Modification :801 Import Class I Device Filing:242 RFEs and Responses to RFEs RFE released: 607 RFE Response Accepted: 639 Advisory Meetings Meeting initiated: 12 Meeting …
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