CMDE

Summary of medical device technical review in April 2024

The following is the summary of medical device technical review in April 2024: Submissions Overview In Process of Technical Review:1500 Technical Review Completed:1439 Submissions Accepted Document Review:1629 Submissions Accepted:2401 Filing Modification :939 Import Class I Device Filing:262 RFEs and Responses to RFEs RFE released: 659 RFE Response Accepted: 561 Advisory Meetings Meeting initiated: 14 Meeting …

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Guidance for registration review of prefilled catheter irrigators(Draft)

CMDE, Draft for Comments, Latest News / By Alice

On May 11, China NMPA.CMDE issued the draft guidance” Guidance for registration review of prefilled catheter irrigators”. CMDE called for public comment on the draft guidance before June 14.

48 Guidance released by China CMDE.NMPA

CMDE, Guidelines, Guiding Principles, Latest News / By Alice

On May 27, China CMDE.NMPA releases 48 guidance documents. The list is as follows: 1. Guidelines for Registration Review of Electric Photography Flat Beds 2. Guidelines for registration review of medical gas alarm systems 3. Guidelines for registration review of air-oxygen mixer products 4. Guidelines for registration review of radiotherapy laser positioning equipment 5. Guidelines …

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Guidelines for registration review of alginate dressings（Draft）

CMDE, Draft for Comments / By Alice

On April 28, China NMPA.CMDE issued the draft guidance “Guidelines for registration review of alginate dressings”. CMDE call for public comments on the draft guidance before 5th June.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

CMDE, Latest News / By Alice

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 …

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Summary of medical device technical review in February 2024

CMDE, NMPA News / By Alice

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)

CMDE, Draft for Comments, Guidelines, Guiding Principles / By Alice

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

CMDE / By Alice

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) …

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China CMDE FAQ

CMDE, Frequently Asked Questions / By Alice

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 …

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Summary of medical device technical review in March 2024

CMDE, Technical Review / By Alice

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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