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 …
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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On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”.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.
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) …
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 …
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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On April 11, 2024, CMDE released the 2024 medical device registration review guideline preparation plan. Please refer to the following list: Plan for the formulation of guidelines for registration review of Class III medical devices No. Guiding principle name 1 Guidelines for Magnetic Resonance Safety Evaluation of Medical Devices 2 Guidelines for Registration Review of …
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Recently, China CMDE adjusts the digital certificate management method as follows: Starting from April 15, 2024, the management of CA certificates and other matters will be transferred to the CA certificate issuing agency (Beijing Digital Certification Co., Ltd.). CA certificate applications, information changes, renewals, renewals and re-issuances, etc., shall be handled by the medical device …
CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department May 10, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept May 17, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics May 24, 2024 Dept 3/4 /5 of Technical Review May 31, 2024 …
On April 11st, 2024, China CMDE. NMPA issued “Guidelines for Registration Review of Acellular Matrix Soft Tissue Wound Repair Materials Products (Draft)”. CMDE called for public comments on the guidelines before May 10th.
