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Information related to medical device registration licenses in China（As of July 31）

Latest News, NMPA, NMPA News / By

As of July 31st, the medical device licensing and filing information in China provinces is as follows: No. Provinces Domestic medical device products Medical Device Manufacturing Medical device Distribution On-Line Sales Filing Third-Party Platform for Medical Device Sales Registration Registration License（pcs） Filing（pcs） Permit（pcs） Filing（pcs） Permit （pcs） Filing（pcs） 1 Beijing 9589 4701 771 716 2872 45088 …

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Guidelines for Registration Review of Carbon Dioxide Laser Therapy Devices

CMDE, Guidelines, Latest News / By

China CMDE is starting the preparation of the “Guidelines for Registration Review of Carbon Dioxide Laser Therapy Devices”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate. Companies interested in participating in the …

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48 Guidance released by China CMDE.NMPA

CMDE, Guidelines, Guiding Principles, Latest News / By

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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[China NMPA.CMDE]Review time of submissions for registration completed and transferred in March 2024

CMDE, Latest News / By

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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Announcement on the arrangements for Pre-Submission Communication from May to June 2024 (No. 18, 2024)

CMDE, Latest News / By

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 …

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Information related to medical device registration licenses in China

Latest News, NMPA News / By

As of March 31, 2024，the medical device licensing and filing information in China provinces is as follows: No. Provinces Domestic medical device products Medical Device Manufacturing Medical device Distribution On-Line Sales Filing Third-Party Platform for Medical Device Sales Registration Registration License（pcs） Filing（pcs） Permit（pcs） Filing（pcs） Permit （pcs） Filing（pcs） 1 Beijing 9549 4194 817 710 2832 44041 …

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China CMDE issue a public call for participating companies in the medical device clinical evaluation industry standard formulation project

CMDE, Latest News / By

On April 3, 2024, CMDE issued a notice to publicly solicit participating companies in the medical device clinical evaluation industry standard formulation project. Standards to be initiated or modified in 2024： Qualification for the applicants: Companies interested in participating in the compilation work are requested to fill in the “2024 Medical Device Clinical Evaluation Industry …

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