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Information related to medical device registration licenses in China

NMPA News / By

As of May 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 9475 4476 792 712 2856 44544 …

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4 Medical Device Registration Certificates Were Cancelled by China NMPA

NMPA, NMPA News / By

China NMPA canceled a total of 4 medical device registration certificates of the following 3 companies based on their applications. (1)Brain aneurysm clip, Registration Certificate Number: 国械注准20163131005. (2)Titanium mesh screw system for skull repair, Registration Certificate Number: 国械注准20173130706. (1) Zirconia ceramic blocks for all-ceramic dentures, Registration Certificate Number:国械注进20222170163. (1) Spinal Fixation System, Registration Certificate Number: …

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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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Announcement of e-Notice of Medical Device Registration

Announcement, CMDE, NMPA, NMPA News / By

NMPA has launched the e-Notice system regarding medical device registration decision starting from June 1, 2024, according to Announcement #68, 2024. The documents include Reject to Registration, Termination of Submission Review, Reject to IFU Modification, etc. Applicants can search the submission review status of in the NMPA Portal. The above e-Notice has the same legal …

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Summary of medical device technical review in April 2024

CMDE, NMPA, NMPA News / By

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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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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Information related to medical device registration licenses in China

Uncategorized / By

As of April 30, 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 9522 4326 818 714 2859 44322 …

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