NMPA News

NMPA registration information for imported Class I medical devices in July 2024

No. Product Name Name of the filing person Production address Filing date Status 1 Screwdriver Neobiotech Co., Ltd. 104, 24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul, KOREA 2024-07-31 Change 2 Sinus Lift Kit Neobiotech Co., Ltd. 104, 24/102, 103, 104-1, 104-2, 105, 106, 205, …

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

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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NMPA New Approvals in June 2024

In June 2024, China NMPA approved 134 medical devices, including 14 Class III imported products, 11 Class II imported products, and 109 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 …

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NMPA suspends the import, operation and use of the Samo Trekking knee system & Components of hip prosthesis

NMPA organized a remote off-site inspection of SAMO S.p.A (Italy) for Trekking knee system and Components of hip prosthesis. The inspection found that Samo company in Italy did not effectively identify Chinese regulatory requirements, product technical requirements and size parameters identification errors, etc. The comprehensive evaluation concluded that it did not meet the requirements of …

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Class I imported medical devices registration information in June 2024

The class I imported medical devices registration information in June 2024 is as follows: No. Product name Filling Name Production address Filing date Status 1 Planting aids MIS Implants Technologies Ltd. Bar Lev Industrial Park, 2015600, Israel  2024-06-28 change 2 Implant Installation Aid Kit MIS Implants Technologies Ltd.  PO Box 7 Bar Lev Industrial Park, …

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Information related to medical device registration licenses in China

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

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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Announcement of e-Notice of Medical Device Registration

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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