NMPA

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

Announcement, NMPA / By

As of August 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 9640 4801 768 715 2868 44657 …

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

NMPA, NMPA News / By

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）

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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A flight inspection led to the suspension of production at one company

Announcement, NMPA / By

NMPA conducted a flight inspection of Weihai Walt Biological Technology Co., LTD. and found that the quality management system mainly had the following defects: 1. Institutional personnel 2. Quality control 3. The adverse events monitoring, analysis and improvement Because of the serious defects in the quality management system of the company, the company is ordered …

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NMPA New Approvals in June 2024

NMPA, NMPA News / By

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

Announcement, NMPA, NMPA News / By

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

Announcement, NMPA, NMPA News / By

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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