Alice

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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Review time of submissions for registration completed and transferred in June 2024（CHINA CMDE）

CMDE / By

Remark： 1.The time in this table is working days. 2.Average time of deficiency response = total time of deficiency response /total number of completed and transferred submissions with deficiencies.  3.Total time = average review time+ average time of expert consultation + average time of deficiency response. 4.Average time for Class II and III products = …

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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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Two guidelines are solicited for participating units

CMDE, Guidelines / By

CMDE is soliciting participation in the revision and preparation of the “Guidance for Registration Review of Platelet-rich Plasma Preparation Device” and the “Guidance on Conditional Approval of Medical Devices (2024 Revised Edition)”. It invites domestic and foreign manufacturers, research institutions, and clinical institutions with relevant experience to actively participate. Interested parties are invited to fill …

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Announcement on the arrangements for Pre-Submission Communication from July to August 2024 (No. 22, 2024)

Announcement, CMDE / By

CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department July 5, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics (Video) July 12, 2024 Dept 3/4 of Technical Review Dept 5 of Technical Review (Video) July 19, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics …

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