Announcement

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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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 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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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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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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Preparation of “Guiding Principles for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)”

Announcement, CMDE, NMPA, NMPA News, Others / By

CMDE is starting the preparation of the “Guideline for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)”, “Guideline for Registration Review of Glucose-6-Phosphate Dehydrogenase Detection Reagents” and “Guideline for Registration Review of Enzyme Detection Reagents Traceability” . Companies participating in the preparation work are now being solicited, and domestic and foreign production …

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Announcement on the arrangements for Pre-Submission Communication from March to April 2024 (No. 9, 2024)

Announcement, CMDE, Technical Review / By

CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department March 1, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics March 8, 2024 Dept 3/4 /5 of Technical Review   March 15, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept March 22, …

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China NMPA Announcement on the Release of 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”(No. 16, 2024)

Announcement, NMPA, NMPA News, Standard / By

On February 7, 2024, China NMPA released 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”. The following is the detail information: No. Standard No. Title Status Scope of application Effective Date 1 YY 1001—2024 All glass syringes Revised This document specifies the structural type, materials, requirements, marking, packaging, transportation and storage of …

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