Technical Review

Summary of medical device technical review in March 2024

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The following is the summary of medical device technical review in March 2024: Submissions Overview In Process of Technical Review:1371 Technical Review Completed:1254 Submissions Accepted Document Review:1423 Submissions Accepted:2140 Filing Modification :801 Import Class I Device Filing:242 RFEs and Responses to RFEs RFE released:  607 RFE Response Accepted: 639 Advisory Meetings Meeting initiated:  12 Meeting …

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China CMDE Medical Device Registration Review Guidelines Preparation Plan in 2024

CMDE, Guidelines, Guiding Principles, Technical Review / By

On April 11, 2024, CMDE released the 2024 medical device registration review guideline preparation plan. Please refer to the following list: Plan for the formulation of guidelines for registration review of Class III medical devices No. Guiding principle name 1 Guidelines for Magnetic Resonance Safety Evaluation of Medical Devices 2 Guidelines for Registration Review of …

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Interpretation of “Guidelines for Registration Review of Medical Device Usability Engineering “

CMDE, Interpretation, Technical Review / By

China CMDE recently issued an interpretation of the guidelines for Registration Review of Medical Device Usability Engineering. In this document, China CMDE interpreted the background of the guideline. It is also to follow the medical device regulators in US and CE. Class II/III registration shall follow the guideline, but IVD is excluded. The key points …

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China CMDE.NMPA registration technical review report – Implantable wireless pacemaker

CMDE, Technical Review / By

Recently, China CMDE.NMPA published registration technical review report of Implantable wireless pacemaker. Product name: Implantable wireless pacemaker Product category: Class III Applicant name: Abbott Medical Product structure and composition: This product consists of a pulse generator with built-in battery and electrodes and a loading tool. This product is used in conjunction with programmable controllers, delivery …

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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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Summary of medical device technical review in January 2024

NMPA News, Technical Review / By

The following is the summary of medical device technical review in January 2024: Submissions Overview In Process of Technical Review:1311 Technical Review Completed:1331 Submissions Accepted Document Review:1576 Submissions Accepted:2113 Filing Modification :933 Import Class I Device Filing:187 RFEs and Responses to RFEs RFE released:  643 RFE Response Accepted: 540 Advisory Meetings Meeting initiated:  5 Meeting …

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China CMDE.NMPA registration technical review report – Composite Plate System

CMDE, Technical Review / By

Recently, China CMDE.NMPA published registration technical review report of composite plate system. Product name: Composite Plate System Product category: Class III Applicant name: CarboFix Orthopedics Ltd. Product structure and composition: This product consists of bone plates and bone screws. The bone plate is made of carbon fiber polyetheretherketone composite material. The material grade is PEEKPEEK-OPTIMA …

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