CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department November 1, 2024 Dept 3/4 of Technical Review Dept 5 of Technical Review (On-Site) November 08, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept (On-Site) November 15, 2024 Dept 1/2 of Technical Review Dept 1 of …
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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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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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 …
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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On January 18, 2024, China CMDE released guidance “Guidelines for Registration Review — IVD for Drug of Abuse” （2024 No.4）. Login for original document.
On January 23, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Registration Review — Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories ” . CMDE called for the public comments on the draft guideline before February 22, 2024.
On January 18, 2024, China CMDE released registration guidance “Guidelines for Registration Review – Clinical trials of human immunodeficiency virus detection reagents” (2024 No.4). Log in for original document.
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, …
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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