CMDE

China CMDE Medical Device Registration Review Guidelines Preparation Plan in 2024

CMDE, Guidelines, Guiding Principles, Technical Review / By Alice

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 Adjust Management Method of the Electronic Declaration Information System (eRPS) for Medical Device Registration

CMDE, Guidelines / By Alice

Recently, China CMDE adjusts the digital certificate management method as follows: Starting from April 15, 2024, the management of CA certificates and other matters will be transferred to the CA certificate issuing agency (Beijing Digital Certification Co., Ltd.). CA certificate applications, information changes, renewals, renewals and re-issuances, etc., shall be handled by the medical device …

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Announcement on the arrangements for Pre-Submission Communication from May to June 2024 (No. 18, 2024)

CMDE, Latest News / By Alice

CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department May 10, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept May 17, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics May 24, 2024 Dept 3/4 /5 of Technical Review May 31, 2024 …

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Guidelines for Registration Review of Acellular Matrix Soft Tissue Wound Repair Materials Products (Draft)

CMDE, Draft for Comments, Guidelines / By Alice

On April 11st, 2024, China CMDE. NMPA issued “Guidelines for Registration Review of Acellular Matrix Soft Tissue Wound Repair Materials Products (Draft)”. CMDE called for public comments on the guidelines before May 10th.

Guidelines for Substantial Equivalence Review —clinical evaluation of absorbable surgical sutures

CMDE, Guidelines, Guiding Principles / By Alice

On April 10,2024, China CMDE.NMPA released Guidelines for Substantial Equivalence Review —clinical evaluation of absorbable surgical sutures (2024 No.15). Contact us for original documents.

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

CMDE, Interpretation, Technical Review / By Alice

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 issue a public call for participating companies in the medical device clinical evaluation industry standard formulation project

CMDE, Latest News / By Alice

On April 3, 2024, CMDE issued a notice to publicly solicit participating companies in the medical device clinical evaluation industry standard formulation project. Standards to be initiated or modified in 2024： Qualification for the applicants: Companies interested in participating in the compilation work are requested to fill in the “2024 Medical Device Clinical Evaluation Industry …

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Interpretation of product classification regarding radiofrequency (RF) therapy devices and radiofrequency (RF) skin therapy devices

CMDE, Interpretation / By Alice

According to Announcement No. 30-2022, RF therapy and RF skin therapy devices (Product code #09-07-02) shall be regulated as Class III medical devices. Announcement No. 30-2022 mainly provided new requirements of the classification and regulation of RF devices intended to be used in the aesthetic field. The following aspects represent the current thinking of NMPA. …

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China CMDE call for public comments on 3 Draf Guidelines

CMDE, Draft for Comments, Guidelines / By Alice

On March 25, 2024, China CMDE has compiled three medical device registration review guidelines: ” Guidelines for Registration Review –Antibacterial Performance Evaluation of Orthopedic Implants”, ” Guidelines for Registration Review –Type I Collagen Cartilage Repair Products”, and ” Guidelines for Registration Review –Oral Repair Membranes”. CMDE called for public comments on these guidelines before April …

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Guidelines for Registration Review of High-Frequency Surgical Equipment (2023 Revised Edition)

CMDE, Guidelines, Guiding Principles / By Alice

On March 26th, 2024, China CMDE.NMPA released “Guidelines for Registration Review of High-Frequency Surgical Equipment “(2023 Revised Edition). Contact us for the original document.

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