CMDE

Batch of Innovative Medical Devices Undergoes Special Review Process 

Announcement, CMDE, Latest News / By

Document Number: No. 1 of 2024  On January 22, 2024, the China CMDE announced that seven innovative medical devices, including the cardiac pulse electric field ablation system of Insight Lifetech Co., Ltd., and the interventional ventricular assist system of Xinqing Medical (Suzhou) Co., Ltd., have entered the special review process.  Special Instruction: Entry into the …

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The China CMDE has released a draft of the Guideline for the Registration review of Monkeypox Virus Nucleic Acid Detection Reagents 

CMDE, Draft for Comments, Guidelines, Latest News / By

Date Issued: January 18, 2024  This guideline outlines the essential criteria for monkeypox virus nucleic acid detection reagents. Applicants must assess the applicability based on the specific characteristics of their product. If the guideline is not applicable, it is imperative to provide rationale and the corresponding scientific basis. Additionally, applicants should enhance and refine the …

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The China CMDE issued guideline for real-world research design and statistical analysis of medical devices

Announcement, CMDE, Guidelines, Latest News / By

Document Number：No. 3, 2024 Date Issued:  January 15, 2024 To further guide the standardized development of real-world research on medical devices, CMDE has formulated this guideline. It serves as a guiding document for registration applicants and technical reviewers. This guideline applies to real-world research on medical devices but is not applicable to real-world research on IVD( in vitro diagnostics）. …

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China CMDE has issued 613 guidelines for medical device registration review

CMDE, Guiding Principles / By

Release date:2024-01-09 The Guiding Principles for Medical Device Registration Review (hereinafter referred to as the Guiding Principles), as a new tool, method, and standard for medical device technical evaluation, play an important role in improving scientific evaluation capabilities and promoting the high-quality development of the industry. CMDE adheres to the principle of scientificity and constructs a …

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