Guiding Principles

Preparation of “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents”

CMDE is starting the preparation of the “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents” and “Guideline for Registration and Review of Human Leukocyte Antigen (HLA) Gene DNA Typing Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research …

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China CMDE has issued 613 guidelines for medical device registration review

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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