Changmei Medtech

The notification on the implementation of medical devices and in vitro diagnostic reagent registration management practices related issues-SFDA No. 247 [2015]

Provinces, autonomous regions and municipalities Food and Drug Administration:

The newly revised "Medical Device Registration" (China Food and Drug Administration Order No. 4) and "in vitro diagnostic reagent registration management approach" (China Food and Drug Administration Order No. 5) was October 1, 2014 since implementation.

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Guiding Principles for Medical Device Evaluation and revision management

Chapter I General Provisions

The first medical device to regulate the technical review guidelines (hereinafter referred to as "Guiding Principles") in the formulation and revision work to develop this approach.
Within the meaning of Article II "Guiding Principles" means the "Medical Device Registration", "in vitro diagnostic reagents Registration" (Trial), combined with China's actual medical device technology review, as

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State Council on the reform of the drug review and approval system for medical devices

In recent years, the rapid development of China's pharmaceutical industry, pharmaceutical and medical device quality standards continue to improve, to better meet the needs of public administration. At the same time, drug review and approval of medical devices in the problems have become increasingly prominent, registration data quality is not high, the review process requiring multiple complements, seriously affecting the efficiency review and approval;

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