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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"Production Supervision and Administration of Medical Devices" section (1)

First, the "medical equipment production supervision and management approach" (hereinafter referred to as the production approach) Revision of the general idea of ​​what is?
A: safe and effective medical devices relating to people's lives and health, medical equipment production process directly affects the quality and safety of the product. As one way of supporting the production regulations "Supervision and Regulation of Medical Devices"

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DWG: the 9th Annual Meeting of the German Spine Society, Leipzig

The Congress, the 9th Annual Meeting of the German Spine Society, runs under the slogan ‘Spine surgery between quantity and quality’ and responds to the critical questions posed to us as spine surgeons. Here we will adopt a clear scientific position and present ourselves as an advocate of the patient and his suffering of spinal disorders.

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