Laws and regulations

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"

EU Declaration of Conformity FFP2 NR 

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

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;