CFDA: Formal implementation of medical device standard management on July 1

After review and approval by the State Food and Drug Administration Administration Bureau, on April 26, the “Administrative Measures for Medical Device Standards” was officially released, and the management measures were officially implemented on July 1. At the same time, the CFDA interpreted the management methods.

I. Background of the revision of the Measures

In 2002, the former State Drug Administration issued the “Administrative Measures for Medical Device Standards (Trial)” (Original Decree No. 31), which played a role in guiding the standardization management of medical devices in China, standardizing and standardizing standards, and promoting the implementation of standards. Positive promotion.

With the continuous development of medical device standardization work, the former State Drug Administration established a full-time organization for medical device standard management in 2010, further strengthening the organization and management of medical device standards, and the medical device standard management system has changed.

In June 2014, the State Council promulgated the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council) (hereinafter referred to as the “Regulations”), canceled the registration of product standards, clarified the legal status of product technical requirements, and changed the national standards of original medical devices. The three-level standard system consisting of industry standards and registered product standards has changed the medical device standard system.

In 2015, the State Council issued the "Opinions on Reforming the Examination and Approval System for Medical Devices for Drugs" (Guo Fa [2015] No. 44), which puts forward clear requirements for the work of medical device standards.

At the same time, in March 2015, the State Council issued the “Deepening Standardization Work Reform Plan”. In 2016, the Legislative Affairs Office of the State Council publicly solicited opinions on the "Standardization Law of the People's Republic of China (Revised Draft for Soliciting Opinions)". China's standardization system and management system are facing major adjustments. The national new standard system is gradually being built, and a new standardization pattern is taking shape.

Further implement the State Council's "Deepening Standardization Work Reform Plan" and "Opinions on Reforming the Drug Medical Device Review and Approval System" (Guo Fa [2015] No. 44) to meet the new needs of medical device supervision and industrial development, and adapt to medical device standards. In the new requirements for development, the General Administration of the People’s Republic of China has revised and revised the Measures for the Administration of Medical Device Standards.

Manual Resuscitator

Manual resuscitator,ambu bag,ambu bag mask,bag valve mask

2 MEDS TECHONOLOGY CO.,LTD , https://www.2-meds.com