System planning medical device standard 105 revision completed within the year


Release time:

2018-08-08

System planning medical device standard 105 revision completed within the year

Source: China Medical News

   

A few days ago, it was learned from the State Food and Drug Administration that basic work such as the revision of medical device standards in my country has been continuously strengthened. In the next step, the State Food and Drug Administration will systematically plan the construction of a medical device standard system.
In recent years, the State Food and Drug Administration has continuously increased the revision of medical device standards, the number of standards has increased significantly, and the coverage has continued to expand. By the end of 2012, there were 1051 effective medical device standards in China, including 187 national standards and 864 industry standards.
In 2013, the National Bureau will continue to strengthen the research on the standard system of medical devices and do a good job in the revision of the standard system. The Medical Device Supervision Department of the State Administration will conduct research with the Medical Device Standard Management Center of the State Administration, starting from the unified structure of the national medical device standard management, focusing on the needs of industrial development, and making full use of the resources and strength of relevant departments to systematically plan the construction of the medical device standard system, Continue to complete the revision of 105 medical device industry standards according to the annual plan. 
The National Bureau will also study and formulate the management requirements for the revision of medical device standards (including standard material research), seriously guide and supervise the implementation of the project, and do a good job of review and release in a timely manner.