Source: General Administration of food and Drug Administration
To implement the "Regulations" the supervision and administration of medical devices and the "State Council on the reform of drug and medical device review and approval system" (Guo Fa, 2015, No. 44), to further strengthen the management of medical device classification, give full play to the role of experts in the medical device classification management in April 16th, the food and Drug Administration of medical device classification technology committee the establishment of professional group conference and the "medical device category" Review Conference held in Beijing. Comrade Jiao Hong, deputy director general of the CPC Central Committee, attended the meeting and delivered a speech.
The meeting read the notice on the establishment of the food and Drug Administration of medical device classification technology committee of professional group, classification technology committee set up active surgical instruments and other 16 professional groups, the first group of professional classification Technical Committee consists of 288 members, including members from clinical institutions, research institutions, senior experts and scholars, as well as the main technical personnel medical supervision of the relevant departments, members of professional coverage, with better representation and authority.
In the same period held classification Technical Committee Medical Commission on the second session of the Executive Committee, the committee considered the 2016 and 2017 summary of the work plan, and focus on the reform of medical device approval and classification management focus, hot and difficult issues, positive suggestions. Medical equipment classification Technical Committee professional group examined the medical device classification list (Revised Version), the contents of the framework and content, as well as product classification were discussed in depth. Conference research believes that the new version of the directory framework more reasonable, hierarchical structure more abundant, product coverage more comprehensive, scientific and instructive directory significantly improved.
Conference believes that the establishment of professional group classification of medical devices of the technical committee is a medical device regulatory process in our country has milepost significance of the event, to deepen the reform of medical equipment, review and approval in China is of great significance to enhance the scientific level of medical supervision, to promote the development of medical equipment industry innovation. The professional group marks the establishment of classification of medical technical committee of the completion of the formal establishment of new mechanism, classification administration of medical devices officially running, to build a scientific and unified, rigorous and efficient classification system, play a good classification provides a strong technical support in the basic role of the whole process of medical supervision.
The meeting pointed out that the classification of medical devices after the establishment of the technical committee, the main task is to review the medical category after the reform and adjustment, and undertake the daily medical classification application review demonstration, timely risk on medical devices for monitoring and evaluation, a reasonable division of product category management, dynamic adjustment of medical device classification directory.
Meeting the requirements of the professional group and Classification Committee members to actively track the latest progress of medical device classification and supervision work, give full play to their own advantages, for the classification of medical devices management more words of wisdom built, offer more pragmatic strategy. Administration of the relevant departments and units should strengthen contact with members of the communication, create good working conditions and working mechanism, ensure the quality and efficiency of Classification Committee to carry out the work, to promote the work of classification management of medical devices in China into the new stage.
Classification of medical devices and Technology Committee Executive Committee, professional group committee, the general office, equipment registration department, device supervision department, news propaganda department, division of personnel and administration of medical devices standardization management center, medical devices evaluation center and other departments and units responsible comrades attended the meeting.