Recently, CFDA has held a Medical Device Classified Catalog Seminar in Beijing. The seminar came in three panels, on which comments and opinions of experts and scholars from medical institutions and colleges, representatives from domestic and foreign enterprises and food and drug supervisors were heard. The revision of medical device classified catalog was further improved. Jiao Hong, Deputy Director of CFDA attended the seminar。
After discussion, experts present at the seminar agreed that the catalog should conform to scientific laws, adapt to the innovative development of industry and approach to the needs of clinical applications. The preparation and revision of catalog was a long-term job. We should set up a dynamic adjustment mechanism for the catalog. Experts in relevant fields shall contribute their wisdom to the adjustment of catalog actively。
The classification of medical devices was the basis of risk management of medical devices and also an integral part of the examination and review institutional reform of medical devices. At present, the catalog has entered a critical stage. While giving policy and regulation support, CFDA also fully integrated and mobilized social resources, set up a technical committee and panel for classification, listened to the opinions of all parties and kept improving the catalog. In the next work, CFDA would continue to play a role in overall planning and coordination, analyze and evaluate risks of medical devices in time, combined with clinical use and adverse event monitoring and classify categories rationally, to better meet the use demands of the public。
