The medical devices are expected to enter the special approval channel and achieve priority approval!

[pharmaceutical network industry trends] at the regular policy briefing held by the State Council on August 1, Jiang Deyuan, the drug inspector of the Department of medical device registration and management of the State Drug Administration, said that medical devices with invention in China and technological innovation in China, and with significant clinical application value in the international market, entered the special approval channel for priority approval It is reported that the State Food and drug administration has formulated and implemented special approval procedures for innovative medical devices, and the time limit for products registered in this channel can be reduced by 83 days compared with other similar products As of the end of June 2019, a total of 222 products have applied to enter this channel, and 65 products have been approved for marketing Among them, there are 64 domestic products, including high-value medical consumables such as branch type aortic coated stent and interventional artificial biological heart valve In fact, in order to optimize the examination and approval of medical devices and promote the innovation and development of the industry, relevant supporting policies and measures have been launched in recent years For example, the State Food and drug administration requires that priority be given to the examination and approval of products urgently needed in clinical practice, so as to speed up the product launch Among them, the key R & D plans of the major national science and technology projects include the diagnosis or treatment of rare diseases, malignant tumors, unique and multiple diseases of the elderly, medical devices specially used for children, and medical devices urgently needed in clinical At the same time, in order to promote the innovation and development of medical devices, on August 1 this year, the State Drug Administration issued the notice of the State Drug Administration on expanding the pilot work of medical device registrant system, expanding the original pilot in Shanghai, Tianjin and Guangdong to 21 regions, including Beijing, Tianjin and Hebei The advantage of medical device registrant system is to untie product registration and production license, which greatly improves the efficiency of enterprise innovation and R & D, and stimulates enterprise innovation vitality The implementation of electronic declaration of medical device registration has also changed the preparation of declaration in the past The whole process of declaration, acceptance, review and approval has brought convenience to enterprise declaration In addition, the reform plan for the treatment of high-value medical consumables has been implemented recently In the next 1-2 years, the price system of high-value medical consumables will be straightened out, the whole process supervision and management of high-value medical consumables will be improved, the market environment of high-value medical consumables and the practice environment of medical services will be purified, and the industry of high-value consumables will be standardized   According to the plan, by the end of 2019, we will complete a batch of key treatment lists, start the centralized purchase of high-value medical consumables, cancel the addition of medical consumables, etc in 2020, we will formulate and unify the classification and coding of high-value medical consumables for national medical insurance, establish a price monitoring and centralized purchase management platform for high-value medical consumables, establish a basic medical insurance access system for high-value medical consumables, strengthen circulation management, etc 。 In general, the medical device industry in China will present two development trends in the future On the one hand, the upgrading of consumption level and the aggravation of aging have brought great development space to the whole medical device industry On the other hand, in the future, the industry competition is fierce Under the background of favorable innovation policies and environment, the medical device industry will develop towards innovation Jiang Deyuan mentioned that, especially in clinical practice, a large number of medical devices have been localized and gradually replaced by imported products Moreover, from the perspective of clinical product quality, they are generally recognized by patients, and the price has some advantages over imported products Such as transcatheter interventional valves, coronary drug-eluting stents, orthopedic implants, basically replaced imported products, with very good clinical effect.