At a State Council policy briefing held on August 1, Jiang Deyuan, a drug inspector from the Medical Device Registration Management Department of the National Medical Products Administration, stated that medical devices with Chinese invention patents, representing domestic innovation, and demonstrating significant clinical application value internationally will be given priority review through a special approval channel. 
 
　　It is understood that the National Medical Products Administration has formulated and implemented a special approval procedure for innovative medical devices, enabling products entering this channel to reduce their registration time by 83 days compared to similar products. 
 
　　By the end of June 2019, a total of 222 products had applied to enter this channel, with 65 products already approved for marketing. Among them, 64 are domestically produced products, including high-value medical consumables such as branch-type aortic covered stents and interventional artificial bioprosthetic heart valves. 
 
　　In fact, to optimize the approval and review of medical devices and promote innovation in the industry, relevant support policies and measures have been continuously introduced in recent years. 
 
　　For example, the National Medical Products Administration requires priority approval for clinically urgently needed products, accelerating product launch. This includes key research and development plans under the National Science and Technology Major Projects, focusing on medical devices for diagnosing or treating rare diseases, malignant tumors, diseases specific to or frequently occurring in the elderly, and those specifically for children, as well as clinically urgently needed medical devices. 
 
　　Simultaneously, to promote the innovation of medical devices, on August 1 this year, the National Medical Products Administration issued the "Notice of the National Medical Products Administration on Expanding the Pilot Program for the Medical Device Registrant System," expanding the pilot program, previously conducted in Shanghai, Tianjin, and Guangdong, to 21 regions including Beijing, Tianjin, and Hebei. 
 
　　The benefits of the medical device registrant system are that it decouples product registration from production licenses, significantly improving the efficiency of corporate innovation and R&D and stimulating innovation. 
 
　　In addition, the "Reform Plan for the Governance of High-Value Medical Consumables" has recently been implemented. In the next 1-2 years, it will streamline the pricing system for high-value medical consumables, improve the full-process supervision and management of high-value medical consumables, and purify the market environment for high-value medical consumables and the medical service practice environment, continuously regulating the high-value consumables industry. 
 
　　According to the plan, by the end of 2019, the first batch of key governance lists will be completed, the centralized procurement of high-value medical consumables will be launched, and surcharges on medical consumables will be canceled. In 2020, a national unified classification and coding system for high-value medical consumables under medical insurance will be developed, a price monitoring and centralized procurement management platform for high-value medical consumables will be established, a basic medical insurance access system for high-value medical consumables will be established, and circulation management will be strengthened. 
 
　　Overall, the future development of China's medical device industry will show two major trends. On the one hand, the upgrading of consumption levels and the increase in the aging population will bring great development opportunities to the entire medical device industry. 
 
　　On the other hand, the industry will face fierce competition in the future. With the support of innovative policies and a favorable innovation environment, the medical device industry will develop towards innovation. 
 
　　Jiang Deyuan mentioned that, in clinical practice, a considerable number of mid-to-high-end medical devices have been domestically produced, gradually replacing imported products. From the perspective of clinical product quality, they have generally been well-received by patients, and their prices offer some advantages over imported products. Transcatheter interventional valves, coronary drug-eluting stents, and orthopedic implants have essentially replaced imported products, with excellent clinical outcomes. 
Article Link: Pharmaceutical Network http://www.zyzhan.com/news/detail/74956.html