The National Medical Products Administration (NMPA) formulates and implements a special approval procedure for innovative medical devices.

The State Council Information OfficeOn August 1, 2019 (Thursday), at 3:00 PM, the State Council held a policy briefing on the reform plan for high-value medical consumables, with Li Tao, vice director of the National Healthcare Security Administration, and heads of relevant departments introducing the situation and answering reporters' questions.

[China Daily reporter]What is the current situation of the domestic production of high-value medical consumables? What measures will the National Medical Products Administration take to further improve the domestic production of high-value medical consumables in the future?

[National Medical Products Administration, Medical Device Registration Management Department, Drug Inspection Commissioner Jiang Deyuan]The domestic production and accessibility of high-value medical consumables is a systematic project that requires the concerted efforts of relevant national departments, including the industrial sector and all aspects of society. As the functional department responsible for the supervision of medicines and medical devices, the National Medical Products Administration has earnestly implemented and implemented General Secretary Xi Jinping's series of important instructions and directives on the supervision of medicines and medical devices over the years. In accordance with the "Opinions on Reform of the Drug and Medical Device Review and Approval System" and the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices", the National Medical Products Administration has set two lines of work goals around development and supervision: resolutely safeguarding the safety bottom line of the public's use of medicines and medical devices, and striving to promote the high line of industrial innovation development. Focusing on industrial innovation development, including the innovative development of high-value consumables, a series of work measures have been taken over the years, mainly in four aspects:

First, the National Medical Products Administration formulated and implemented a special approval procedure for innovative medical devices to accelerate the registration of innovative devices. Medical devices with Chinese invention patents, which are domestically pioneered in technology, are internationally leading, and have significant clinical application value, will Enter the special approval channel for priority approval. After Entering this channel, early intervention, dedicated personnel responsibility, and full guidance are mainly adopted, giving priority to review and approval without lowering standards or reducing procedures. Statistically, since the implementation of this measure, the time limit for products Entering this channel is reduced by 83 days compared with similar products. Since the implementation of this system in 2014, a total of 222 products have applied to Enter this channel by the end of June this year, and 65 products have been approved for listing so far. Among them, 64 are domestically produced products, accounting for 98.5% of the total products, including high-value medical consumables, such as branched endovascular aortic stent grafts and interventional artificial biological heart valves. This is the first measure taken by the state.

Second, priority review is given to products that are urgently needed clinically, accelerating product listing, including medical devices involved in major national science and technology projects and key research and development plans, medical devices for the diagnosis or treatment of rare diseases, malignant tumors, diseases unique to and common in the elderly, and medical devices specifically for children, and medical devices urgently needed clinically. Priority is given to the approval of these medical devices. Since the implementation of this system in 2016, 8 products have been approved for marketing, including high-value medical consumables such as drug-eluting balloon catheters and hollow fiber membrane hemodialysis filters.

Third, the National Medical Products Administration implements a pilot program for the registration system of medical devices. In the past, the registration and production license of medical device products were bundled together. The core change of the registration system is to unbundle the product registration and production license, which can greatly promote the vitality of innovation and research and development and optimize resources. Last year, with the approval of the State Council, we piloted the program in Shanghai, Tianjin, and Guangdong. Judging from the pilot program, the results have been very good, and 13 products have been approved for listing through this method.

Fourth, implementing the State Council's reform of "delegating power, streamlining administration, and improving service," we implemented electronic filing for medical device registration, further improving review efficiency. Since June 24 this year, we have officially launched the implementation of electronic filing, acceptance, review and approval for the entire process of medical device registration, changing from paper materials to electronic materials. After the implementation of this measure, not only has the process been optimized and efficiency improved, but more importantly, it has also made it easier for enterprises.

The measures taken by the National Medical Products Administration over the years to promote innovative development have not only optimized the review and approval work of medical devices, improved the quality and efficiency of work, but also promoted industrial innovation. Looking back over the years, through the joint efforts of relevant departments and the industry, the development of China's medical device industry has shown two positive trends: First, the entire industry has maintained high-speed growth, far exceeding the overall development level of the national economy. Second, the momentum of innovation is very rapid. In particular, a considerable number of mid-to-high-end medical devices have been domestically produced and gradually replaced imported products in clinical practice, and from the perspective of the clinical product quality, they have also been widely recognized by patients, and the Price is somewhat advantageous compared to imported products. For example, transcatheter interventional valves, coronary drug-eluting stents, and orthopedic implants have basically replaced imported products, and the clinical effect is very good.

Of course, there is still a distance to the full domestic production of high-value medical consumables, and we need to continue to work hard in this area, and at the same time, we need the joint efforts of all parties.