Hello, the "Special Approval Procedure for Innovative Medical Devices (Trial)" was released
Policy review on February 7, in order to ensure the safety and effectiveness of medical devices, encourage medical device research and innovation To promote the promotion and application of new medical device technologies and promote the development of the medical device industry, the State Food and Drug Administration has issued the "Special Approval Procedures for Innovative Medical Devices (Trial)" to give priority to innovative medical devices.
Comments Compared with developed countries, my country’s medical device innovation capabilities are insufficient, the innovation support system is weak, the number of core patents is small, the level of product research and development is relatively low, and high-end products are still based on Mainly imitation and improvement. Insufficient innovation capabilities
have seriously restricted the development of my country's medical device industry. To promote the development of my country's medical device industry to a higher level, it is urgent to improve innovation capabilities. The promulgation of the "Special Approval Procedure for Innovative Medical Devices (Trial)"
will play a positive role in encouraging research and innovation in medical devices, promoting the promotion and application of new medical device technologies, and promoting the development of the medical device industry.
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Carry out the "Five Rectification" special actions for medical devices
Policy Review On March 17, the State Administration of China announced in its It was announced at the press conference: In order to solve the hot and difficult issues of medical devices that have attracted high social attention and strong public feedback, further regulate the market order, and severely crack down on illegal activities, the State Administration of China has decided to start from March Starting from the middle of the year, a five-month special campaign of "five rectifications" of medical devices will be carried out across the country, focusing on rectifying false registration declarations, illegal production, illegal operation, exaggerated propaganda, and use of unlicensed products, etc. five behaviors. During the "Five Rectifications" period, food and drug regulatory agencies at all levels investigated and handled more than 5,300 cases of various medical devices; they also investigated and dealt with more than 160 black dens.
Comments In recent years, with the deepening of supervision, the order of my country's medical device market has improved year by year and has been continuously standardized. However, due to the late development of my country's medical device industry, the overall scale of the industry is small, the industrial foundation is relatively weak, and the safety situation is not optimistic. The implementation of the "Five Rectification" special action is not only an effective means to crack down on illegal activities, but also a powerful measure to purify market order and promote market regulation. It is important for ensuring the safety of public equipment and promoting the health of the medical device industry.
development is of great significance. At the same time, rectification can also identify problems, prevent regulatory risks, plug regulatory loopholes, enrich regulatory measures, and establish and improve long-term regulatory mechanisms.
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The "Regulations on the Supervision and Administration of Medical Devices" was promulgated
Policy Review On March 31, the newly revised "Medical Device Supervision and Administration Regulations" The Regulations on the Supervision and Administration of Devices (hereinafter referred to as the "Regulations") were announced. The Regulations came into effect on June 1. The "Regulations" have added a lot of content to support the development of the industry, and have appropriately relaxed the requirements for medical device research and development, aiming to actively promote the upgrading and innovation of medical device products. The main contents of the "Regulations" include: implementing classified management of medical devices according to the degree of risk, and classifying medical devices into categories one, two, and three according to risk
from low to high; the first category of medical devices is changed to Product registration management, Class II and III medical devices will continue to be subject to product registration management; Class I medical device production will be changed to filing management, and the production of Class II and III medical devices will continue to be subject to approval Management; liberalize the operation of first-class medical devices, change the operation of second-class medical devices to filing management, and continue to implement licensing management for the operation of third-class medical devices; encourage the operation of medical devices Research and innovation, give full play to the role of market mechanisms, promote the promotion and application of new medical device technologies, clearly implement the new regulatory model of "product registration first, then production licensing"; increase the production and operation of medical devices
Enterprises' control responsibilities in terms of product quality; strengthen the daily supervision responsibilities of regulatory authorities; enhance operability by refining penalties, adjusting penalty ranges, and increasing penalty types; and 16 items stipulated in the original "Regulations"
Administrative licenses reduced to 9 items.
Comments The promulgation of the "Regulations" is of great significance to standardize the development, production, operation and use of medical devices, strengthen the supervision of medical devices, ensure the safety and effectiveness of medical devices, and promote the development of the industry.
Especially driven by the two major policy directions of increasing supervision and encouraging innovation, the trend of survival of the fittest in the medical device industry will become more obvious, the medical device industry will become more standardized, and the pace of mergers and reorganizations will also accelerate. This will further promote the optimized combination of my country's medical device industry and thereby enhance the international competitiveness of my country's medical device products.
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Selection of excellent domestic medical equipment
Policy Review On May 26, the National Health and Family Planning Commission commissioned the China Medical Equipment Association to launch the first batch of excellent domestic medical equipment. Medical equipment product selection work. In accordance with the principles of openness, transparency, objectivity and fairness, excellent quality, perfect after-sales, combination of points and aspects, key breakthroughs, scientific classification, and dynamic adjustment, a batch of products that meet clinical needs, have excellent product quality, and have market share are selected. Domestic medical equipment with competitiveness and development potential will be formed into an excellent product catalog, and a scientific evaluation system for the application of domestic medical equipment will be gradually established to provide reference for the equipment work of national health and family planning institutions.
Taking into account factors such as domestic equipment production capacity, market development space and product utilization rate, three basic medical equipment, including digital X-ray machines, color Doppler ultrasound diagnostic machines and fully automatic biochemical analyzers, were selected as the first batch.
< p>Select an item. According to the work arrangement, the selection of other items will be carried out in due course. Not long ago, the China Medical Equipment Association released the first batch of "Selection Results of Excellent Domestic Medical Equipment Products", and the A-share listed companies selected for the first batch of excellent domestic medical equipment include: Kehua Biologics, China Resources Wantong, Di. Rui Medical, Xinhua Medical, Neusoft Group and Hejia Holdings. Products such as digital X-ray machine (DR), color Doppler ultrasound diagnostic instrument and fully automatic biochemical analyzer were selected respectively.The strategic position of Dianping medical equipment is generally recognized by countries around the world and has become one of the important symbols of a country's national economic modernization level and the modernization of its health services. This selection of outstanding domestic medical equipment carried out by our country has laid a good foundation for the localization of medical equipment. The equipment selected this time is also very representative. The three products of digital X-ray machine (DR), color Doppler ultrasonic diagnostic instrument (desktop) and fully automatic biochemical analyzer are all The most commonly used equipment in the diagnostic process, and these three types of equipment are currently mainly imported
Accelerating their localization will be of great benefit to alleviating the cost of medical treatment for the public and accelerating the development of the medical device industry. Bringing these domestically produced equipment to the market will provide a huge boost to the growth of my country's medical device companies, and is especially a major opportunity for large-scale and high-quality domestically produced medical devices. Judging from the product selection results, most of the companies selected for the catalog are excellent domestic medical equipment companies with strong technical strength and high product quality, which will greatly promote the development of national brands.
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Five regulations including the "Medical Device Registration Management Measures" were released
Policy Review On July 30, in order to cooperate with the implementation of the "Regulations", On the basis of in-depth research, multiple demonstrations, and extensive solicitation of opinions from all parties, the State Administration of China formulated and promulgated the "Measures for the Registration and Management of Medical Devices", "Measures for the Registration and Management of In Vitro Diagnostic Reagents", "Regulations on the Management of Instructions and Labels of Medical Devices", The five regulations are the "Measures for the Supervision and Administration of Medical Device Production" and the "Measures for the Supervision and Administration of Medical Device Operations", both of which came into effect on October 1, 2014.