Policy ReviewOn February 7, in order to ensure the safety and effectiveness of medical devices, encourage medical device research and innovation, 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 (SFDA) introduced the "Special Approval Procedures for Innovative Medical Devices (Trial)", which provides priority processing for innovative The State Food and Drug Administration issued the "Special Approval Procedure for Innovative Medical Devices (Trial)" to prioritize the processing of innovative medical devices.
Points out that compared with developed countries, China's medical device innovation capability is insufficient, the innovation support system is weak, the number of core patents is small, the level of product research and development is relatively low, the high-end products are still based on imitation and improvement.
Insufficient innovation capacity has seriously constrained the development of China's medical device industry. To promote the development of China's medical device industry to a higher level and higher level, it is urgent to improve the innovation ability. The introduction of Special Approval Procedures for Innovative Medical Devices (for Trial Implementation)
has a positive effect on encouraging the research and innovation of medical devices, promoting the popularization and application of new medical device technologies, and promoting the development of the medical device industry.
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To carry out the medical device "five rectification" special action
Policy review March 17, the State Administration of the press conference held in its briefing: In order to solve the social concern, the public reflected the strong medical device hotspot, the difficult problem, and to further To standardize the market order and crack down on illegal behaviors, the State Administration decided to launch a five-month medical device "Five Rectification" special action since mid-March, focusing on medical device false registration, illegal production, illegal
management, exaggerated publicity, and use of unlicensed products and other five behaviors. The five behaviors of unlicensed products. During the "five rectification" period, food and drug regulatory agencies at all levels investigated and handled more than 5300 cases of various types of medical devices; investigated and dealt with more than 160 black spots.
Points out that in recent years, with the deepening of supervision, China's medical device market order is improving year by year, and constantly standardized. However, due to the late start of the development of China's medical device industry, the overall scale of the industry is relatively small, the industrial base is relatively
weak, the security situation is not optimistic. The "five rectification" special action to carry out, not only to crack down on illegal behavior of the effective means, but also to purify the market order, promote the market standardization of a powerful initiative to protect the public with the safety of medical devices,
Promote the healthy development of the medical device industry is of great significance. At the same time, through the rectification can also find problems, prevent regulatory risks, plug regulatory loopholes, rich regulatory measures, establish and improve the long-term regulatory mechanism.
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The promulgation of the Regulations for the Supervision and Administration of Medical Devices
Policy ReviewOn March 31st, the newly revised Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as "the Regulations") was announced. The Regulations came into effect on June 1st. The Regulations add a lot of support for the development of the industry
and appropriately relax 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: the implementation of classification management of medical devices in accordance with the degree of risk, according to the risk
from low to high medical devices are divided into one, two, three; the first class of medical devices into product filing management, the second class, the third class of medical devices to continue to implement the management of product registration; the production of first class of medical devices into the management of the filing,
second class, the third class of medical device production continues to implement the management of approval; first class of medical devices production into the management of filing,
second class, the third class of medical devices Production continues to implement the approval of management; liberalization of the operation of Class I medical devices, the operation of Class II medical devices into the record management, the operation of Class III medical devices continue to implement the licensing
management; encourage research and innovation of medical devices, play the role of the market mechanism, to promote the promotion and application of new technologies for medical devices, the clear implementation of the "product registration, after production licensing" of the first
Medical device research and innovation is encouraged to play a role in the market mechanism to promote the promotion and application of new technologies in medical devices, the implementation of the "first product registration, after the production license" of the new regulatory model; increase medical device production
Production and operation of enterprises in product quality control responsibilities; strengthen the daily supervision of the regulatory authorities; through the refinement of penalties, adjusting the range of penalties, penalties, and increase the types of enhance the operability of the original "Regulations" of the 16
Administrative licensing is reduced to 9.
Commenting on the introduction of the Regulations, it 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 in the increase in supervision, encourage innovation under the impetus of the two policy guidance, the medical device industry, the trend of survival of the fittest will be more obvious, the medical device industry will be more standardized, mergers and acquisitions will speed up the pace of reorganization. This will further promote China's medical device industry to optimize the combination, and then enhance the international competitiveness of China's medical device products.
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Selection of excellent domestic medical equipment
Policy ReviewMay 26, the National Health and Family Planning Commission commissioned the China Medical Equipment Association to start the first batch of excellent domestic medical equipment products selection work. In accordance with the principles of openness, transparency, objectivity and fairness, good quality and perfect after-sales service, combination of point-face and key breakthroughs, scientific classification and dynamic adjustment, a batch of domestically produced medical equipment that meets the clinical needs, has excellent product quality, market competitiveness and development potential will be selected to form a catalog of products of excellence, and to establish a scientific evaluation system of the application of domestically produced medical equipment, so as to provide the best possible solution for the equipping of the nation's healthcare institutions and to improve the quality of medical equipment.
Provide reference for the work of national health planning organizations. Taking into account factors such as the capacity of domestic equipment, market development space and product utilization rate, three types of basic medical equipment, including digital X-ray machines, color Doppler ultrasound diagnostic instruments and automatic biochemical analyzers, were selected as the first batch of selected items
. According to the working arrangement, will also be carried out in due course of other items selection work. Not long ago, China Medical Equipment Association released the first batch of "excellent domestic medical equipment product selection results", selected for the first batch of excellent domestic medical equipment
A-share listed companies are: Kewa Biotechnology, CR Vanton, DirecTV, Xinhua Medical, Neusoft Group and Hejia shares. Digital X-ray machine (DR), color Doppler ultrasound diagnostic instrument and automatic biochemical analyzer were selected respectively.
Review of the strategic position of medical equipment is widely recognized by countries around the world, and has become one of the important symbols of the modernization level of a country's national economy
and the modernization and development of health undertakings. China's excellent selection of domestic medical equipment for the localization of medical equipment has laid a good foundation. This selection of equipment is also very representative
table, digital X-ray machine (DR), color Doppler ultrasound diagnostic instrument (desktop) and automatic biochemistry analyzer are now the most commonly used diagnostic equipment, and these three types of equipment is mainly imported
based on accelerating the localization of the people to alleviate the high cost of medical care and accelerate the development of medical equipment industry are The new technology will help to reduce the cost of medical treatment and accelerate the development of the medical device industry. Putting these domestic devices on the market will bring great help to the growth of China's medical device enterprises, especially for large-scale superior
show domestic medical devices is a major opportunity. From the product selection results, most of the companies selected for the catalog are excellent medical equipment companies with strong domestic technical strength and high product quality, which will greatly promote the development of national brands
Development.
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"Measures for the Administration of Registration of Medical Devices" and other five regulations issued
Policy ReviewJuly 30, in order to cooperate with the implementation of the "Regulations", in-depth research, repeated demonstration, and on the basis of extensive consultation with all parties, the State General Administration of the formulation and promulgation of the "Measures for the Administration of Registration of Medical Devices", "Measures for the Registration of In Vitro Diagnostic Reagents", "Regulations on the Management of Medical Device Instructions and Labeling Regulations", "supervision and management of the production of medical devices", "supervision and management of medical devices" five regulations, and all on October 1, 2014 came into force.