Premier Li Keqiang of the State Council chaired a executive meeting of the State Council on February 12 to consider and adopt the Regulations on the Supervision and Administration of Medical Devices (Revised Draft). The meeting pointed out that ensuring the safety and effectiveness of medical devices is of great significance for maintaining human health and life safety, improving the quality of life and promoting industrial upgrading.
"Medical care for the sick, housing for the elderly and support for the elderly" are the three livelihood topics of concern to the people. Among them, as an important support point for building the medical system, the medical device industry has attracted more and more attention. As a small-capacity industry, medical devices are not as attractive as infrastructure, finance and other industries, but the market size has exceeded 200 billion yuan from 17.9 billion yuan in 2001 to 2013. China's medical devices industry has shown great growth potential. Some institutions even predict that the market size will reach 340 billion yuan by 2015.
Behind the good situation, there are also some problems. On the one hand, compared with 42% of the global medical devices market, the proportion of medical devices in China is still very small. Domestic medical devices can not fully meet the domestic market demand, large-scale high-end medical equipment mainly depends on imports, and there is still a big gap with the world's powerful medical device industry; on the other hand, in recent years, from large to tens of millions, small to several yuan of medical devices and products, because quality problems have led to many medical treatment. Disputes: Medical equipment in some large hospitals is often "used with illness". Breathing machines and defibrillator pacemaker monitors suddenly malfunction in the process of rescuing patients; cardiopulmonary bypass machine stops in extracardiac surgery...
More distressing is the spread of rent-seeking in this industry, and the "grey black screen" has penetrated into the production, circulation and use of the three main business links. Foreign enterprises, which have always been strictly managed, have gradually become the disaster areas of bribery. In the medical equipment industry, 20% of the profits are used for commercial bribery, which is an indisputable latent rule in the industry.
The Regulations on the Supervision and Administration of Medical Devices (Revised Draft) deliberated and adopted by the Standing Meeting of the State Council will enable the supervision of medical devices to cover all aspects of registration, production and circulation, and provide safe and effective devices for a large consumer group in the whole industrial chain, which indicates that the state has thoroughly renovated medical devices. The determination of industry chaos.
"The revised draft further improves classification management according to the risk level of medical device products, raises the threshold for high-risk products, and simplifies access procedures for low-risk products." Through the way of "pressure and relaxation" and using the risk management concept, we can not only highlight the supervision of high-risk product manufacturing enterprises, but also give them a transitional period of gradual improvement, which will be conducive to further implementing the primary responsibility for the quality of medical device manufacturing enterprises and promoting the structural adjustment and industry of medical device industry. Upgrade.
For a long time, due to the lack of supervision in China's medical device industry, the disordered competition in the market is serious. The Regulations on the Supervision and Administration of Medical Devices (Revised Draft) use the means of "having receipts and releases". On the one hand, it strengthens the process supervision and daily supervision, highlights the quality control and safety management responsibilities of production and operation enterprises and users, enhances the scope of punishment for illegal acts, enhances the intensity of punishment, and maintains fairness with the system. Orderly production and operation order. On the other hand, we should further promote the transformation of government functions, encourage enterprises to innovate and develop more high-quality products, so that besides the normal growth of market size, the medical equipment industry can seize the opportunities of import substitution and upgrading and transformation, accelerate strategic planning and integration, and form a "top-notch" division of scientific research and intensive development. Exhibition.
A "safety valve" has been set up in the Regulations on the Supervision and Administration of Medical Devices (Revised Draft). In the future, the demand for medical services brought about by deep urbanization and the government-led supply of medical services will increase substantially, together with the special funds of the medical system, these factors will promote the further rapid development of the medical device industry, and the people will also get better medical services.

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