State Council: focus on promoting the standardization of medical equipment, the industrial pattern will change

Release time:

2018-08-07

The General Office of the State Council recently issued the "National Standardization System Construction and Development Plan (2016-2020)" (hereinafter referred to as the "Plan") to deploy and promote the implementation of the standardization strategy, accelerate the improvement of the standardization system, and comprehensively improve my country's standardization level. The plan is clear.Medical DevicesIt is the focus of industrial standardization. This is the first national special plan in the field of standardization in China.

The Plan identifies five key areas of standardization work: first, to strengthen the standardization of economic construction to support transformation and upgrading and structural adjustment; second, to strengthen the standardization of social governance to ensure and improve people's livelihood; third, to strengthen the standardization of ecological civilization and serve green development; fourth, to strengthen the standardization of cultural construction and promote cultural prosperity; fifth, to strengthen the standardization of government management, promote streamlining administration and decentralization, standardize administrative examination and approval, and improve administrative efficiency.

　　Industrial Standardization Focus: Medical Devices

The "Plan" requires the development of standardization work in the fields of biomedical engineering, new medical materials, high-performance medical equipment, medical robots, household health monitoring and diagnosis equipment, advanced life support equipment, and traditional Chinese medicine characteristic diagnosis and treatment equipment.

Medical devices are widely used in disease prevention, diagnosis, treatment, health care and rehabilitation. It is an important diagnosis and treatment method in the field of modern medicine. Its industrial development involves a series of cutting-edge technologies such as materials, computers, machinery, information, biology, and medicine. It is currently the most Emerging industries with growth potential, and the strategic position of the medical device industry has been paid much attention in various countries.

How to ensure the effective use of medical devices is the most concerned issue for management departments, manufacturers and users of medical devices. The effective use of medical device products depends on reasonable product design and continuous and stable quality system assurance. These two aspects are inseparable from the support of medical device standards. Medical device manufacturers ensure that products meet regulatory requirements and ensure that products are effective by implementing relevant medical device standards and complying with corresponding medical device standards.

　　Focus of standardization in the social field: basic medical and health care

In addition, the Plan also requires the revision of health, Chinese medicine-related standards, including health information, medical institution management, medical services, TCM characteristic diagnosis and treatment services and "preventive treatment of disease" preventive health services, clinical testing, blood, hospital infection control, nursing, infectious diseases, parasitic diseases, endemic diseases, vector biological control, Occupational health, environmental health, radiation health, nutrition, school health, disinfection, health emergency management, health quarantine and other fields.

Formulate important related product standards, including Chinese herbal medicine seed and seedling standards, Chinese herbal medicine and Chinese herbal medicine grading standards, and authentic medicinal materials certification standards to improve the fairness, accessibility and quality of basic medical and health services.

　　Industrial pattern or major changes

Wei Shaofeng, co-chairman of the China Association for the Promotion of Medical Devices, said in an interview with Chinese medical devices that standardization is an important means of industrial competition and international competition, and an important symbol of improving industrial progress. The medical device industry has long been multiple, small, scattered, and chaotic. The status quo is accompanied by the high-level competition form-the advent of the era of intellectual property competition with standardization as an important part of the organization, china's medical device industry will usher in major changes, and those companies that set standards will undoubtedly be the king of the market.

However, it is not only large enterprises that can formulate standardization. The market is still relatively fair. After competitive small and medium-sized enterprises have first-class technology and standards, they can also raise corporate standards to national standards through various methods, thereby raising the barriers to entry for competitors. Market competition wins time.

　　Conclusion

The rapid development of medical device industry is inseparable from the standardization of medical devices. At present, many countries and enterprises have taken the implementation of standard strategy as an important means to participate in international competition and enhance technological innovation. It can be said that the construction level of medical device standardization has become an important symbol to measure the modernization level of medical device industry.

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