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August 30, 2011, medical supervision and management workshop held in Beijing, the State Food and Drug Administration committee member, deputy director-side Zhenjia attended the meeting. Policy and Regulation Department, medical supervision of the Secretary, Chinese Institute of Food and Drug Testing, Medical Device Standards Management Center, Drug Certification Center, Center for Drug Evaluation, Medical Center for technical review and the staff attended the meeting. Units and departments were reported on the recent work on the current problems and the next task in-depth discussions.

A side vibration that year, the National Bureau of Medical Devices regulatory relevant departments and units, in accordance with the functions and work requirements, combined with their actual, actively think of ways to seek ideas and take effective measures to conscientiously implement the Party Group of the deployment and work plan , the work and have achieved good results. Approval of medical devices in particular, review the basic issues have been resolved out. However, with advances in medical technology, medical industry and the diversification of production and management, medical supervision is facing many new challenges and opportunities, medical device regulatory laws and regulations, registration management system, inspection system, information technology other aspects remain to be improved, monitoring team and the ability to continue to be strengthened.

A side of vibration stress, departments and units to in-depth analysis of medical device regulatory work in the situation, actively seize and make good use of the “second five” important development opportunities, and properly deal with a variety of risks and challenges, efforts to improve medical device safety standards . In regulation, the foster innovation, truly change; adjust the regulatory focus, good product stewardship focus; focus on policy effectiveness, increased training efforts; strengthening of qualified personnel, and effectively improve the regulatory capacity; detailed emergency management measures, good emergency management; strengthen policy research, medical device regulatory strategies to complete a good research topic. In the management mechanism, the National Bureau of units and departments, to further strengthen the supervision of local guidance, to further improve communication and coordination mechanism, the formation of a monitoring force.

A side vibration requirements, the units should carefully combing session of advice and measures, in-depth study of medical supervision of the situation and tasks facing the proposed short-term and long-term improvement measures to ensure that medical supervision of healthy and sustainable development.

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New model of medicine has brought new opportunities for medical device regulation
Aerospace technology, new materials, digital information technology and other new technologies, the rapid development and the different technologies between the increasingly integrated in the promotion of medical device industry developed rapidly, to meet public health needs, the medical device industry and regulators have formed a new opportunities and new challenges.
China Academy of Engineering, Yu Meng-sun, vice chairman of China Association of Medical Equipment and other insiders have pointed out that Dai Jianping, a gradual shift from the medical model is disease-centered to changes in the health center, rapid economic development, new medical reform to increase investment and residents increasing emphasis on health, both medical device industry will bring tremendous opportunities and broad space for development. Changes in the industry and at the same time, medical supervision should be adjusted accordingly ideas.
Regulatory and industrial development are mutually reinforcing aspects. State Food and Drug Administration (SFDA) A deputy director-side vibration that the medical equipment industry s rapid development, to the supervision brought many new opportunities and challenges. With the protection of armed security people on the basis of this fundamental, regulatory authorities will provide the policy support, management and information services, and promote further standardize the market order for the industry to create a healthy sustainable environment.

New model brings new opportunities
With the sustained rapid growth, new medical reform in the government to increase investment to strengthen primary health care institution-building, people s health conscious and aging population, under the influence of various factors, the medical device industry ushered in unprecedented opportunities for development. Qilu Securities analysts believe the next three years, the global medical device growth is expected at 4% to 6% in 2011, global medical device market will reach $ 312 billion, while the expansion of China s market growth rate will reach 20%. Among them, the home medical equipment will show a rapid development momentum, is expected to portable home medical equipment industry in the next three years, the overall growth rate of 30% or more.
Although in recent years, China s medical device industry was the rapid development, but with the international advanced level, there are still a considerable gap. Yu Meng-sun that, in accordance with disease-centered medical model, China s medical device industry to reach the world advanced level is very difficult to recover the greater the gap even more. The current development of China s medical device industry to a turning point, may lead to better medical direction, may also lead a bad direction. Only by changing the medical model, to play China s inherent advantages, it may be changed from the catch-up leader.
In fact, medical and health industry has been aware of the disease-centered model of medical limitations. World Health Organization made it clear that the medical center should shift to the disease-health center. This medical device industry, pointed out the direction for future development. Accordance with the health center s medical model, Yu Meng-sun that medical services in health status should be toward the identification and adjustment of the direction. Chinese traditional medicine culture is a holistic thinking, dialectical therapy, health-centered model, therefore, China has a unique advantage in this respect, if to seize this opportunity, combined with modern science and technology, China s medical device industry has may walk in the world.
Dai Jianping Yu dream Sun strongly endorses the view, and further detailed analysis of the medical pattern to bring changes in the medical device industry: from the treatment for the symptoms, to identify and conditioning for the sub-health; mainly from invasive to non-invasive, minimally invasive direction ; shift from the past for community hospital services and family services. This analysis coincides with Qilu Securities.
Dai Jianping also pointed out that medical devices have two major trends in technology, one from the digital to the network, wireless network development, and the other is the continued integration of various technologies, such as PET-CT and later appeared in PET-MR.

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To regulate and promote development
Whether the establishment of a new model of medical or health care needs of residents, driven, and new technology development and integration, these factors contribute significantly to development of the industry, but also to the regulation of medical devices has brought unprecedented challenges.

Yu Meng-sun pointed out that with the medical model changes, changes in medical device development, regulatory thinking should be adjusted accordingly, to determine the effectiveness of the product should not be disease-standard, but health status should be the standard. Dai Jianping also proposed, network technology, nuclear medicine, radiology and other fusion techniques, has brought many new problems, such as healthcare IT ethical issues, PET-MR fusion products such as nuclear medicine or radiology are , and so on. Whether it is the development of concepts, methods or techniques, gave a huge regulatory challenges,
As Dai Jianping said, development is the prerequisite for regulation, supervision is the development of protection. Mechanical security with the public, industry, health and sustainable development are inseparable from the scientific supervision. At the same time, companies have developed, standardized, it can reduce regulatory pressures and risks.
A side vibration that protect public safety with firearms is a fundamental medical device regulation. On this basis, the regulatory authorities will strive for the development of enterprises to provide more help and services, promote healthy and sustainable development.
China s medical device regulatory history is not long, in recent years, regulatory capacity and level has been improved significantly. Contrast in the past, or even with the enormous changes. Medical device regulatory laws and regulations, technical support system, detection system, adverse event monitoring system have gradually established and perfected, the unification of the national registration and approval of medical devices, production and management supervision, adverse event monitoring. “Continue to reinforce the regulatory basis of public safety with effective mechanical protection.” Edge vibration A historical review of China s medical device regulation, said.
For businesses concerned about the more ultra-approval time, grasp around the inconsistencies in the approval of the standard problems, while a vibration that, SFDA attaches great importance to the views of business, make great efforts to improve capacity and efficiency review. This year, compiled by the Office agrees, SFDA equipment review center staffing from 30 to 100; in order to improve the efficiency review, review center also conducted within the institutional reform. Through these efforts, review of equipment over time the problem has been basically solved.
Review in order to regulate behavior, uniform review of scale to help businesses research and reporting, review of regulatory authorities also actively developing technical specifications. Lu Aili, deputy director of Beijing Municipal Food and Drug Administration, said the Beijing bureau in the country since 2005 to develop and publish the first review of technical specifications, so far has publicly released the 30 specifications, covering about 50% of the species, ” where there are norms have accelerated the speed of review. ”
A side vibration that “five-second” period, both the medical device industry or medical device regulation, will usher in a new leap forward. SFDA supervision in the medical device further improve laws and regulations, improve standards, strengthen supervision, scientific monitoring and research into a reasonable state Bureau, Provincial Bureau, Council s powers to improve the efficiency of supervision. At the same time, doing service work for the industry to create a healthy and sustainable environment. I believe the next five years, government and industry through the joint efforts of the medical device industry will usher in more development opportunities, to be developed faster.