The safety and effectiveness of medical devices is directly related to human health and safety of life. 31, the newly revised "supervision and management of medical devices regulations" promulgated by the State Food and Drug Administration and the State Council Legislative Affairs Office of the person in charge of the regulations and relevant experts on the interpretation of the regulations.
Broad and strict difference: high-risk products "pressure" low-risk products "loose"
China's medical devices are many types, spanning a wide range of small tongue depressors, masks, large to the magnetic **** vibration instruments and other types of diagnostic equipment, various products have great differences in risk. The risk of various products vary greatly, both implantable devices that directly affect life safety, but also auxiliary devices that do not have a direct impact on physical health.
"These characteristics of medical devices determine both the implementation of strict management, but not 'one size fits all'." The State Council Legislative Affairs Office of UNESCO and Health Division Director Wang Zhenjiang introduced the current medical device regulatory regulations classification and management system is not perfect, some measures do not reflect the differences in the classification, the supervision of high-risk products is not enough for some low-risk product regulation should be liberalized not liberalized, the burden on enterprises is heavier.
Wang Zhenjiang said, in response to this problem, the newly revised regulations clearly stipulate that the medical devices in accordance with the degree of risk of implementation of classification management, according to the risk from low to high medical devices are divided into one, two, three, and according to the production and operation of medical equipment use of the product classification catalog in a timely manner to make dynamic adjustments, and the requirements of the development of adjustments to the directory to be fully listened to the views of all parties, with reference to the international medical device classification practice. International medical device classification practice. At the same time improve the classification of regulatory measures, follow the principle of leniency and strict differentiation, focusing on the supervision of high-risk products.
In terms of product management, it is clear that Class I medical devices are subject to product record management, Class II is subject to product registration management by provincial food and drug regulatory authorities, and Class III is subject to product registration management by the State General Administration of Quality Supervision. In terms of operation, liberalized the operation of the first class of medical devices, neither need to obtain a license, nor the implementation of the record. The operation of the second class of medical devices to implement record management, the operation of the third class of medical devices to implement licensing management.
The whole process of governance: to strengthen the "during" "after" supervision
Hu Yinglian, associate professor at the National School of Administration, believes that the regulations further simplify and decentralize the approval of the production and operation of medical devices. But before the license is reduced, and after the incident, the supervision and follow up is particularly important.
"In the past, there was a certain degree of 'heavy product approval, light process supervision' in the supervision of medical devices." Jiao Hong, director of food and drug safety at the Food and Drug Administration, said that in order to form a seamless regulatory system for the whole process, the new regulations will unify the four links of development, production, operation and use of medical devices into the scope of supervision by standardizing the licensing, adding the quality management standard for the production of medical devices as well as the reevaluation of registered medical devices, recall of medical devices and other systems, and reinforcing the sales records of the purchase and inspection of operating companies and the maintenance and use of the units. The use of units of repair and maintenance, the use of records and other obligations, basically formed a tight, full-chain regulatory system.
The new regulations, specifically set up "adverse events and the recall of medical devices" chapter, clearly put forward the establishment of medical device adverse event monitoring, re-evaluation, recall and other post-market regulatory system. Medical device adverse event monitoring, re-evaluation, recall and medical device production, operation, use of quality management system, supervision and sampling test and other regulatory means, *** with the formation of a more comprehensive, with international medical device regulatory standards of the product post-market regulatory system, the formation of the product before the market, the post-market regulatory linkage, to achieve the supervision of the whole life cycle of medical devices.
"Reward and punishment": encourage scientific research and innovation, punish illegal behavior
Currently, China's medical device industry is still facing problems such as the overall scale of the industry is relatively small, and the industrial base is relatively weak. China's medical device industry association president Zhao Yixin frankly: China's medical device industry enterprise individual scale is small, the United States largest 40 medical device output value accounted for 20% of the global medical device industry output value, while China has about 1.6 million manufacturers, but the output value of the global medical device industry accounted for only about 5%, and some companies violate the law also occur from time to time.
The general provisions of the regulations clearly state that the state encourages medical device research and innovation, promotes the promotion and application of new medical device technologies, and promotes the development of the medical device industry. The regulations also provide a series of specific system designs from the perspectives of optimizing review and approval, reducing the burden on enterprises, and encouraging innovation, which provide a strong legal basis and policy foundation for promoting the development of the medical device industry and encouraging enterprises to become bigger and stronger.
In order to regulate the behavior of the industry and promote the healthy development of the medical device industry, the new regulations encourage innovation while refining the legal responsibility, adjusting the range of penalties, increasing the types of penalties, and avoiding enforcement gaps.
Mao Zhenbin, director of the Food and Drug Administration Inspection Bureau, introduced the original regulations on serious violations of the general and impose a fine of 2 times to 5 times, and the new regulations and impose a fine of 5 times to 10 times, or even 10 times to 20 times the fine, substantially increasing the cost of violation of the law, the deterrent effect is significantly enhanced. In the investigation and handling of counterfeiting, forgery, trading, leasing, lending of medical equipment licenses related to illegal cases, the perpetrators of the implementation of administrative penalties, but not a crime and violated the law of public security management penalties, the new regulations clearly stipulate that the public security organs of the public security penalties to fill the gap between the criminal penalties and administrative penalties, do not give criminals the opportunity to take advantage of, but also strengthened the joint departmental law enforcement of the fight against the synergies. The new regulations also strengthen the joint law enforcement efforts of the departments to combat the problem.