The New Revised Regulations Issued The Era Of Full Life Cycle Supervision Of Medical Devices

Editor's note

In the process of fighting against the new crown epidemic, the shortcomings of the emergency approval system of medical devices in China have been exposed, and the "neck sticking" problem in China's medical device industry has also been magnified.

To build a "healthy China" in an all-round way, China's medical device industry must be bigger and stronger, and achieve high-quality development in the process of transformation and upgrading.

The newly revised "Regulations on the supervision and administration of medical devices" will provide a comprehensive legal guarantee for the innovation and high-quality development of medical devices in China from the top-level system design. From the system level, promote innovation, protect innovation, stimulate market vitality, and meet the people's demand for high-quality medical devices.

Recently, the State Food and Drug Administration officially issued the revised "Regulations on the supervision and administration of medical devices" (hereinafter referred to as the "Regulations"), which was promulgated on January 4, 2000 and revised for the first time in February 2014. The revised version was revised and adopted at the 119th executive meeting of the State Council on December 21, 2020. The revision of the regulation includes encouraging innovation, simplifying the process, encouraging clinical trials, and monitoring the whole life cycle of medical devices.

"In addition to disposable products, the whole cycle of the use, repair and maintenance of medical devices should be included in the scope of supervision, which is also determined by the characteristics of medical devices." On March 22, Wang Baoting, Deputy Secretary General of China drug regulatory Research Association, who participated in the preliminary discussion on the formulation of regulations on the supervision and administration of medical devices, said in an interview with the 21st century economic news reporter that the amendment of the regulations also provides a basis for subsequent law enforcement, increases the degree of punishment, increases the cost of violation of laws, and punishes individuals for violation of laws, so as to better promote the development of industry norms.

Xu Jinghe, deputy director of the State Drug Administration, recently published an article to interpret the regulations and stressed the importance of supervision. The previous regulations on the supervision and administration of medical devices (Revised Draft) emphasized the strengthening of the responsibility of enterprises and research institutions for the safety and effectiveness of medical devices, clarifying the approval and filing procedures, enriching the regulatory means, and adding the unique product identification Supervision measures such as retroactive and extended inspection should be taken to strengthen the punishment of illegal acts. The amount of fine for serious violations involving quality and safety should be greatly increased. The units and persons responsible for serious violations should be given severe penalties such as revoking their licenses and banning the entry of industries and markets. Those involved in crimes should be investigated for criminal responsibility according to law.

Chi Hui, director of the Institute of medical information of the Chinese Academy of Medical Sciences and vice president and Secretary General of the Chinese society of Biomedical Engineering, said that the revised regulations, on the whole, implemented the reform requirements of the review and approval system of pharmaceutical and medical devices, released the vitality of market innovation, strengthened supervision, and took into account the response to public health emergencies, which was more in line with the actual needs.

Support innovative clinical promotion and use of medical devices, and promote high-quality development of medical device industry. Xinhua News Agency

Encourage innovation and enhance industry concentration

The regulation has been adjusted from various angles, among which the most updated trend guidance is to encourage innovation, and many regulations encourage the innovation and development of medical devices.

For example, in the general introduction of Chapter I, the newly added four items are all set up to encourage the innovation and development of medical devices. Among them, Articles 8 and 9 make it clear that the innovation of medical devices is the key point of development, and the policies release a strong signal to encourage the innovation of medical devices, which is a great benefit to the innovative products of medical devices.

Among them, Article 8 emphasizes that the State shall formulate medical device industrial planning and policies, incorporate medical device innovation into the development focus, give priority to the review and approval of innovative medical device, support the clinical promotion and use of innovative medical device, and promote the high-quality development of medical device industry. The drug regulatory department under the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and guidance policy.

Article 9 proposes that the state should improve the innovation system of medical devices, support the basic research and Application Research of medical devices, promote the promotion and application of new technologies of medical devices, and provide support in scientific and technological projects, financing, credit, bidding procurement, medical insurance, etc. Support enterprises to establish or jointly establish research and development institutions, encourage enterprises to cooperate with universities, scientific research institutes and medical institutions to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the independent innovation ability of medical devices.

Article 12 it is proposed that units and individuals who have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with the relevant provisions of the state.

Article 8 specifies that the drug administration should cooperate with other departments of the State Council to implement the national medical device industry planning and guidance policy. This new regulation allows us to foresee that in the future, the FDA will introduce more policies to accelerate the review and approval in promoting and encouraging the innovation of medical devices.

In this regard, a person in charge of a medical device enterprise in Wuxi Industrial Park told the 21st century economic reporter that the state has been encouraging innovation in recent years, and this "regulation" is also a continuation of previous policies, which is good for innovative enterprises and will greatly accelerate the speed of new products entering the market.

Zhongtai Securities pointed out that the implementation of the new regulations is of great significance to the development of innovative medical devices, which is conducive to stimulate the continuous innovation of small and medium-sized medical device enterprises, shorten the product listing cycle, reduce the R & D and production costs, optimize the allocation of resources and enhance the competitiveness of large-scale device companies. It is also conducive to improving the industry concentration, eliminating "low, small and scattered", and promoting the adjustment of industrial structure. After the implementation of the registrant system, the small and medium-sized enterprises with serious homogeneity of R & D pipelines and low product quality will be phased out, the backward production capacity will be further reduced and the industry concentration will be further improved.

Wang Baoting analyzed to the 21st century economic reporter that in the past, the registered person must have a production enterprise, including plant, equipment, system, personnel, testing, etc., but in the future, the registered person is not required to have a production system, and the registered person can entrust others to produce for him.

"At present, there are too many small and medium-sized medical device manufacturing enterprises in China, and the production capacity is surplus. Commissioned OEM is conducive to the expansion and concentration of production scale of production enterprises, which can effectively reduce costs and control production quality. Therefore, the registration system has been introduced." Wang Baoting pointed out.

At present, domestic medical device enterprises are "many, small and scattered", and the industry concentration is low. At the same time, as the main force of innovation in the medical device industry, the proportion of high-tech enterprises in China is relatively low, and 90% of China's medical device industry is small and medium-sized enterprises, the technology content is relatively low, and the product structure needs further adjustment.

According to the statistics of Zhongcheng medical equipment big data platform, by the end of December 2020, there were 25440 medical device manufacturers in China, including only 5588 high-tech enterprises, accounting for 22.0% of the total. In terms of product structure, 15924 enterprises can produce class I products, 13813 class II products and 2202 class III products.

Secondly, domestic medical device enterprises have less R & D investment, low innovation ability and lack of core competitiveness, which leads to a high proportion of medium and low-end products and foreign monopoly of high-end products.

New era of life cycle regulation

The regulations clearly put forward that the supervision and management of medical devices should follow the principle of scientific supervision.

It is understood that the State Food and drug administration has launched the drug regulatory science action plan in 2019, relying on domestic well-known universities and scientific research institutions to establish a number of regulatory science research bases, make full use of social forces, and research innovative tools, standards and methods to solve the problems and challenges in the supervision work in the new era and under the new situation, so as to enhance the scientificity, foresight and adaptability of the supervision work Response.

It is worth noting that the regulations strengthen the supervision of the whole life cycle and the whole process of medical devices, implement the system of medical device registrants and recorders, and strengthen the main responsibility of enterprises. It is stipulated that the registrant and the record holder shall establish and effectively operate the quality management system, strengthen the post marketing management of the products, establish and implement the product traceability and recall system, and be responsible for the safety and effectiveness of the whole process of the development, production, operation and use of medical devices according to law.

In the chapter of registration and filing of the regulations, it is worth noting that the newly added 20 articles emphasize that enterprises should strengthen post listing supervision. The following obligations shall be fulfilled by the registrants and recorders of medical devices, including: (1) establishing a quality management system suitable for the product and maintaining its effective operation; (2) formulating post marketing research and risk control plans and ensuring their effective implementation; (3) carrying out adverse event monitoring and re evaluation according to law; (4) establishing and implementing product traceability and recall system; (5) establishing and implementing product traceability and recall system ）Other obligations prescribed by the drug regulatory department under the State Council. The domestic enterprise legal person designated by the overseas medical device registrant or the record holder shall assist the registrant and the recorder to fulfill the obligations specified in the preceding paragraph.

Wang Baoting believes that the medical device enterprises are not the end point after their products are sold. At present, they are required to carry out the whole life cycle supervision on the products. That is, after the products are sold, the sellers still need to be responsible for the follow-up quality of the products, be responsible for the maintenance and ensure their normal operation. "The whole life cycle management should be continued until the equipment disposal stage, and its file management should be kept for 5 years after scrapping."

The legal liability provisions of the regulations have also been revised, including a substantial increase in the range of fines, especially for illegal acts involving quality and safety, which can be fined up to 30 times of the value of goods; and the punishment of banning entry into the industry and market has been increased; at the same time, the "punishment to people" provision has also been added.

In the 2014 version of the regulations, the legal representative, the main person in charge, the directly responsible person in charge and other responsible personnel of a serious illegal unit shall be confiscated of the income obtained from the unit during the period of the illegal act, and a maximum fine of three times may be imposed, and the relevant activities shall be prohibited for five years or even for life.

The cost of illegal activities under the new regulations is much higher than that in the 2014 edition.

In the new regulations, if the value of illegal production and operation of medical devices is less than 10000 yuan, a fine of more than 50000 yuan and less than 150000 yuan shall be imposed; if the value of goods is more than 10000 yuan, a fine of 15 times to 30 times of the value shall be imposed; if the circumstances are serious, it shall be ordered to stop production and business, and shall not accept the medical device license application from the relevant responsible person and the unit within 10 years The designated representative, the principal person in charge, the directly responsible person in charge and other responsible persons shall confiscate the income obtained from the unit during the period of the illegal act, and shall be fined 30% to 3 times of the income obtained, and shall be prohibited from engaging in the production and operation of medical devices for life.

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