At 14:30 on April 4, 2014, Xu Jinghe, director of the Department of Legal Affairs of the Food and Drug Administration, Tong Min, director of the Department of Medical Devices Supervision and Gao Guobiao, deputy director of the Department of Medical Devices Registration, were interviewed by the Chinese government online to interpret the netizen's questions about the Regulations on Supervision and Administration of Medical Devices.
Question 1: Why is this revision of the Regulations taking place? This is also the first time in 14 years to comprehensively modify, modify the main ideas and modify the focus is what?
Xu Jinghe replied: good afternoon, everyone. Medical devices are one of the five major health products that the food and drug regulatory authorities are responsible for regulating, and it is a matter of public health and life safety.
As we all know, the Regulations were originally issued in 2000 and implemented on April 1, 2000. Now the "Regulations" has been implemented for about 14 years, objectively speaking, the "Regulations" for the standardization of medical equipment development, production, operation, use of activities, strengthen the supervision and management of medical devices, improve the quality and safety of medical devices in our country has played a very important role. Since entering the new century, China's medical device industry has been developing rapidly, the consumption level of medical devices has been rapidly increased, the supervision of medical devices has been increasing, the implementation of the "Regulations" in the process of the implementation of some of the problems do not adapt to the new situation, the need to amend the "Regulations". Specifically, the Regulations are not adapted to the main four aspects, can be summarized as "four insufficient": First, the classification and management system is not perfect. We know that medical device varieties are very many, the chain is long, spanning a large, some of the existing "Regulations" regulatory measures in the embodiment of the classification of the difference is not sufficient, for some high-risk products are not enough to regulate, for some low-risk products should be said to release the release has not been completely liberalized, at the same time, in the development of medical devices, production, operation, the use of the whole process of the classification of the system of supervision is not thoroughly implemented. Secondly, the main responsibility of medical device enterprises is not specific enough. The original "Regulations" in the main responsibility of enterprises have some provisions, but not comprehensive enough, not specific enough, especially the enterprise as the first responsibility of the requirements need to be further clarified. Third, the input of regulatory power is not balanced enough. To a certain extent, there is a focus on product approval, light process supervision. Fourth, the legal responsibility is not enough to adapt to the provisions. Some provisions are not specific enough, especially in recent years, the emergence of a number of violations of the law, the lack of effective and sufficient basis for combating punishment and strength.
Since the 18th National Congress, the CPC Central Committee and the State Council to strengthen food and drug supervision and management work put forward a lot of new ideas, new requirements, in the revision process, the State Food and Drug Administration and the Legislative Affairs Office of the State Council to conscientiously implement the requirements of the central government to ensure that the safety and effectiveness of medical devices to ensure that the public's health and safety of life for the purpose of the legislation, risk management as an important basis for the design of the system, in the overall thinking of the following four main grasp of the main provisions of the law. In the overall idea to grasp the following four aspects: First, according to the degree of risk to implement classification management, and thus to determine the medical device development, production, operation, use of each link of the system, to further strengthen the scientific nature of supervision. Secondly, based on the risk level, under the premise of ensuring the safety and effectiveness of the products, insisting on the combination of management and release, leniency and strictness, putting pressure on the manufacturers of high-risk products and loosening the restrictions on the manufacturers of low-risk products, and promoting the medical device manufacturers to become bigger and stronger. Third, follow the spirit and requirements of promoting the transformation of government functions and deepening the reform of the administrative approval system, appropriately reduce the prior authorization, focusing on strengthening the process of supervision and daily supervision, and improve the effectiveness of supervision. Fourth, to encourage the community to participate in the supervision of medical devices, the formation of a good social **** governance pattern.
The new regulations are 8 chapters and 80 articles, compared with the original regulations increased by 2 chapters and 32 articles, the magnitude of the modification is still relatively large. The main content of the modification can include the following aspects: the first aspect, improve the classification and management system. First of all, in the "General Principles" part of the establishment of the classification of medical devices management of such a basic principle, where as the basic principle, that is, this principle should be throughout the entire process of medical device production, operation and all aspects. Regulations" in Article 4 clearly stipulates that the state of medical devices in accordance with the degree of risk to implement the classification and management, according to the risk from low to high is divided into a class, class II, class III, and at the same time improve the classification of the specific measures for supervision and control, follow the principle of strict and lenient, focusing on the supervision of high-risk products, such as in the registration of the product, the clear first class of medical device products for the record, the second by the provincial implementation of the registration and management, the third by the national registration management. The third class by the national registration management.
In terms of production management, the first class by the municipal level for the record, the second class, the third class to the provincial food and drug regulatory departments to apply for permission. In terms of business, the liberalization of the first class licensing business, neither permit, nor record. Engaged in the second class of medical devices, should be filed to the municipal level, the third class should be licensed management. The second aspect, the appropriate reduction of prior authorization. The original regulations provide for 16 administrative licenses, this time not only no new licenses, and combined with the successive administrative licenses, clean-up, *** minus 7 licenses, now there are 9 licenses left. Reduce 7 is 331, canceled 3, transformed 3, reduced 1. The third aspect is to increase the responsibility of production and management enterprises and use units. First, increase the production and operation of enterprises in the product control responsibility, such as the production of enterprises should establish a medical device management system, at the same time to ensure the effective operation of the entire system, to regularly submit self-inspection reports to the regulatory authorities, so that the entire system can be in the dynamics of reflecting the level of its management. Second, the establishment of business and use of the purchase inspection and sales record system. Requirements for the operation of enterprises and the use of units to check its supply qualifications and product documentation, and records. Third, it is clear that the use of medical equipment management obligations. It should be said that this and the original regulations in the past compared with a lot of progress, the new regulations have eight provisions to strengthen the use of medical equipment units of medical equipment management obligations. Fourth, innovative regulatory means to strengthen the daily supervision. First, improve the relevant management system, improve some management tools, for example, the new "Regulations" increased the monitoring system of medical device adverse events, and the re-evaluation system of registered medical devices, medical device recall system. Secondly, it strengthens the responsibility of daily supervision. It is clear that the supervisory authorities should focus on the inspection of whether the manufacturer organizes the production in accordance with the technical requirements of the registered or filed products, whether the quality management system of the manufacturer maintains effective operation, and whether the production and operation conditions continue to meet the statutory requirements. Third, regulate the extension of registration, sampling and other regulatory actions, the new "Regulations" provides that in addition to the three non-extension of the registration of the statutory circumstances, the regulatory authorities should be granted an extension of registration, and sampling shall not be charged any fees, commissioned the inspection should pay the relevant inspection costs. Fifth, improve the relevant legal responsibility. Legal responsibility is also a new "Regulations" a big highlight. First, the penalties have been refined to enhance the operability. Corresponding to the obligations set out in the chapter, in accordance with the part of the legal responsibility of the severity of the violation of the establishment of the legal responsibility of the sub-article. The second is to adjust the penalty, increase some types of punishment, can be said to increase the investigation and punishment of illegal behavior. For example, the unauthorized production and operation of medical devices, the maximum fine of 20 times the amount of the value of goods. Now the new medical device supervision and management regulations will be implemented on June 1, now the food and drug administration is doing a good job in the implementation of the preparatory work. First, to carry out publicity and training. Requirements for production and management enterprises, supervision and management departments to seriously study, fully understand and accurately grasp the spirit of the Regulations and the requirements. The second is to step up to improve the relevant supporting system. Because the implementation of the "Regulations" also need some supporting system support, we at the same time to the past has been promulgated regulations and normative documents to clean up, to ensure the consistency of the implementation of the legal system of medical devices.
Question 2: What are the adjustments in the new "Regulations" on the production of medical devices regulatory model?
Tong Min replied: Good afternoon, everyone. On the one hand, the new "Regulations" is mainly in the medical device product registration and production licensing of the convergence of major adjustments. The old "Regulations" used "first production license, after product registration" mode, although in the protection of product quality has played a positive role, but the production enterprises in the production license to complete the process of product registration, easy to cause the enterprise personnel, space and equipment idle, increasing the burden on the enterprise. Some scientific research institutions are unable to obtain the production license, which limits the enthusiasm of their innovative research on medical devices. The new Regulations clarify the regulatory model of "product registration and production license" for medical devices, and stipulate that the manufacturer can apply for the production license of medical devices under the condition of the product registration certificate of medical devices. This change in the regulatory model, both to further encourage innovation, but also to reduce the enterprise in the product to get registered before the investment of people and materials. Secondly, it reflects the requirement of further decentralization. The new "Regulations" to follow the measures and requirements to promote the transformation of government functions, risk management as the core, to further implement the adjustment of government functions and decentralization requirements. The new "Regulations" will be the production of Class I medical devices, from the original to the location of the provincial food and drug regulatory departments for the record, to the location of the municipal food and drug regulatory departments for the record. At the same time, the new "Regulations" will be domestic first-class medical device product registration to the municipal food and drug regulatory departments for the record, so as to achieve the medical device product record and production record the unity of the regulatory body, so that the regulatory powers and responsibilities are clearer.