Innovation is the inexhaustible driving force for the development and progress of countries and nations. The process of modern world development shows that major original scientific and technological innovation and the industrial technology revolution it triggers often lead to epoch-making changes in human life and social outlook. Countries with strong scientific and technological innovation capabilities have become the dominant players in the world's scientific and technological, economic, cultural and social development.
As an industrial field closely related to public health and life safety, medical devices cover a wide range of products, including tongue depressors, gauze and other low-value consumable products, as well as high-tech and high-priced equipment such as multi-row CT, PET-CT, superconducting magnetic **** vibration, proton gas pedal. At present, China's conventional medical devices have basically realized independent production, high-end medical devices have also been involved, but the situation dominated by low-tech content, low-tech level of low- and medium-grade products has not changed. As of 2013, the country **** has nearly 16,000 medical device manufacturers, of which the third class medical device manufacturers accounted for about 17%, the second class medical device manufacturers accounted for about 54%, the first class medical device manufacturers accounted for about 29%. This shows that China's medical device industry, the production of high technology content of the third class of medical devices in the enterprise is relatively small, the innovation ability needs to be improved.
The newly revised Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as "the Regulations") will come into force on June 1, 2014. 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 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.
Under the current model of "production license first, product registration later", after obtaining the license to manufacture medical devices, the manufacturer should also obtain the product registration certificate for the production and operation of medical devices.
The newly revised Regulations further simplify and decentralize the approval of the production and operation of medical devices, according to the degree of risk of medical devices, the production and operation of activities to implement classification management.
The Regulations also pay special attention to the positive role of industry organizations in ensuring the safety and effectiveness of medical devices and promoting the development of the medical device industry, requiring that the medical device industry organizations should strengthen industry self-discipline, promote the construction of integrity system, and guide the enterprises to be honest and trustworthy; and explicitly stipulates that the State Council's food and drug supervision and management departments to develop, adjust and modify the directory of the provisions of the Regulations as well as norms related to the supervision and management of medical devices should solicit the public's views and comments. Supervision and management of norms related to medical devices, should be open for comments, listen to experts, medical device production and management enterprises and use of units, consumers and related organizations and other aspects of the views
China's "National Economic and Social Development Twelfth Five-Year Plan Outline" clearly puts forward the need to strengthen the technological transformation of enterprises, accelerate the application of new technologies, new materials, new technology, new equipment to transform and upgrade the traditional industries and improve the market competitiveness, encouraging enterprises to enhance their new product development capabilities, improve the technological content and added value of products, and accelerate product upgrading. With the progress of science and technology and the improvement of public living standards, new medical devices based on new principles, with new functions, superior performance, safer and more effective diagnosis and treatment continue to emerge, computer technology, microelectronics technology, finishing technology, intelligent technology and other new scientific and technological means are applied to the design and development of medical devices. Influenced by natural and social factors, China's population continues to grow and aging is becoming more and more prominent; at the same time, in order to promote the integration of urban and rural development, the country is vigorously promoting urbanization, which provides a huge market demand for medical device products and a broad prospect for the development of medical device industry. The birth, development and application of new technology can not be separated from the support and protection of the system, just at this time, the "Regulations" was introduced, which about the enterprise to reduce pressure to loosen, encourage innovation provisions for the regulatory authorities to develop to support the innovation of medical devices and the actual steps taken to provide the basis for the supra-legal law, the upgrading of the medical device industry will play a strong role in guiding and promoting the role of the upgrading of the medical device industry. Recently, the State Council revised and issued the "Regulations on the Supervision and Administration of Medical Devices", based on classification management, highlighting the scientific nature of risk management, rationally designing and improving the review and approval mechanism, further standardizing the pre-market filing and licensing system of medical devices, reflecting the spirit of the Third Plenary Session of the 18th CPC Central Committee, which proposes to "set up the strictest supervision and regulatory system covering the whole process". "
It is the first time that a medical device has been approved for use in the market.
I. Scientific design of medical device classification and management system
Medical devices are categorized into Class I, II and III according to their risk level, and Class III products are the highest risk products. Regulations throughout the medical device risk management concept, the classification of medical devices is more detailed, rigorous, clear and more operable.
Second, to further clarify the division of authority between the central and local
Medical device registration is the food and drug supervision and management department according to the application of the applicant for registration of medical devices, in accordance with the statutory procedures, the proposed sale of medical devices to be marketed for the safety, efficacy, quality of controllability of the research and its results of the implementation of the systematic evaluation, in order to decide whether to agree with the approval of its application process.
The State Food and Drug Administration (SFDA) is also responsible for formulating classification rules and classification catalogs of medical devices as well as catalogs of medical devices exempted from clinical trials; and working with the competent department of health and family planning under the State Council to formulate, adjust, and publicize the catalogs of single-use medical devices.
Three, strengthen the medical device review and approval system reform
"Regulations" on medical device review and approval system is more scientific and reasonable.
Technical review of medical devices is an important technical support for registration management. At the same time, accelerate the construction of medical device registration management information technology, strengthen the medical device registration, filing information disclosure, under the premise of playing a leading role in the government, to encourage and support the participation of all aspects of society, give full play to the role of social organizations and medical device industry associations, to participate in the registration and management of medical devices, expanding regulatory resources. The newly revised Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as the "Regulations") will come into force on June 1, 2014," the company said.
First, the implementation of medical device adverse event monitoring system is conducive to early warning and prevention of product risk. With China's economic and social development and people's living standards, health awareness, the public demand for device safety is increasingly high, medical device manufacturers, operators and users of product safety, effectiveness need to strengthen the monitoring of food and drug regulatory authorities need to continuously improve the monitoring and evaluation of adverse events of medical devices work capacity, through the collection and evaluation of adverse event reports, to extract the risk signals, to detect and timely control the risks of post-marketing medical device products and eliminate hidden dangers. Strengthening the monitoring of adverse events of medical devices can not only provide regulatory basis for the food and drug regulatory authorities to take necessary measures to reduce or avoid the recurrence of similar adverse events, reduce the risk of patients, medical personnel and other personnel using medical devices, to protect the general public with the safety of medical devices; but also strongly promote the improvement and upgrading of the products of enterprises, promote the research and development of new products, which is conducive to promoting the healthy development of China's medical device industry.
It is also possible to promote the improvement and upgrading of products and the research and development of new products, which is conducive to the healthy development of China's medical device industry.
The second is to carry out medical device re-evaluation, is conducive to the control of medical device products after the market risk. The re-evaluation of medical devices is an important part of the post-market supervision of medical device products, and is an important part of ensuring the safety of public use of medical devices. The re-evaluation of higher risk products after listing is actually a re-evaluation of the safety and effectiveness of such products.
Third, the establishment of medical device recall system, is conducive to protect the public safety of equipment. The recall system is established for defective products that have entered the market. Because defective products are often characterized by bulk, when these products are put on the market, if not intervened, its potential harm is very large, may cause damage to the lives of consumers, property safety or the environment, the community and the public security risks. The safety and effectiveness of medical devices are directly related to people's health and life safety. The newly revised Regulations for the Supervision and Administration of Medical Devices have been promulgated and will come into force on June 1, 2014, which is a major event in the modernization process of China's medical device supervision.
I. Enhancement of Medical Device Risk Management Capability
Regulatory modernization is an important part of national governance modernization. Risk governance is the road to regulatory modernization. The new "Regulations" from the source of governance, systematic governance and governance in accordance with the law in three aspects, to enhance the medical device risk governance capacity.
(I) Governance at the source, coordinating the relationship between regulation and development.
(ii) system governance, rational allocation of horizontal and vertical regulatory power. To cope with systemic and global risks, it is necessary to rationally allocate horizontal and vertical regulatory powers. Second, the vertical scientific allocation of regulatory resources. The division of powers between the central and local authorities depends mainly on the trade-off between the external costs of their spillovers and the internal benefits of localization. By adjusting the approval and filing authority, the new Regulations give full play to the advantage of localities in grasping the actual information on the basis of emphasizing the unified authoritative regulator. In the registration link, the approval of Class I medical devices is changed from local municipal bureaus to filing, and the approval of Class II and Class III medical devices is retained to be approved by provincial bureaus and the State General Administration of China respectively. Production link, from a class of medical device manufacturers to the provincial bureau for the record, two, three by the provincial bureau for approval, to a class to the local municipal bureau for the record, retaining two, three by the provincial bureau for approval. Business link, from a class of medical equipment business enterprises to the provincial bureau for the record, two, three types of approval by the provincial bureau, to a class without filing or approval, two types of filing by the local municipal bureau, three types of approval by the local municipal bureau.
(C) the rule of law, the establishment of the most stringent regulatory system. The rule of law is the core of regulatory modernization, to strictly abide by the regulations and standards, with the most stringent supervision, the most severe penalties, the most serious accountability, to ensure the safety and effectiveness of medical devices, and revoke the agency's qualifications and included in the "blacklist", 10 years do not accept applications for accreditation; dismissed from the direct responsibility of the staff, the provisions of the 10 years May not be engaged in medical device inspection work.
Two, decentralization without forgetting the "put", "management" combination
The government and the market is to stimulate economic vitality of the two basic elements. To create an "upgraded version" of China's economy, a new breakthrough in product quality is needed.
(I) Improve the scientific nature of the classification and management system. Medical devices are varied, spanning a wide range of complex business, from large nuclear magnetic **** vibration apparatus, as small as tongue depressor, there are differences in risk.
(ii) appropriately reduce the prior administrative approval. Reduce the government's undue interference in the operation of the market, the market and society can do as much as possible to put out, put in place, to stimulate the vitality of various types of market players. The current "Regulations" provides for 16 administrative licenses, the new "Regulations" not only did not add new licenses, and combined with the successive administrative licensing clean-up, **** reduced 7 licenses.
(C) focus on strengthening the supervision and management of the incident. The more the reduction of pre-permission, the more the supervision of the aftermath of the incident to keep up with the government to manage the matters effectively managed, management in place.
Three, innovative social **** governance pattern
(a) so that manufacturers and operators really become the first responsible for the safety of medical devices. The new "Regulations" to play a leading role in the government's premise, emphasizing the role of the main responsibility of enterprises.
(ii) mobilizing the enthusiasm of social subjects to supervise.The 2013 State Council Institutional Reform and Functional Transformation Program emphasizes the need to give full play to the role of market mechanism, industry self-regulation and social supervision in food and drug supervision. The new Regulations stipulate that medical device industry organizations should strengthen industry self-discipline and guide enterprises to be honest and trustworthy; add a complaint reporting system and reward substantiated reports as a way to stimulate the whole society to participate in **** governance.
(C) to information technology as the focus of the regulatory model innovation. Informatization is an important tool for modern regulators, and is usually more efficient than hard controls. The new Regulations provide for the establishment of a unified national medical device regulatory information platform, the food and drug regulatory authorities through the platform in accordance with the law and timely publication of medical device licensing, filing, sampling and testing, investigation and handling of violations of law and other information. Regulatory information from the government to open and transparent, can force enterprises to cherish the reputation, improve the quality management level; but also to help consumers identify the advantages and disadvantages of the product, to promote healthy market competition. More importantly, the innovation of the regulatory model focusing on information technology represents the future direction of regulatory development.