The new version of the "Regulations on the Supervision and Administration of Medical Devices" has been announced, with the registrant system becoming the main line of the new regulatory system.

The new version of the "Regulations on the Supervision and Administration of Medical Devices" has been announced, with the registrant system becoming the main line of the new regulatory system.

Preventing companies that violate regulations from establishing themselves.

● Recently, the revised "Regulations on the Supervision and Administration of Medical Devices" were announced and will officially take effect from June 1, 2021.

● Registrants and filers should establish and effectively operate a quality management system, strengthen post-market management, establish and implement product traceability and recall systems, and legally assume responsibility for the safety and effectiveness throughout the entire process of research, production, operation, and use of medical devices.

● Implementing industry and market entry bans on seriously violating companies is beneficial for ensuring that companies adhere to the "bottom line" of medical device quality and safety, creating a strong deterrent against serious violations, maintaining a high-pressure situation, preventing companies that touch the "red line" of regulations from establishing themselves, and promoting healthy and compliant development of enterprises.

Medical devices are directly related to the life and health of the people. Recently, the revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") were announced and will officially take effect from June 1, 2021.

In recent years, with the rapid development of the medical device industry, the Party Central Committee and the State Council have made a series of major decisions and deployments regarding the reform of the review and approval system for drugs and medical devices. Against this background, the original "Regulations" have been revised accordingly to consolidate the reform achievements in the form of laws, which can further promote industry innovation at the institutional level and better meet the public's expectations for high-quality medical devices.

Regarding this revision, the industry believes that it is a milestone in the history of medical device regulation in China and the development of the Chinese medical enterprise industry, which will play an important role in promoting the rapid development of China's medical device industry. Among them, the registrant system is a major highlight of the new "Regulations" and the main line of the new regulatory system.

Strengthen the main responsibility of enterprises and establish a traceability and recall system.

As of the end of 2020, there were about 26,000 medical device manufacturing enterprises in China, with approximately 15,000 producing Class I medical devices, 13,000 producing Class II medical devices, and 2,000 producing Class III medical devices. The total number of registered and filed medical device enterprises is 890,000. The scale of domestic medical device production and sales is growing at an annual rate of about 20%, while the global growth rate is 5% to 6%, indicating that the growth rate of the domestic medical device market significantly exceeds the global increase.

In recent years, with the joint promotion of regulatory policies from various aspects of the state, many categories of domestic medical devices have flourished and achieved import substitution. However, the problems cannot be ignored; currently, domestic medical device manufacturing enterprises also face a situation of being small and scattered, with an urgent need to enhance innovation capabilities.

To this end, the "Regulations" focus on implementing the registrant and filer system for medical devices in order to strengthen the main responsibility of enterprises. The "Regulations" stipulate that registrants and filers should establish and effectively operate a quality management system, strengthen post-market management, establish and implement product traceability and recall systems, and legally assume responsibility for the safety and effectiveness throughout the entire process of research, production, operation, and use of medical devices.

Yu Qingming, Secretary of the Party Committee of China National Pharmaceutical Group Corporation and a representative of the 13th National People's Congress, introduced that from an international perspective, the marketing authorization holder system (registrant system) is the prevailing management system in the fields of drugs and medical devices in today's international community, and it is a basic legal system that runs through the entire life cycle of drugs and medical devices. In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices," proposing to strengthen the management of the entire life cycle of medical devices and implement the marketing authorization holder system (medical device registrant system), and to hold the marketing authorization holder responsible for the quality and safety of the product throughout its life cycle.

Yu Qingming believes that the medical device registrant system will bring huge reform dividends, mainly reflected in three aspects: first, it is conducive to optimizing resource allocation, promoting industrial concentration, and enhancing competitiveness; second, it encourages innovation and shortens the product launch cycle; third, it promotes supply-side structural reform, eliminates "low, small, and scattered" enterprises, and helps adjust the industrial structure and achieve high-quality development.

Severely crack down on illegal activities and promote compliant development of enterprises.

Increasing the penalties for illegal activities and raising the cost of violations is a highlight of this revision of the "Regulations." The new version of the "Regulations" fully implements the requirements for drug safety's "four strictest" standards, while further clarifying the responsibilities of registrants, filers, manufacturing and operating enterprises, and users, detailing the circumstances of violations, increasing the penalties for illegal activities, and ensuring that penalties are imposed on responsible individuals.

The new version of the "Regulations" strictly enforces the provision of "penalties to individuals," imposing penalties not only on illegal units but also on the legal representatives, main responsible persons, directly responsible supervisors, and other responsible personnel of seriously violating units. Penalties include confiscating income obtained during the period of illegal activities, with fines up to three times the amount, and prohibiting them from engaging in medical device manufacturing and operating activities for five years or even for life.

Wang Baoting, Vice President of the China Pharmaceutical Supervision and Administration Research Association, believes that implementing a "double penalty system" targeting both enterprises and their responsible personnel makes the legal responsibilities of enterprises and their employees clearer, thereby compelling responsible personnel to truly fulfill their legal obligations and enhancing awareness of main responsibility and legal awareness.

The new version of the "Regulations" increases the penalties for industry and market entry bans based on the severity of violations. For serious violations or those causing severe consequences, it stipulates penalties such as ordering the suspension of production and business operations until the revocation of production and operation licenses, restricting applications for medical device licenses, and prohibiting engagement in related activities for a certain period. It further increases the scope of disqualification penalties. For example, for the production and operation of Class II and III medical devices without obtaining a medical device registration certificate, engaging in Class II and III medical device production activities without permission, and engaging in Class III medical device operation activities without permission, the period for which applications for medical device licenses from responsible individuals and enterprises will not be accepted has been extended from the original five years to ten years, and responsible personnel will be permanently prohibited from engaging in medical device manufacturing and operating activities; for providing false materials or using other deceptive means to obtain medical device registration certificates, production licenses, and other permits, the period has also been extended from five years to ten years, with permanent prohibition for responsible personnel.

In this regard, Wang Baoting believes that implementing industry and market entry bans on seriously violating enterprises is beneficial for ensuring that companies adhere to the "bottom line" of medical device quality and safety, creating a strong deterrent against serious violations, maintaining a high-pressure situation, preventing companies that touch the "red line" of regulations from establishing themselves, and promoting healthy and compliant development of enterprises.

The new version of the "Regulations" significantly increases the amount of fines for illegal activities. For the production and operation of medical devices that have not been registered and for engaging in medical device production and operation activities without permission, the fines have been raised from the original 10 to 20 times the value of the goods to 15 to 30 times; for failing to file as required and not correcting within the time limit, the fines have been raised from the original amount of less than 10,000 yuan to 5 to 20 times the value of the goods; and so on.

"Increasing penalties and severely cracking down on illegal activities in the research, production, operation, and use of medical devices further enhances the deterrent effect against illegal activities, improves the regulatory effectiveness of medical devices, protects the development environment and market order of the healthy medical device industry, and effectively ensures the safety of the public in using medical devices," said Wang Baoting.

Increase the frequency of supervision and inspection, and legally strengthen the punishment for dishonesty.

The medical device product categories are numerous and involve complex professional technical fields. To grow into a qualified medical device regulatory personnel, one needs to undergo systematic accumulation of professional knowledge, systematic training in inspection skills, and long-term practical experience accumulation. There are many medical device companies, and new business formats are constantly emerging. The supervision of medical devices after they are marketed faces many challenges, and there is an urgent need to build a professional and specialized team of inspectors to strengthen medical device inspection work and supervise enterprises to continuously comply with legal requirements.

In July 2019, the State Council issued the "Opinions on Establishing a Professional and Specialized Team of Drug Inspectors," requiring that by the end of 2020, the drug regulatory departments of the State Council and provincial drug regulatory departments basically complete the system construction of a professional and specialized team of inspectors. Currently, most provincial drug regulatory bureaus have established dispatched institutions based on the regulatory needs of their jurisdictions and have issued special documents for the construction of the inspector team. The construction of the medical device inspector team has already taken shape, but it still needs to be consolidated from the regulatory level.

Yang Yue, a researcher at Tsinghua University School of Pharmacy, analyzed that this regulation clarifies the legal status of the medical device inspector team from the regulatory level, which is beneficial for subsequently improving the professional qualifications, rights, obligations, responsibilities, entry and exit mechanisms, as well as evaluation and promotion of inspectors, further promoting the construction of a professional and specialized inspector team.

In addition, the new version of the "Regulations" fully absorbs the pilot experience of the medical device registrant system in relevant provinces across the country, allowing registrants to delegate tasks in the research, production, and sales distribution stages of medical devices, optimizing resource allocation and promoting the formation of new business formats in medical devices.

At the same time, the new version of the "Regulations" stipulates that drug regulatory departments establish credit files for medical device registrants, recorders, production and operation enterprises, and user units, increasing the frequency of supervision and inspection for those with bad credit records, and legally strengthening the punishment for dishonesty.

Yang Yue believes that the credit mechanism, paired with severe penalties, is an effective combination mechanism for promoting industry self-discipline. By building a credit-based regulatory mechanism through the construction of an enterprise credit system, it is conducive to promoting regulatory agencies to form a joint force, combining penalties with individual accountability and industry exit mechanisms to create deterrence, and using integrity supervision to promote the healthy and positive development of the industry. These new regulations and measures not only adapt to the new requirements of medical device regulation under the new situation but also promote the innovation of medical device regulatory methods, reflecting the application of scientific research results in medical device regulation to regulatory decision-making and optimization of regulatory measures.

Improve the review and approval system to stimulate social innovation vitality.

The original "Regulations" were formulated in 2000, comprehensively revised in 2014, and partially modified in 2017. This revision is a modification aimed at institutionalizing the achievements of the reform of the drug and medical device review and approval system in response to the new situation of rapid industrial development and deepening reforms in recent years.

A good system is a guarantee of high-quality development. During the revision process of the new version of the "Regulations," relevant functional departments in China carefully analyzed the deep-seated institutional problems exposed in daily regulatory work, fully drew on advanced international regulatory experiences, promoted intelligent regulation, and further improved the level of China's medical device review and approval system by optimizing approval procedures and improving the review and approval system. This is specifically reflected in changing the clinical trial approval to implied permission, shortening approval time; allowing registrants to submit product self-inspection reports, further reducing R&D costs; allowing conditional approval for urgently needed medical devices for treating rare diseases, severe life-threatening conditions, and responding to public health emergencies, meeting patient needs under specified conditions after assessing that benefits outweigh risks; increasing the emergency use system for medical devices based on the experience of COVID-19 prevention and control, enhancing the ability to respond to major public health emergencies; and so on.

Compared with traditional regulation, information-based regulation has the advantages of speed, convenience, and wide coverage. Information construction is one of the important tasks to improve regulatory capacity and service levels.

In this regard, the new version of the "Regulations" also makes adjustments, clarifying that the state will strengthen the construction of medical device regulatory information, improve online government service levels, and provide convenience for medical device administrative licensing, filing, etc. Information on registered or filed medical devices will be publicly announced to society through the online government service platform of the State Council's drug regulatory department.

Zhao Yixin, president of the China Medical Device Industry Association, believes that the implementation of the above measures will further improve regulatory work efficiency, reduce the review and approval costs for registrants, and at the same time comprehensively, accurately, and timely inform the public about the information of marketed products, guide the public in using devices, accept social supervision, and improve government regulatory transparency. In addition, the new version of the "Regulations" stipulates that the state will formulate medical device industry planning and policies, incorporate medical device innovation into development priorities, support the clinical promotion and use of innovative medical devices, enhance independent innovation capabilities, promote high-quality development of the medical device industry, and will formulate and improve specific industry planning and guiding policies for implementation; improve the medical device innovation system, support basic and applied research, and provide support in areas such as scientific project approval, financing, credit, bidding procurement, and medical insurance. The purpose of these regulations is to further stimulate social innovation vitality and promote China's transition from a major medical device manufacturing country to a strong manufacturing country.

Source: Legal Daily

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