Reporter Wan Jing
Recently, the State Administration for Market Regulation issued the Administrative Measures for the Registration and Filing of Medical Devices (hereinafter referred to as the Measures) and the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents, which came into effect on October 1.
The Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations), which have been in force for more than 20 years, were overhauled last year and officially implemented on June 1 this year. As one of the important administrative supporting administrative rules and regulations of the Regulations, the Measures systematically make operable detailed provisions on China's medical device registration and filing system from the aspects of medical device registration, special registration procedures, change registration and continuation of registration, medical device filing, work time limit, supervision and management, legal liability, etc., marking a new chapter in China's medical device registration and filing management system.
Refine registration requirements
In recent years, with the joint promotion of various aspects of national regulatory policies, many categories of domestic medical devices have flourished, and imports can be replaced. However, at present, domestic medical device manufacturers are also facing the problem of small and scattered, and the innovation ability needs to be improved urgently.
The Regulations focus on the implementation of the medical device registrant and recorder system in order to strengthen the main responsibility of enterprises. In order to reflect the characteristics of "the registrant system has become a new regulatory highlight" in the Regulations, the Measures have improved and refined the medical device registration and filing management system from the aspects of fully implementing the medical device registrant and recorder system, encouraging the innovative development of medical devices, improving technical requirements such as clinical evaluation, and increasing penalties for illegal acts.
The Measures focus on summarizing the experience of encouraging medical device innovation and promoting the listing of medical device products urgently needed in clinical practice in recent years, and add a special chapter on special registration procedures to stipulate the registration procedures and priority registration procedures for innovative products; Summarizing the experience of carrying out emergency approval of medical devices in recent years, especially in the prevention and control of the new crown pneumonia epidemic, the emergency registration procedures are stipulated, and the scope of inclusion and support policies of each procedure are clarified.
Yu Qingming, secretary of the Party Committee of Sinopharm Holdings Co., Ltd. and deputy to the 13th National People's Congress, believes that the medical device registrant system will bring huge reform dividends, mainly reflected in three "benefits": that is, it is conducive to optimizing the allocation of resources, promoting industrial concentration, and enhancing competitiveness; It is conducive to encouraging innovation and shortening the product launch cycle; It is conducive to promoting supply-side structural reform, eliminating "low, small and scattered", boosting industrial restructuring and achieving high-quality development.
Unleash innovation
The Measures summarize the achievements of the medical device review and approval reform in recent years, add a special chapter on special registration procedures, include special registration procedures such as innovative product registration procedures, priority registration procedures, and emergency registration procedures, and clarify the scope, procedures, and support policies of each channel.
The Measures also summarized the experience of carrying out emergency approval of medical devices in the prevention and control of the new crown pneumonia epidemic. The Measures stipulate the emergency registration procedures for medical devices, clarifying that the State Food and Drug Administration may implement emergency registration for medical devices that are required for emergency response to public health emergencies and have no similar products listed in China, or that have similar products on the market in China but whose product supply cannot meet the needs of emergency handling of public health emergencies.
The Measures implement the requirements of the "implied permission" for clinical trial approval in the Regulations, clarifying that "a decision on whether to agree to a clinical trial application shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the Device Evaluation Center of the State Bureau." If the notice is not given within the time limit, it shall be deemed to be consent.".
The Measures also include expanded clinical trials, stipulating that for medical devices that are currently undergoing clinical trials for the treatment of seriously life-threatening diseases that are not yet effectively treated, medical observation may benefit patients, and after ethical review and informed consent, they can be used free of charge for other patients with the same condition in institutions carrying out clinical trials of medical devices, and their safety data can be used for medical device registration applications.
Innovation is the first driving force leading the development of the medical device industry. The Measures further implement the legislative spirit of the Regulations to encourage medical device innovation, clearly stipulating that priority approval is given to medical devices urgently needed for clinical use, and special approvals are implemented for innovative medical devices, encouraging research and innovation of medical devices, and promoting the high-quality development of the medical device industry. At the same time, it is pointed out that for innovative medical devices that are not listed overseas, it is no longer necessary to submit overseas listing certificates, so as to encourage "global new" products to be listed in China as soon as possible.
Zhao Yixin, president of the China Medical Device Industry Association, believes that the implementation of the above measures will further improve the efficiency of supervision, reduce the cost of review and approval of registration applicants, the state formulates medical device industry planning and policies, incorporates medical device innovation into the development focus, supports the clinical promotion and use of innovative medical devices, improves independent innovation capabilities, promotes the high-quality development of the medical device industry, and implements special approvals for innovative medical devices, the purpose of these provisions is to further stimulate the vitality of social innovation. Promote China's leap from a big country in medical device manufacturing to a manufacturing power.
Establish a verification system
The registration process of medical devices is a process of reviewing the safety, effectiveness and quality controllability of the products to be marketed, so the Measures implement the "four strictest" requirements, clarify the responsibilities of the State Food and Drug Administration, the technical institutions of the State Food and Drug Administration, and the provincial Food and Drug Administration, give full play to the strength of regulatory departments at all levels, strengthen the supervision of medical devices after filing, and clarify regulatory measures such as extended inspection, credit files of clinical trial institutions, and responsibility interviews.
The reporter noted that the "Measures" established a registration system verification system. It stipulates that the drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government shall carry out quality management system verification in accordance with the requirements of the good manufacturing practices for medical devices, focusing on whether the applicant has established a quality management system suitable for the product in accordance with the requirements of the good manufacturing practices for medical devices, as well as the design and development, production management, and quality control related to product development and production. In the process of verification, the authenticity of the products for inspection and clinical trials shall be verified at the same time, focusing on the relevant records of the design and development process and the relevant records of the production process of the inspection products and clinical trial products.
Product development is a key link before the registration of medical device products, which is directly related to the safety, effectiveness and quality controllability of medical device products. Therefore, the Measures add relevant content of "product development", clarify the principles of risk management, non-clinical research, etc., and stipulate that "the development of medical devices shall follow the principle of risk management, consider the existing recognized technical level, ensure that all known and foreseeable risks and unintended impacts of products are minimized and acceptable, and ensure that the benefits of products in normal use outweigh the risks".
The Measures also stipulate that the drug regulatory authorities shall strengthen the supervision and inspection of the development activities of medical devices, and when necessary, may conduct extended inspections of units and individuals that provide products or services for the development of medical devices. Not only that, if the drug regulatory authorities deem it necessary, they can conduct on-site inspections of the authenticity, accuracy, completeness, standardization and traceability of clinical trials.
In this regard, Xiong Wenzhao, a professor at the Law School of the Central University for Nationalities, believes that refining the medical device registration and filing system and strictly implementing the relevant provisions of the Regulations on the development, production, operation and use of medical devices can further enhance the efficiency of medical device supervision, protect the healthy medical device industry development environment and market order, and effectively guarantee the safety of the people's use of medical devices.