The Regulations for the Supervision and Administration of Medical Devices (Revised Draft) was approved at the executive meeting of the State Council on December 21, 2020. The State Council officially promulgated the Regulations for the Supervision and Administration of Medical Devices (2021) on February 9, 2021. The formal enforcement on June 1 marks a new stage for the reform of medical device review and approval in China.
316 innovative program products were included, with 109 products approved.
It is learned that in order to implement the national spirit of deepening reform and encouraging innovation, the Special Approval Procedures for Innovative Medical Devices (Trial) was formulated in February 2014; afterwards, in order to implement the Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (TZ [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, encourage R&D innovations of medical devices, enhance the promotion and application of new technologies of medical devices, and promote the high-quality development of medical device industry, National Medical Products Administration (NMPA) organized to revise the Special Approval Procedures for Innovative Medical Devices in 2018.
The Center for Medical Device Evaluation of the National Medical Products Administration (hereinafter referred to as the “CMDE”) acted as an implementing unit and cooperated with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials. With the help of the rich expert resources of the societies, authoritative experts and scholars in relevant research fields were selected to put forward review opinions.
Statistically, the CMDE entrusted the two societies to organize and hold more than 520 expert review meetings on innovative medical devices during 2018-2020. Meanwhile, the CMDE established a joint review mechanism for the collective research on experts’ review opinions and relevant issues in the form of member working meeting jointly with the Department of Medical Device Registration and societies. As of May 26, 2021, the CMDE has received 1,554 applications for special review of innovative medical devices. 316 innovative program products were included, with 109 products approved.
Improving the innovation system and introducing global latest medical technologies to China
The Regulations for the Supervision and Administration of Medical Devices (2021) specified that China will develop plans and policies for medical device industry, include medical device innovation into development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of medical device industry. The Drug Supervision and Administration Department of the State Council shall cooperate with the relevant departments of the State Council to implement the national planning and guidance policies for the medical device industry (Article 8). In the meantime, China will improve the medical device innovation system, and support the basic research and applied research of medical devices, as well as science and technology project approval, financing, credit, bid procurement, medical insurance and other aspects. Moreover, China will support enterprises establish or jointly establish R&D institutions, encourage enterprises to carry out medical device research and innovation in cooperation with institutions of higher learning, research institutes, medical institutions and so on, strengthen the protection of intellectual property rights of medical devices, and improve the capability of independent innovation in medical devices (Article 9).
In addition, the Regulations for the Supervision and Administration of Medical Devices (2021) implemented effective reform measures to promote and encourage innovation carried out by the Regulations for the Supervision and Administration of Medical Devices in recent years. Such measures include: the implementation of the medical device MAH system to further reduce the burden on enterprises; giving commendation and rewards to units and individuals that have made outstanding contributions to the research and innovation of medical devices in accordance with the relevant national regulations (Article 12) to accelerate the transformation of scientific research and technological achievements in the medical field.
It is worth mentioning that the Regulations for the Supervision and Administration of Medical Devices (2021) provided that, the registration of imported innovative medical devices will no longer require the certification documents issued by the competent authorities of the country (region) where the registrant to permit the marketing of the medical devices, encouraging the application of the latest global medical technologies in China.
Following the principle of scientific supervision and improving review technology reserves
The Regulations for the Supervision and Administration of Medical Devices (2021) also clearly stated that, the supervision and administration of medical devices shall following the principle of scientific administration. Previously, the CMDE has participated in the research work of the first batch of four key projects, including the safety and effectiveness evaluation of artificial intelligence (AI) medical devices, the methodological research of applying real world data to the clinical evaluation of medical devices, the technical evaluation research of drug device combination products and the supervision of new materials for medical devices.
Next, the CMDE will consolidate the achievements of reform of the review and approval system, properly implement the new Regulations for the Supervision and Administration of Medical Devices (2021), continue to promote the review of innovative medical devices and supervise scientific research, focus on the demand for the high-quality development of the medical device industry, spare no efforts to provide services in solving bottlenecks and other aspects, and make positive contributions to promote the high-quality development of independent innovating medical device industry in China, facilitate the early marketing of China’s high-end medical devices on the basis of safety and effectiveness, and meet the people’s needs for medical and health care.
Source: Pharmaceutical Economic News
316 innovative program products were included, with 109 products approved.
It is learned that in order to implement the national spirit of deepening reform and encouraging innovation, the Special Approval Procedures for Innovative Medical Devices (Trial) was formulated in February 2014; afterwards, in order to implement the Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (TZ [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, encourage R&D innovations of medical devices, enhance the promotion and application of new technologies of medical devices, and promote the high-quality development of medical device industry, National Medical Products Administration (NMPA) organized to revise the Special Approval Procedures for Innovative Medical Devices in 2018.
The Center for Medical Device Evaluation of the National Medical Products Administration (hereinafter referred to as the “CMDE”) acted as an implementing unit and cooperated with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials. With the help of the rich expert resources of the societies, authoritative experts and scholars in relevant research fields were selected to put forward review opinions.
Statistically, the CMDE entrusted the two societies to organize and hold more than 520 expert review meetings on innovative medical devices during 2018-2020. Meanwhile, the CMDE established a joint review mechanism for the collective research on experts’ review opinions and relevant issues in the form of member working meeting jointly with the Department of Medical Device Registration and societies. As of May 26, 2021, the CMDE has received 1,554 applications for special review of innovative medical devices. 316 innovative program products were included, with 109 products approved.
Improving the innovation system and introducing global latest medical technologies to China
The Regulations for the Supervision and Administration of Medical Devices (2021) specified that China will develop plans and policies for medical device industry, include medical device innovation into development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of medical device industry. The Drug Supervision and Administration Department of the State Council shall cooperate with the relevant departments of the State Council to implement the national planning and guidance policies for the medical device industry (Article 8). In the meantime, China will improve the medical device innovation system, and support the basic research and applied research of medical devices, as well as science and technology project approval, financing, credit, bid procurement, medical insurance and other aspects. Moreover, China will support enterprises establish or jointly establish R&D institutions, encourage enterprises to carry out medical device research and innovation in cooperation with institutions of higher learning, research institutes, medical institutions and so on, strengthen the protection of intellectual property rights of medical devices, and improve the capability of independent innovation in medical devices (Article 9).
In addition, the Regulations for the Supervision and Administration of Medical Devices (2021) implemented effective reform measures to promote and encourage innovation carried out by the Regulations for the Supervision and Administration of Medical Devices in recent years. Such measures include: the implementation of the medical device MAH system to further reduce the burden on enterprises; giving commendation and rewards to units and individuals that have made outstanding contributions to the research and innovation of medical devices in accordance with the relevant national regulations (Article 12) to accelerate the transformation of scientific research and technological achievements in the medical field.
It is worth mentioning that the Regulations for the Supervision and Administration of Medical Devices (2021) provided that, the registration of imported innovative medical devices will no longer require the certification documents issued by the competent authorities of the country (region) where the registrant to permit the marketing of the medical devices, encouraging the application of the latest global medical technologies in China.
Following the principle of scientific supervision and improving review technology reserves
The Regulations for the Supervision and Administration of Medical Devices (2021) also clearly stated that, the supervision and administration of medical devices shall following the principle of scientific administration. Previously, the CMDE has participated in the research work of the first batch of four key projects, including the safety and effectiveness evaluation of artificial intelligence (AI) medical devices, the methodological research of applying real world data to the clinical evaluation of medical devices, the technical evaluation research of drug device combination products and the supervision of new materials for medical devices.
Next, the CMDE will consolidate the achievements of reform of the review and approval system, properly implement the new Regulations for the Supervision and Administration of Medical Devices (2021), continue to promote the review of innovative medical devices and supervise scientific research, focus on the demand for the high-quality development of the medical device industry, spare no efforts to provide services in solving bottlenecks and other aspects, and make positive contributions to promote the high-quality development of independent innovating medical device industry in China, facilitate the early marketing of China’s high-end medical devices on the basis of safety and effectiveness, and meet the people’s needs for medical and health care.
Source: Pharmaceutical Economic News