On January 27, the State Food and Drug Administration released the “2021 Medical Device Registration Work Report” (hereinafter referred to as the “Report”). The “Report” shows that in 2021, the State Food and Drug Administration approved the launch of 35 innovative medical devices, an increase of 35% compared with 2020; emergency approval of 14 new coronavirus detection reagents; and approved 1,710 first-time registrations, an increase of 8.8% compared with 2020.
According to the “Report”, the State Food and Drug Administration will continue to carry out emergency approval work for the prevention and control of the new coronavirus epidemic in 2021, and approved a total of 14 new coronavirus detection reagents throughout the year. As of the end of 2021, my country has approved a total of 68 new coronavirus detection reagents, with a production capacity of 51.306 million doses/day, providing a strong guarantee for normalized epidemic prevention and control. At the same time, the monitoring of new coronavirus mutant strains and the assessment of reagent detection capabilities were initiated to ensure the quality of approved reagents for detecting new coronavirus mutant strains.
The “Report” points out that the new framework of the medical device registration management regulatory system in 2021 will be gradually completed. With the promulgation and implementation of the newly revised “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “Regulations”), the State Food and Drug Administration has absorbed the results of the review and approval system reform, fully implemented the medical device registrant system, scientifically set evaluation requirements, and encouraged innovative development, from the application material requirements, procedures, and operating specifications Detailed regulations have been made in other aspects, and the “Measures for the Registration and Filing Management of Medical Devices”, “Measures for the Registration and Filing Management of In Vitro Diagnostic Reagents”, “Announcement on the Publication of the Requirements for Medical Device Registration Application Documents and the Format of Approval Documents”, etc., have been implemented one by one to implement the registration management requirements of the newly revised “Regulations”.
At the same time, the State Food and Drug Administration continued to encourage the high-quality development of medical devices and approved the listing of 35 innovative medical devices such as coronary blood flow reserve fraction calculation software; in accordance with the priority medical device approval procedures, approved the listing of 19 medical devices such as hereditary deafness gene detection kits; established a biomaterials innovation cooperation platform, and cooperated with the industry and information department to launch artificial intelligence The smart medical device innovation task will be unveiled and lead the work, establish a master document registration system, and accelerate the launch of new materials, new technologies, and new products; continue to support the construction of key areas such as the Hainan Boao Lecheng International Medical Tourism Pioneer Zone and the Guangdong-Hong Kong-Macao Greater Bay Area; optimize the requirements for listing certification of drug-device combination products, and accelerate the pace of the launch of drug-device combination products with clinical value.
The “Report” shows that the State Food and Drug Administration has made great efforts to lay a solid foundation for medical device registration and management. The standard system has continued to improve, classification and naming work has become more effective, unique identification work has steadily advanced, substantive progress has been made in the construction of sub-centers, and technical review standards have been standardized and unified. At the same time, we will continue to provide training on medical device registration regulations, initiate research on regulatory systems, continue to promote regulatory scientific research, conduct in-depth international exchanges and cooperation, and effectively strengthen the construction of medical device registration management capabilities.
In 2021, the State Food and Drug Administration will strengthen the supervision and management of medical device registration, carry out the clean-up and standardization work for Class I medical devices, strengthen clinical trial management, and deploy the clean-up and standard work for Class II medical devices. According to the “Report”, a total of 11,314 initial registrations, renewal registrations and change registrations of medical devices were approved in 2021. Compared with 2020, the total number of registration approvals increased by 14.9%. Among them, 1,710 were registered for the first time, an increase of 8.8% compared with 2020.