The “2023 Medical Device Blue Book” compiled and issued under the guidance of the State Food and Drug Administration shows that as of the end of 2022, the total number of medical device manufacturers in my country has reached 32,632, with operating revenue of approximately 1.24 trillion yuan, an increase of approximately 20% over the previous year, accounting for approximately 27% of the global medical device market.
The “Blue Book” shows that the State Food and Drug Administration encourages the innovative development of medical devices and continuously improves the quality and efficiency of review. The completion rate of medical device review tasks within the time limit remains above 99%. In 2022, a total of 55 innovative medical devices will be approved for marketing. my country’s medical device industry will continue to maintain a rapid development rate. The overall quality of future medical device products will steadily improve, innovative medical devices will emerge at an accelerated pace, new breakthroughs will be made in the research and development of key core technologies and key spare parts for some high-end medical devices, and the safety and effectiveness of public devices will be more effectively guaranteed.
From 2015 to 2022, the global medical device industry market size has shown an upward trend year by year. In 2022, the global medical device market size will reach US$532.8 billion, a year-on-year increase of 5.65%.
The blue book points out that there are four key development directions for medical device registration management.
(1) Encourage and support the high-quality development of the medical device industry
Focus on high-end medical devices, “global new” medical devices, key components and technologies that solve the “stuck neck” problem, and increase review and approval support. Priority approval will be implemented for medical devices that are urgently needed for clinical use, supported by key national scientific research projects, and that are deployed by the country to tackle key core technologies. Give full play to the role of artificial intelligence medical devices and biomaterials innovation cooperation platform, and accelerate the integration process of government, industry, academia, research and application. Continue to coordinate and promote the clinical real-world data application pilot work in Hainan Boao Lecheng Pilot Zone, promote the implementation of medical device policies and measures in the Guangdong-Hong Kong-Macao Greater Bay Area, and support Macao in establishing and improving the medical device regulatory system.
(2) Improve the “one-game chess” work pattern of medical device registration management
Formulate the “Regulations on the Management of Emergency Use of Medical Devices” to accelerate the research and formulation of regulations for medical institutions that urgently need small quantities of imported medical devices for clinical use and for medical institutions to develop their own medical devices during public health emergencies. Improve the regulations on the production of imported registered medical devices by enterprises in China, and encourage high-level foreign medical devices to be produced in China. Strengthen the organizational guidance for the pilot work of medical institutions to develop and use in vitro diagnostic reagents on their own. Continue to promote the registration, cleanup and standardization of domestic Class II medical devices. Actively support the capacity building of the two review and inspection sub-centers. Increase efforts to formulate and revise the guiding principles for technical review of Class II medical device registration, and continue to unify review and approval standards.
(3) Strengthening clinical trial supervision
In order to guide and standardize the supervision and inspection of clinical trials of medical devices, we formulate inspection points related to clinical trial institutions and projects, and organize clinical trial supervision and inspections in 2023. Continue to strengthen the construction of clinical trial supervision capabilities. Organize all localities to promptly investigate and deal with illegal activities related to the registration process, and resolutely crack down on providing false declaration materials and using other deceptive means to obtain registration certificates during the registration application process.
(4) Improve the technical support system
Organize the research and preparation of medical device standard plans, continue to implement the standard improvement plan, and carry out the formulation and revision of medical device standards in 2023. Revise the “Working Rules for the Approval and Release of Medical Device Standards” to strengthen work related to standard verification and implementation evaluation. Encourage universities, scientific research institutions, medical device registrants and other entities to actively participate in the formulation and revision of medical device standards. In order to further strengthen the management of the work of the Standardization Committee, a full-coverage assessment and evaluation of the Standardization Committee and the technical focal point units was carried out. In order to promote the implementation of the new version of the GB 9706 series of standards, we actively carry out publicity and training, inspection and testing research and other work to ensure that the standards are scientifically and steadily implemented. Formulate and publish opinions on further strengthening and improving the classification management of medical devices, and coordinate and deploy the classification management of medical devices in the future. Promote the revision of the “Classification Catalog of In Vitro Diagnostic Reagents” and “Classification Rules for Medical Devices”. Carry out dynamic adjustment of classification directories in an orderly manner. Organize and carry out research on the application of unique identification of medical devices and the connection between classification and coding of medical insurance consumables. Actively participate in global medical device safety governance, deeply participate in relevant work of international organizations such as IMDRF and GHWP, closely track global medical device regulatory trends and hot spots, continue to deepen bilateral and multilateral international cooperation, and promptly transform and apply international regulatory rules.
my country’s medical device industry will continue to maintain a rapid development rate. The overall quality of future medical device products will steadily improve, innovative medical devices will emerge at an accelerated pace, new breakthroughs will be made in the research and development of key core technologies and key spare parts for some high-end medical devices, and the safety and effectiveness of public devices will be more effectively guaranteed. In the next step, the State Food and Drug Administration will carry out in-depth special rectification work on the quality and safety of medical devices, focusing on key products such as centralized procurement and selection, key links such as online sales, and key areas such as medical beauty use, and do a solid job in quality and safety supervision.