Data statistics from January 1, 2022 to December 31, 2022
In 2022, the State Food and Drug Administration continue to focus on people’s health, continue to do a good job in the review and approval of epidemic prevention and control products, comprehensively deepen the reform of the medical device review and approval system, strengthen the registration management of medical devices, and promote the high-quality development of industrial innovation.
In 2022, the State Food and Drug Administration approved a total of 11,942 medical device registrations, an increase of 5.5% over 2021. There were 2,500 first-time registrations, an increase of 46.2% over 2021; 5,218 renewal registrations, a decrease of 24.8% over 2021; and 4,224 change registrations, an increase of 58.5% over 2021. 5,692 domestic Class III medical device registrations were approved, an increase of 23.8% over 2021. 6,250 items of medical devices were approved for import, a decrease of 7% compared to 2021. There were 2985 registrations of imported Class II medical devices and 3265 registrations of imported Class III medical devices.
Except for in vitro diagnostic reagents, the top five domestic Class III medical devices with the largest number of registrations:
1. Passive Implantable Devices
2. Neurological and Cardiovascular Surgical Devices
3. Infusion, nursing and protective equipment
4. Medical Imaging Devices 5. Active Surgical Instruments
The top five imported medical devices with the largest number of registrations:
1. Medical Imaging Devices
2. Passive Implantable Devices
3. Infusion, nursing and protective equipment
4. Dental instruments
5. Neurological and Cardiovascular Surgical Devices
The number of first-time registrations of Class III medical devices in China ranks among the top five: 1. Jiangsu 2. Guangdong 3. Beijing 4. Shanghai 5. Zhejiang
Accounting for 69.7% of the first domestic registrations, an increase of 1.8% over 2021
A total of 28 countries (regions) have been approved for marketing in my country, and the number of first-time registrations ranks in the top five: the United States, Germany, Japan, South Korea, and France, accounting for 76.4% of the number of first-time registrations.
In 2022, the State Food and Drug Administration approved 55 innovative medical devices, and 77 medical devices were given priority approval. The number of approved innovative medical devices increased by 57.1% compared with 2021, better meeting the needs of the people to use high-level medical devices.
The Ministry of Industry and Information Technology jointly issued the list of shortlisted units for the innovation task of artificial intelligence medical devices, and started the work of revealing the innovation task of biomedical materials to further stimulate the vitality of industrial development. Print and distribute the implementation plan for Hong Kong and Macao medical device registrants to produce medical devices in 9 mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area. Leading the organization to promote the pilot work of clinical real-world data application in Lecheng International Medical Tourism Pioneering Zone, Boao, Hainan, approved the listing of four pilot varieties of hot steam therapy equipment and disposable prostate hot steam therapy equipment, and guided the holding of the first Boao Medical Device Real World Research Conference , New breakthroughs have been made in real-world data applications and research. The medical device registration management technical support system continues to improve .
In 2022, the State Food and Drug Administration approved 116 medical device industry standard formulation and revision plans, reviewed and issued 114 industry standards, and the coverage and systematicness of the standard system continued to improve. Make overall plans to promote the implementation of the GB9706 series of standards. Published 95 guiding principles for technical review of medical devices, with a total of 529 by the end of 2022.