Half Year Report on Registration of Listed Medical Devices in H1 2024
Summary and statistics of H1 registration and filing information in the first half of 2024:
– Number of registered approved medical devices 12,363 items
– Number of medical devices approved for filing 16941 items
– Priority approval of 58 registered medical devices
– Innovative Approval of Registered Medical Devices 82 items
01
Analysis of Medical Device Registration in H1 2024
According to the latest statistics, a total of 12,363 medical devices were approved for registration nationwide in H1 2024, a year-on-year decrease of 20.3%, of which 58 were approved for registration on a priority basis and 82 were approved for registration on an innovative basis; the number of medical devices approved for filing was 16,941, a year-on-year decrease of 17.8%.
In 2024 H1, a total of 12,363 medical device products were approved for registration nationwide. Among them, 10,487 domestic Class II medical device products, 1,405 domestic Class III medical device products, 231 imported Class II medical device products, and 240 imported Class III medical device products. The overall proportion of domestic products accounted 96.1 per cent.
In terms of product categories, the number of registrations of in vitro diagnostic reagents (2,845), injection, infusion, care and protection devices (2,671) and stomatological devices (923) ranked among the top three registered medical devices in H1 2024.
In H1 2024, prosthetic dental medical devices and protective medical device products accounted for the top ranked medical device registrations. Among them, the number of registrations of protective medical devices-medical protective masks decreased compared to the same period in 2023.
From the distribution of domestic Class II medical devices registered products source, there were 31 provinces and cities (excluding China, Hong Kong, Macao and Taiwan) registered Class II medical devices in 2024 H1, of which Jiangsu Province had the largest number of registered medical devices, accounting for 26.0% of the number of domestic Class II medical devices registered.
From the distribution of domestic Class III medical devices registered products source, there were 26 provinces and cities (excluding China, Hong Kong, Macao and Taiwan) registered Class III medical devices in 2024 H1, of which Jiangsu Province had the largest number of registered medical devices, accounting for 20.3% of the number of domestic Class III medical devices registered.
From the distribution of countries/regions of origin for imported Class II medical device registration products, a total of 25 countries/regions (including China, Hong Kong, Macao, and Taiwan) registered imported Class II medical devices in H1 2024, with the United States having the highest number of registered medical devices, accounting for 32.0% of the registered number of imported Class II medical devices.
From the distribution of countries of origin for imported Class III medical device registration products, a total of 19 countries/regions (including China, Hong Kong, Macao, and Taiwan) registered Class III medical devices in H1 2024, with the United States having the highest number of registered medical devices, accounting for 53.3% of the total number of imported Class III medical device registrations.
According to the Regulations on the Supervision and Administration of Medical Devices, Class I medical devices are managed through product filing.
The number of domestically produced Class I medical devices approved for filing in H1 2024 was 16721, a year-on-year decrease of 17.5%. At the same time, the number of approved registrations for imported Class I medical devices was 220, a year-on-year decrease of 32.3%.
02
Medical Device Innovation and Priority Approval in H1 2024
In H1 2024, a total of 82 innovative products were approved and registered nationwide, including 79 domestically registered products and 3 imported registered products. From the perspective of product categories: including 75 medical device products and 7 reagent products.
In H1 2024, a total of 13 provinces and cities registered domestically produced innovative medical devices for approval, with Jiangsu Province ranking first in the number of registrations with 24 items.
On October 25, 2016, the National Medical Products Administration issued the Priority Approval Procedure for Medical Devices, which came into effect on January 1, 2017. According to the Medical Device Priority Approval Procedure, priority approval shall be implemented for the following medical devices:
- Firstly, medical devices that diagnose or treat rare diseases, malignant tumors, and have significant clinical advantages, medical devices that diagnose or treat unique and multiple diseases in the elderly without effective diagnostic or treatment methods, and medical devices specifically designed for children with significant clinical advantages;
- Secondly, medical devices included in national major science and technology projects or national key research and development plans.
In addition, based on the situation and views of various parties, the organisation of expert review, to determine the ‘other medical devices should be given priority approval’ to be given priority approval.
In H1 2024, the total number of registered products for national priority approval wa s 58, including 56 domestic registered products and 2 imported registered products. In terms of product categories: including 42 device products and 16 reagent products.
A total of 14 provinces and cities registered medical devices for priority approval in H1 2024, with Chongqing ranking first in the number of registrations with 12.
03
Analysis of H1 Medical Device Registrants in 2024
By H1 2024, there are 4517 registered medical device companies in China. Among the top ten companies, the top three are: Autobio Comen、Life Origin Biotech ， Among them, Autobio ranks first in terms of registration quantity.
Autobio completed 157 medical device registrations in H1 2024, ranking first in the number of registered products, including 152 Class II IVD reagent products and 5 Class III IVD reagent products.
There have been 272 domestic registered imported medical device companies in H1 2024. Among the top ten companies, the top three are Medtronic Inc., ORGENTEC Diagnostika GmbH, and Boston Scientific Corporation), with Medtronic Inc. ranking first in the number of registered products.
In H1 2024, Medtronic Inc. registered 16 imported medical devices. From the perspective of management categories, it includes 5 Class II device products and 11 Class III device products.
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Source：药智医械数据-全球全产业链医疗器械数据库 (yaozh.com)
Translated & edited： Bradyknow
