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2021 Status Quo and Analysis of China's Medical Device Import Market and Sub-segments: Decline in Imports of High- and Mid-range Medical Devices
Release time:
2025-03-12 09:40
Major listed companies in the medical device industry:Mindray Medical(300760),BGI Genomics(300676),DIANDIAGNOSTICS(300244),Meican Bio(300439),Yuwell Medical(002223), etc.
Core data of this article:Number of imported medical devices, import ranking of high-end medical devices
Class Ⅰ medical devices are imported the most
Currently, China implements a classification management system for medical devices based on risk levels: Class Ⅰ refers to medical devices with low risk levels, whose safety and effectiveness can be ensured through routine management. Class Ⅱ refers to medical devices with moderate risk levels, requiring strict control management to ensure their safety and effectiveness. Class Ⅲ refers to medical devices with high risk levels, requiring special measures and strict control management to ensure their safety and effectiveness.
By the end of 2020, a total of 26,713 imported medical devices were recorded in China, a decrease of 1,904 units (6.7%) compared to the end of 2019. Among them, 9,694 were Class Ⅰ, 9,053 were Class Ⅱ, and 7,966 were Class Ⅲ. A total of 2,421 agents for imported products were recorded, a decrease of 4% compared to 2019.
Decline in imports of high-end medical devices
Compared with the end of 2019, the number of imported Class Ⅰ medical devices in China increased by 7.9% in 2020, while the number of imported Class Ⅱ and Class Ⅲ medical devices decreased significantly by 11.7% and 15.1%, respectively. This shows a decline in the import of high-end medical devices in China.
From the perspective of high-end medical device sub-categories, the number of imported in-vitro diagnostic reagents reached 4,962 in 2020, ranking first; passive implantable devices ranked second with 1,639 imports; and dental devices ranked third with 1,461 imports.
However, in terms of import volume, the import volume of the top ten high-end medical devices in 2020 decreased compared to the previous year, with a decrease of more than 100 units for each product. These products also experienced the largest decrease in imports among high-end medical devices in China in 2020.
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