In 2021, the China National Medical Products Administration (NMPA) received 12,255 registration applications of new medical devices, an increase of 15.8% from 2020. Among that, 3715 (30.3%) are IVD products, 56.8% of which come from overseas suppliers. 

China’s IVD market was USD 12.5 billion in 2020 and is expected to value USD 21 billion in 2028. Immunoassays diagnostics has become the mainstream technology since 2020, replacing the clinical chemistry diagnostics which has been dominated by the Chinese manufacturers. Multinational companies compete head-to-head with China’s leading players in this field. Molecular diagnostics remain a niche market, which has attracted domestic leaders’ R&D investment. 

Although classified under the medical device category in China, IVD is subject to a similar but separate NMPA regulation with different registration requirements. Additionally, IVD products are normally less impacted by the government-controlled bulk-purchasing program or the volume-based procurement than other medical devices, because most IVD devices and reagents are exclusively matched. It is difficult to categorize and standardize IVD products in order to proceed large-volume procurement. 

Best prospects for U.S. companies include immunodiagnostics, POCT diagnosis, high-speed biochemical analyzers, automated laboratory assembly lines, and high-end molecular diagnostic equipment.

For more information contact:Wuhan - Catherine.le@trade.govShanghai - Xiaoli.Pan@trade.gov Beijing - Ming.Yang@trade.gov