China's Medical Device Exports Continue to Grow, with III Class Devices Standing Out.As of February 2024, the total number of registered Class II and III medical devices in China is 133,901, with 185,633 filings. From 2019 to 2022, the number of product registrations and filings increased annually, with an overall annual growth rate of about 36.2%. It is evident that China is increasingly focusing on the development of high-end Class II and III medical devices, with the number of registrations showing a steady upward trend.
In the first seven months of this year, China’s medical device exports reached $12.1 billion, marking a 2.36% year-on-year increase. During this period, the export value of Class III medical devices (the highest risk and most strictly regulated devices) was $3.9 billion, accounting for 32.37% of the total export value. This represents a significant increase from 28.6% in 2018, highlighting China's growing international competitiveness in high-risk medical devices.
Conversely, the export share of low-risk Class I medical devices (such as syringes, needles, and gauze) was 25.27%, down from 30.55% in 2018. This shift indicates an increased demand for high-end medical instrument while the demand for low-risk devices has relatively decreased.
China's price advantage is also a key factor in the growth of medical device exports. Typically, Chinese medical devices are 20-30% cheaper than those from other countries, giving them a strong competitive edge in the international market. Data shows that China's share of global medical device exports has risen from 3% in 2000 to 11% in 2021.While the primary export destinations are developing countries, the United States remains China's largest export market for medical devices. From January to July, exports to the U.S. accounted for 18.47% of the total, with advanced Class III devices representing 21% of this figure.
Additionally, China's medical device exports to the European Union and ASEAN countries have also shown strong performance. During the same period, 14.24% of China's medical devices were exported to the EU, and 8.2% to ASEAN countries. These figures demonstrate the broad scope and expanding influence of Chinese medical devices in the global market.