EU Implements 5 Million Euro Restriction on Chinese Medical Devices

On June 20, 2025, the European Commission announced new rules restricting Chinese companies from participating in public medical device tenders exceeding 5 million euros. Additionally, procurement contracts must ensure that the proportion of outsourced work or equipment from Chinese manufacturers does not exceed 50%. This policy, covering a 150 billion euro market, spans products from masks and bandages to state-of-the-art medical robots and will take effect in 10 days. Non-public procurement channels remain unaffected.

The move has drawn sharp criticism from China’s Ministry of Foreign Affairs, with spokesperson Guo Jiakun accusing the EU of practicing double standards. Guo emphasized that China adheres to high levels of market openness and urged the EU to honor its commitment to fair trade under World Trade Organization (WTO) rules. He warned that such measures signal a drift toward protectionism, undermining the principle of fair competition.

Industry insiders, however, remain calm. Orders exceeding 5 million euros—equivalent to 40 million RMB—are rare in the global medical device market. Such contracts typically involve ultra-high-value equipment like proton therapy systems, PET-CT scanners, and advanced MRI machines, or comprehensive hospital renovation projects that require both equipment and infrastructure.

Analysts argue that Chinese companies currently lack the global trust and long-term relationships with European healthcare institutions that competitors like Siemens, Philips, and Roche Diagnostics enjoy. While major players like Mindray Medical and United Imaging have established a foothold in Europe, their presence remains relatively small. For example, Mindray's 2024 revenue of 367.26 billion RMB derived only 8% from Europe, while over 60% came from developing countries.

United Imaging may face greater challenges due to its focus on high-ticket imaging products like PET-CT. By the end of 2024, it had penetrated over 15 EU countries, contributing 22 billion RMB to its total revenue. Nonetheless, most Chinese medical device companies lack the scale or international networks to compete effectively for large contracts in the EU market.

While the new law may reflect geopolitical tensions, industry experts believe its short-term impact will be minimal, as most Chinese medical device exports to Europe involve smaller contracts that fall below the 5 million euro threshold.