On July 6, 2025, a new regulation on medical device procurement issued by the Ministry of Finance officially came into effect, causing a stir in the medical device industry. This new regulation is highly targeted, standardizing the government's procurement of medical devices from multiple aspects and having a profound impact on the development of the industry.

The new regulation clarifies the scope of application and thresholds, covering only medical device projects with a government procurement budget of ≥ 45 million RMB (including single equipment or combined procurement). In terms of restricted entities, enterprises with headquarters in the European Union, such as Siemens Healthineers and Philips, are directly excluded from bidding qualifications, regardless of the origin of their products. If non-EU enterprises participate in the bidding, the proportion of the amount of EU-origin medical devices they provide must be ≤ 50% (based on the country of origin in the customs declaration). However, localized products (of the "National Medical Device Approval" type) of EU-funded enterprises in China, such as Johnson & Johnson China and Siemens Shanghai, are not restricted. The restricted product categories cover eight major categories, including medical magnetic resonance equipment, surgical navigation systems, and laser treatment equipment, which are subdivided according to the "Classification Catalogue of Government Procurement Items". It is worth noting that this policy does not apply to the centralized procurement of drugs, medical consumables, and the procurement by state-owned enterprises.

The new regulation also sets out exception clauses and transitional arrangements. If clinical needs can only be met by EU products, such as equipment for specific rare diseases, the restriction can be exempted after expert demonstration, but technical evaluation materials must be submitted, and such cases are strictly controlled within 3% of the total procurement volume. For projects that have already been tendered, those with winning bid announcements issued before July 6, 2025, can continue to implement the original contracts. After splitting large-scale projects into sections, each sub-package must independently meet the 50% EU import proportion limit.

From the perspective of the policy background, this is a reciprocal response to relevant EU restrictions. In June 2025, the EU introduced measures to restrict Chinese medical devices from participating in its public procurement, such as stricter MDR regulations and localization priority policies. China's move aims to counter EU protectionism and promote fair trade. At the same time, the new regulation also focuses on accelerating domestic substitution and ensuring supply chain security, with the goal of increasing the localization rate of high-end equipment such as CT/MRI from the current 30% to 45% by 2026, and encouraging multinational enterprises to establish R&D centers and production lines in China.

The market impact is also significant. Domestic enterprises are facing major opportunities. Companies such as United Imaging Healthcare and Mindray Medical will have more obvious advantages in winning bids for projects above 45 million RMB, which will also force domestic enterprises to accelerate the breakthrough of core component technologies such as medical sensors and high-precision optical modules. Multinational enterprises need to adjust their strategies. EU enterprises should avoid restrictions through production bases in China or cooperate with non-EU suppliers, while accelerating the domestic substitution of key components. Procurers also face compliance challenges. Hospitals need to organize expert groups to prove that "only EU products can meet the needs", which increases the demonstration cost, and they need to expand channels for suppliers from Japan, South Korea, the United States and domestic sources to reduce dependence on a single source.

The new regulation on medical device procurement by the Ministry of Finance reshapes the pattern of the government procurement market for medical devices from multiple dimensions. All parties need to actively adapt and seize new development opportunities.