According to a notice on the website of the Ministry of Finance, on July 6, the Ministry of Finance issued a notice regarding the implementation of relevant measures in government procurement activities for medical devices imported from the EU.
Central budget units, provincial, autonomous regional, and municipal finance departments (bureaus), and finance bureaus of planned cities, Xinjiang Production and Construction Corps:
Based on relevant laws and regulations, after approval, the Ministry of Finance has decided to implement relevant measures in government procurement activities for certain medical devices imported from the EU. The following matters are hereby notified:
1. When the procurement entity purchases medical devices with a budget amount exceeding RMB 45 million (specific items are listed in the attachment), and it is indeed necessary to purchase imported products, after fulfilling the legal procedures, EU enterprises (excluding EU-invested enterprises in China) shall be excluded from participation. For non-EU enterprises participating, the proportion of medical devices imported from the EU provided by them shall not exceed 50% of the total contract amount of the project. These measures do not apply to procurement projects where only medical devices imported from the EU can meet the procurement needs.
2. This notice will take effect from July 6, 2025. Procurement projects that have already announced winning or successful results before the implementation date may continue to sign government procurement contracts without implementing the measures stipulated in this notice.
Screenshot from the Ministry of Finance website
On July 10, the Ministry of Finance released policy Q&A regarding the notice on implementing relevant measures in government procurement activities for medical devices imported from the EU.
The notice "Regarding the Implementation of Relevant Measures in Government Procurement Activities for Medical Devices Imported from the EU" (Cai Ku [2025] No. 19, hereinafter referred to as the "Notice") has been in effect since July 6, 2025. The following answers are provided to questions raised by relevant parties:
1. How should the RMB 45 million limit specified in the Notice be understood? Is it the price of a single unit (set), the price of bulk purchasing, or the price of the procurement contract?
A: The RMB 45 million limit specified in the Notice refers to the budget amount of the government procurement project for medical devices. That is, if the budget amount of a government procurement project for medical devices reaches RMB 45 million or more, regardless of whether the procurement project involves the purchase of a single type of product, bulk purchasing of a single type of product, or the purchase of different types of products, the measures specified in the Notice shall be implemented.
2. Are the restricted entities the EU enterprises or the medical devices originating from the EU? If an EU enterprise provides products originating from the EU, does the 50% proportion limit apply? Are medical devices produced by EU enterprises in other countries and participating in Chinese government procurement within the scope of the measures?
A: For government procurement projects for medical devices with a budget amount exceeding RMB 45 million, EU enterprises shall be excluded from participation, regardless of the origin of the products they provide; for non-EU enterprises participating, if their products include medical devices imported from the EU, the proportion of medical devices imported from the EU in their products shall not exceed 50% of the total contract amount of the project. Whether the medical device is considered as imported from the EU is determined based on the country of origin stated on the customs declaration form.
3. How should the statement "the proportion of medical devices imported from the EU provided by non-EU enterprises shall not exceed 50% of the total contract amount of the project" in the Notice be understood?
A: For government procurement projects for medical devices with a budget amount exceeding RMB 45 million, if the procurement is not divided into packages, the proportion of medical devices imported from the EU provided by non-EU enterprises shall not exceed 50% of the total contract amount of the project. If the procurement is conducted in packages, the proportion of medical devices imported from the EU provided by non-EU enterprises shall not exceed 50% of the contract amount of each individual package after division. When the procurement entity divides the procurement into packages, it shall reasonably divide the procurement project based on actual procurement conditions, such as professional categories, fields, specifications, etc.
4. What does the phrase "excluding EU-invested enterprises in China" in the statement "after fulfilling the legal procedures, EU enterprises (excluding EU-invested enterprises in China) shall be excluded from participation" mean? Does it mean that EU headquarters enterprises established as legal entities in China are not subject to the measures specified in the Notice? Are medical devices produced by EU-invested enterprises in China (such as those approved by the National Medical Device Registration) affected by the provisions of the Notice?
A: For government procurement projects for medical devices with a budget amount exceeding RMB 45 million, EU-invested enterprises in China may participate. However, if their products include medical devices imported from the EU, the proportion of medical devices imported from the EU in their products shall not exceed 50% of the total contract amount of the project.
Enterprises that are wholly or partially invested by EU investors and registered in accordance with Chinese law within China are referred to as EU-invested enterprises in China. Medical devices produced by these enterprises in China are not subject to the restrictions of the measures.
5. How should the statement "these measures do not apply to procurement projects where only medical devices imported from the EU can meet the procurement needs" in the Notice be understood? Does it refer to sole-source procurement? Does the procurement entity need to provide technical justification and expert opinions?
A: The statement "these measures do not apply to procurement projects where only medical devices imported from the EU can meet the procurement needs" is not limited to cases of sole-source procurement. For example, if two or more suppliers provide medical devices that meet the procurement needs, but all are imported from the EU.
If only medical devices imported from the EU can meet the procurement needs, and neither medical devices produced domestically nor medical devices imported from other countries can replace them, then the procurement project may procure medical devices imported from the EU to meet the patients' treatment needs. However, the procurement entity shall organize professionals to conduct a review on the necessity of procuring medical devices imported from the EU and submit relevant materials when applying for the procurement of imported products.
6. Does the Notice apply to the procurement of medicines and medical consumables?
A: The measures specified in the Notice apply to products within the scope of the specific item list in the attachment. However, the centralized procurement of medicines and medical consumables organized by the medical insurance department according to current regulations is excluded.
7. Are the specific item lists in the attachment clearly categorized?
A: The content covered by each category in the specific item list can be referenced in the explanations of the corresponding item names in the "Government Procurement Item Classification Directory (issued in 2022)."
8. Currently, an import product review management mechanism is implemented in government procurement activities. Please indicate whether the Notice overlaps with the existing mechanism. If the product has passed the import review by the financial department, but it originates from the EU, is it still subject to the restrictions of the Notice?
A: According to the provisions of the Notice, when the procurement entity purchases medical devices with a budget amount exceeding RMB 45 million and it is indeed necessary to purchase imported products, after fulfilling the legal procedures such as the import product review, the provisions of the Notice shall be implemented.
9. Does the Notice apply to procurement activities of state-owned enterprises?
A: Procurement by state-owned enterprises does not fall under the scope of government procurement. Therefore, the Notice does not apply to procurement by state-owned enterprises.
10. After the implementation of the Notice, how will the financial departments at all levels carry out supervision? Do enterprises have channels for appeals or exception application procedures?
A: Financial departments at all levels will work with relevant departments to supervise the implementation of the Notice. If suppliers believe that there are violations of the provisions of the Notice in specific procurement projects, they may legally raise doubts or complaints to the financial departments.
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