Ordered by the Department of Finance: further restrictions on the procurement of imported equipment!

On November 8, Xianyang City Finance Bureau issued the Notice on Further standardizing the Management of Imported Products Purchased by the Government.

The Notice again emphasizes:
Government procurement shall purchase domestic products, and if it is necessary to purchase imported products, it shall implement audit management.

For the review of imported product procurement projects, the Notice issued specific review steps and requirements.
First of all, the purchaser should strictly control the procurement of imported products, in accordance with the provisions of the “Government procurement demand Management Measures”, the procurement of imported products to carry out demand investigations.
Domestic products that can meet actual usage needs are not allowed to purchase imported products. If it is indeed necessary to purchase imported products, the purchaser should demonstrate the necessity and irreplaceability of purchasing imported products, as well as the substantial impact of purchasing domestically produced similar products on the work.

Secondly, industry regulatory authorities need to conduct a focused review of projects applying for the purchase of imported products. Finally, financial departments at all levels will make full use of the big data analysis information on the Shaanxi Provincial Government Procurement Network to conduct big data supervision and early warning, and strengthen the supervision of imported product procurement.

Any illegal or irregular procurement of imported products by purchasers who set high standards for procurement requirements, raise product purchase standards, fail to follow procurement procedures in a standardized manner, or have unclear review opinions shall be dealt with strictly in accordance with the law and regulations.

Under the new regulations, what changes will be made to the admission threshold for imported medical devices?
The “expert” argument that imports are superior to domestic production is completely dead

• According to the requirements of the Notice, the government procurement of imported products includes the following materials and steps
• 1.he official application document submitted by the purchaser to the municipal financial department.
• 2. Application form for purchasing imported products.
• Approval form for purchasing imported products
• 4 Opinions of industry authorities.
• 5. Expert argumentation opinions.

After submitting the materials, the financial department will issue an audit opinion within 3 working days.

It should be noted that when the municipal financial department approves the government procurement of imported products, it only indicates that the imported products are allowed to participate in the government procurement activities of the project, such as because of information asymmetry and other reasons, there are still domestic products that meet the demand to participate in the procurement competition, no unit or individual may restrict it. And the purchaser and the government procurement agency shall clearly specify this provision in the procurement documents.

In addition, in the process of expert demonstration, strict provisions have also been made:

Panelists
It should be composed of more than 5 people, including 1 legal expert, and the product technical expert should be an expert familiar with the product and should have the intermediate or above technical title of the relevant professional related to the product to be purchased.

Expert opinion
It must be clear whether the project to be demonstrated meets the specific circumstances specified in Article 1 of this notice, that is, the imported products applied for procurement must meet three requirements:
• Those that cannot be obtained within the territory of China or on reasonable commercial terms;
• Purchasing for use outside China;
• As otherwise provided by other laws and regulations.

Expert conclusion
It is necessary to give clear opinions such as “must purchase the imported product or can only purchase the imported product”.

Experts who issue false argumentation opinions are no longer simple administrative penalties, verbal warnings, etc., and will be investigated for legal responsibility in accordance with relevant laws and regulations. This point has been deeply reflected in the management of imported products purchased by provincial governments.

This also means that the simple “imported products are obviously better than domestic” “expert argument” in the past import procurement argument is completely impractical, and domestic equipment can meet the need to prioritize domestic procurement.

More province to promote! Medical equipment import “restrictions” to upgrade
Since the beginning of this year, Shandong, Zhejiang, Guizhou and other provinces and cities are strengthening the audit of the purchase of imported products, and the audit requirements and procedures are increasingly refined and strict.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source ：Medical Device Distributors Alliance
Translated & edited： Bradyknown