Finance Bureau: Further restrict the purchase of imported medical equipment!

At the beginning of this year, the Shenzhen Municipal Finance Bureau issued the Shenzhen 2023-2024 Government Centralized Procurement Catalog and Quota Standard(hereinafter referred to as the Procurement Catalog).

The new version of the Procurement Catalogue emphasizes that government procurement shall purchase domestic goods, projects and services. If it is necessary to purchase imported products, the purchaser shall strictly perform the examination procedures in accordance with the relevant provisions.

Specific to the field of medical devices, the procurement of imported medical equipment by public medical and health institutions will be unified by the industry authorities (that is, the urban health authorities) for expert demonstration and preliminary audit.

The import product audit management process is divided into three steps:

①The purchaser applies for purchasing imported products

② The competent budget unit or the competent department of the industry shall organize experts’ demonstration and preliminary review

③ The financial department or the development and reform department shall conduct the final examination

If the purchaser intends to purchase imported products, he must carry out a demand survey in advance, and then fill in the Application Form for Government Procurement of Imported Products.  It is worth mentioning that the application form must be detailed in terms of the necessity of imported products, irreplaceability, and the substantial impact of purchasing similar domestic products on the work.

In other words, the “import is better than domestic” in the previous import procurement argument is completely impractical, and domestic equipment can meet, and domestic procurement must be prioritized.

In addition, the competent budget unit or the competent department of the industry will also put forward preliminary audit opinions based on the reasons for the purchase of imported products proposed by the purchaser, the situation of imported products that have been purchased, the quantity and proportion of imported products purchased this year, and the whole life cycle cost of imported products involved, combined with expert argumentation opinions.

The key basis of the audit also includes: the superior department and the city’s policy documents on government procurement of imported products; Whether there is over-standard procurement, whether the procurement needs are reasonable, and whether domestic similar products can meet the work needs.

Nationwide landing! Approval required for purchasing imported medical equipment

In fact, since last year, there has been an emphasis on the procurement review of imported products from the national to local levels.

As early as the beginning of last year, the Ministry of Finance reviewed and adopted the Interim Measures for the Management of Procurement Methods under the Framework Agreement on Government Procurement, emphasizing that when purchasing imported medical equipment and testing instruments, they need to be approved.

Then, the finance departments of all provinces in the country have been opening  a comprehensive investigation into the purchase of imported products.

In April 22, the Anhui Provincial Department of Finance and other three ministries issued the Notice on Matters Related to Regulating the Government Procurement of Imported Products by Public Medical Institutions, making it clear that public medical institutions need to strictly review the procurement of imported products.

In June 22, the Hubei Provincial Department of Finance issued the Hubei Provincial Government Procurement Work Regulations, which clarifies that the project of purchasing imported products must carry out demand investigation.

Then in September 22, the Ningxia Department of Finance issued the Notice on Matters related to the optimization of the purchase management of imported products at the Autonomous Region level, the audit of purchased imported products is more stringent, and the imported products that the purchaser intends to purchase shall organize experts to demonstrate the necessity.

In February this year, the Tibet Department of Finance issued the Catalogue of Government Centralized Procurement and Procurement Quota Standards for 2023-2024 of the Tibet Autonomous Region, making it clear that imported products can be purchased only if they are approved by the financial department before procurement activities.

For example, the Ningxia Autonomous Region clearly states that the reasons for applying for the purchase of imported products shall include the procurement demand, the technical indicators and performance description of imported products and similar domestic products, and the comparison of technical indicators and performance of imported products and domestic products.

Tianjin points out that expert argumentation opinions only use descriptive language such as “better”, “higher” or “good” and “bad” without elaborating specific differences or ambiguous argumentation opinions are invalid opinions.

It is also clear that the procurement of imported products in the case of incomplete internal control procedures, unclear expert arguments, incomplete information, and unclear review opinions of the competent authorities will be returned or not approved in a timely manner.

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 Distrbution Alliance

Translated & edited ： Bradyknows