The supervision of imported equipment into hospitals upgraded!
Recently, the Guangdong Provincial Department of Finance issued the List of Common Problems in Government Procurement (hereinafter referred to as the List), listing 64 types of prohibited situations in government procurement activities, and a number of restrictions on domestic and illegal procurement of imported equipment are also included.
The 19th category, item 61 of the List requires: “Authorization, commitment, certification, endorsement, etc. of manufacturers other than imported goods are prohibited as qualification and compliance requirements.
That is to say, in the medical device bidding and procurement activities, the establishment of some manufacturers’ authorization, commitment, certification, endorsement and other unreasonable bidding standards for domestic products as qualification requirements and compliance requirements is strictly prohibited.
Article 196 of Category 52 explicitly prohibits: “Experts who participate in the demonstration of imported products shall also participate in the procurement review of the project.”
also restrictio on the procurement of imported equipment in category 7 of the List: “It is prohibited to procure goods and services above 10 million yuan, and engineering procurement projects above 30 million yuan, without carrying out a survey of needs”.
As we all know, large medical devices with a unit price of 10-30 million yuan are temporarily listed as Class B equipment. In other words, when public hospitals purchase Class B equipment, or need to purchase imported medical equipment, they must carry out a demand survey, otherwise it is considered that the project is not compliant.
Another way has also been widely used by provinces to restrict the purchase of imported medical equipment, that is: import audit.
At the beginning of this year, the Shenzhen Municipal Finance Bureau issued the Shenzhen 2023-2024 Government Centralized Procurement Catalog and Quota Standard. At the The document stressed that government procurement should purchase domestic goods, projects and services, and if it is necessary to purchase imported products, the purchaser should strictly implement the audit procedure in accordance with relevant provisions.
Specifically in the area of medical devices, the procurement of imported medical equipment by public healthcare institutions will be uniformly subject to expert validation and preliminary examination by the competent sectoral authorities (i.e. urban healthcare authorities).
The import product audit management process is divided into three steps:
1．The purchaser submits an application for purchasing imported products;
- The competent budget unit or the competent industry department shall organize expert demonstration and preliminary review;
- The financial department or the development and reform department shall conduct the final review.
If the purchaser intends to purchase imported products, it must also carry out a demand survey in advance, and then fill in the Application Form for Government Procurement of Imported Products.
In other words, the “import is better than domestic” in the previous import procurement argument is completely impractical, if domestic equipment can meet, and domestic procurement must be prioritized.
It is more important to form a preliminary review opinion based on the purchaser’s reasons for applying for the procurement of imported products, the situation of imported products that have been procured, the number of imported products procured in the current year and its percentage, as well as the full-life-cycle costs involved in the imported products, in conjunction with the expert’s argumentation. Not only should they be fully justified, but they should also be combined with actual data, otherwise they will also fail to pass the audit!
Multiple provinces are launching comprehensive investigations!
In these cases, the application for procurement of imports is invalid and returned
Not only Guangdong Province, since last year, from the state to the local, there is no emphasis on the import product procurement audit, and the audit requirements and procedures are becoming more detailed and accurate. Not only Guangdong Province, but since last year, there has been an emphasis on the procurement audit of imported products from the national to local levels, and the audit requirements and procedures in various regions have become increasingly refined and precise.
For example, the Ningxia Autonomous Region clearly states that the reasons for applying for the purchase of imported products should 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.
Anhui Province has made it clear that the procurement of imported medical equipment by public hospitals will be reviewed, which focuses on the review of experts on the project procurement needs of the argumentation If the argumentation opinions are not specific or clear, they will not be able to pass the review.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.
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 ： Bradyknow
