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Official documents from many places: Strictly check imported medical devices and establish a list

2021-07-19

A few days ago, the China Government Procurement Network published the "Experts' Demonstration Opinions on the Purchase of Transcranial Doppler and Other Medical Equipment Projects by Hubei Provincial Hospital of Traditional Chinese Medicine" (hereinafter referred to as "Opinions").

According to the "Opinions", Hubei Provincial Hospital of Traditional Chinese Medicine will purchase 12 imported products including transcranial Doppler, extracorporeal circulation machine, intra-aortic balloon pump and anesthesia machine. The budget amount is RMB 29.03 million. The expert opinion mainly believes that the imported products purchased in this batch are superior to domestic products in terms of accuracy, convenience, operability, and functionality.

It is reported that the experts of Hubei Provincial Hospital of Traditional Chinese Medicine on imported products this time consisted of 1 Chief Technician from Armed Police Hospital, 1 Associate Professor of Medical Engineering at Hanjiang University, 1 Chief of Wuhan Fifth Hospital, 1 Deputy Senior Officer of Xiangyang Stomatological Hospital, and 1 Wuhan Railway Vocational and Technical College is composed of associate professors of law.

According to the "Administrative Measures for Government Procurement of Imported Products", state agencies, institutions, and organizations must use financial funds to purchase imported products (including imported products that have entered China) through direct import or entrusted methods, and they must conduct expert evaluation in accordance with established procedures. Report to the record level by level, and then implement the procurement.

It can be seen that the implementation of expert opinions is one of the important basis for purchasing imported medical devices.

01

Precautions for expert demonstration of imported medical devices

According to the "Administrative Measures on Government Procurement of Imported Products", imported products refer to products that have passed China's customs declaration, inspection and release into China and are produced outside the customs. Where the government really needs to purchase imported products, audit management shall be implemented.

At present, in addition to the equipment that is clearly stipulated in the national laws, regulations and policies to encourage import, the procurement of imported medical equipment should be submitted to the financial department for review, and the "application form for government procurement of imported products" and "municipal budget unit government procurement of imported products review should also be issued. "Form", "Opinions of the Industry Competent Department of Government Procurement Import Products" and "Expert Demonstration Opinions of Government Procurement Import Products". Among them, the "Government Procurement of Imported Products Expert Demonstration Opinion" is one of the more important links.

According to the regulations, the expert group forming the "Expert Demonstration Opinions on Government Procurement Imported Products" shall consist of an odd number of five or more members, and must include a legal expert. Product technical experts should be experts who are not the unit and familiar with the product, and representatives of the purchaser shall not participate in the demonstration as members of the expert group. In addition, experts participating in the demonstration shall not participate in the procurement review of the same project as procurement review experts.

Experts should fully consider the development status of the industry to which the product belongs. Although it is necessary to consider meeting the requirements of "purchasing domestic goods" on the basis of business needs, it is also necessary to take into account the characteristics of the project to which the product belongs, and make judgments based on the purpose or direction of use of the product. The argumentation opinions issued by the expert group for purchasing imported products should include: 1. Know the actual needs of users; 2. Determine whether there are substitutes for domestic products; 3. Compare technical parameters to clarify the reasons why domestic products cannot meet actual needs; 4. Check whether there are import and export restrictions, propose solutions, etc.; 5. Lawyers' opinions at the legal level.

It should be noted that experts argue whether imported products are irreplaceable. Once similar products exist in China, even if they are slightly inferior in quality or technology, domestic products may receive more support and have certain advantages over imported products entering the market.

02

Standardized procurement of imported medical devices

As a result of the problems of random mashup of expert groups during the actual operation of the expert demonstration work. In recent years, Zhejiang, Guangdong, Dalian, Shaanxi and other places have successively made some institutional innovations and improvements, such as trying to study and formulate a list of government procurement imported products to promote more reasonable and standardized procurement of imported medical equipment.

The financial department and relevant units shall jointly study and formulate a list of imported products that cannot be replaced by domestic products in their respective fields and must be purchased. Once determined, it will be valid for a certain period of time. For all the products on the list, there is no need to organize an expert demonstration by the purchasing unit. In this way, it not only simplifies the government procurement work process, but also improves work efficiency, and also enhances the level of innovation in government procurement.

The Zhejiang Provincial Department of Finance announced the "2021-2022 Provincial Government Procurement of Imported Products Unified Demonstration List (Medical Equipment)". There are 195 types of medical equipment included in the Zhejiang Provincial Government's Unified Demonstration List of Imported Products Procured. The Guangdong Provincial Health Commission issued the "Announcement on the List of Imported Products of Provincial Health Institutions in 2021", showing that 46 types of equipment are listed in the product list, through list management and simplified procedures, so as to improve the efficiency of government procurement of imported products. Sichuan Province has formed a unified demonstration list of imported products for the period 2021-2022, showing that a total of 59 types of medical equipment can be purchased and imported.

Although many national departments have issued documents requiring medical institutions to give priority to the use of domestic medical equipment under the same conditions, imported instruments are still very popular in the domestic market. Many large hospitals, universities, scientific research institutes, national, provincial and ministerial-level testing institutions In the laboratory, imported equipment is also preferred. The establishment of the list of imported medical equipment products will help further strengthen the management of government procurement of imported products, and also improve the efficiency of imported products review. For imported medical equipment, there will be a new situation where the strong will become stronger.


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