Limit the purchase of imported equipment Domestic high-end equipment still need to break through!

to strictly audit the import ofFebruary 1, Shanghai Yichao Medical Devices Co., Ltd. ultrasonic soft tissue cutting hemostage equipment obtained a registration certificate, the product is currently the first domestic, the world's second ultrasonic energy surgery system with anti-adhesive function.On January 7, Huitai Medical landed on the Science and Technology Board, Huitai Medical is the first domestic manufacturer in China to obtain electrophysiological electrode catheters, controlled radio frequency ablation electrode catheters, floating temporary pacing electrode catheters and enter clinical applications.The first domestic products continue to be born, domestic medical devices are developing rapidly, at the same time, the procurement of imported medical devices is being further restricted, but also indirectly for domestic medical devices to create opportunities.Recently, the Guangdong Provincial Finance Department issued the "Guangdong Provincial Finance Department on the optimization of provincial government procurement of imported products management related matters notice" (hereinafter referred to as "Notice"), clearly requires strict review of government procurement of imported products.According to the Notice, the competent budget unit shall establish and improve the relevant system for the approval and management of government-purchased imported products in its department, strictly implement the requirements of "tight days" and strictly examine government-purchased imported products.For subordinate units applying for the purchase of imported products, they shall focus on auditing whether there is sub-standard procurement, the necessity, irreplaceability, economy and efficiency of the purchase of imported products."Notice" also requires to strengthen after-the-fact supervision, the competent budget unit should strictly approve the government procurement of imported products, strictly manage the department or the system of government procurement of imported products list, strengthen the department's import product procurement activities performance management.Buyers should, in accordance with the principle of "who buys and who is responsible", fully implement the main responsibility, improve the internal control management system, seriously carry out market research and price measurement, and reasonably define the demand for government procurement of imported products.

to purchase imported equipment, the whole process of supervisionThe above-mentioned Notice also shows that the Guangdong Provincial Finance Department will make full use of modern information technology to implement a table of imported products supervision. Comprehensively comb the government procurement of imported products management links, through a table to reflect the units of government procurement of imported products of the basic situation.At the same time, an early warning monitoring mechanism is established to monitor the time, legality and compliance of the purchaser's application for imported products, the reasons for the application, the purchase price and the auditing matters of the competent budget unit.Gradually establish the ratio, statistics and analysis of imported products and domestic products, for buyers to scientifically define procurement needs, domestic product industry development and other aspects to provide reference."Notice" requires that the purchaser intends to purchase imported products, in the report to the competent budget unit for examination, should submit: 1. Government procurement of imported products application form; 2. Government procurement of imported products expert argumentation, as well as the name, work unit and title of the expert; 3. Project budget approval documents or proof of source of funds; 4. If the imported products to be purchased belong to imported products with domestic similar products in China but cannot meet the real needs, a comparative table of domestic similar products and imported products in terms of technical parameters, functional performance, etc., as well as the minutes and records of the meetings and decisions on the "triple one" matters of the unit5. Other materials specified by the competent budget unit.In fact, as early as August 24, 2020, the Guangdong Provincial Finance Department issued "on the 12th session of the provincial CPPCC No. 20200567 proposal reply letter" shows that the provincial medical institutions will actively promote the possession of large-scale domestic medical equipment.The provisions of the Measures for the Administration of Government Procurement of Imported Products shall be strictly enforced without violating the existing laws. Government procurement shall purchase domestic products, and the products that the purchaser needs to purchase cannot be obtained or obtained under reasonable commercial conditions within the territory of China, and if there are other provisions of laws and regulations that require the purchase of imported products, audit and management shall be exercised.A list of imported products will be established at the provincial level, with experts led by the Provincial Health and Health Commission to demonstrate the parameters of similar products at home and abroad for medical equipment, to formulate a list of imported products for parameters that cannot be reached by domestic products, and to implement dynamic management (after 1 year of re-argument, during which if domestic products meet the requirements, they will be removed from the list).

domestic high-end equipment, still need to break through   According to the analysis of China Industrial Information Network, the global medical device industry is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry, with high barriers, high concentration, is a country's manufacturing industry and high-tech development level of one of the standards.   At present, the United States is the most important market and manufacturing country for medical devices, accounting for about 40% of the global medical device market share. Europe is the world's second largest market and manufacturing region for medical devices, accounting for about 30% of the global medical device market share.   Germany and France are the main manufacturers of medical devices in Europe, France is the second largest manufacturer of medical devices in Europe after Germany, and is also a major exporter of medical devices in Europe.   Japan is an important manufacturer of medical devices in the world, and based on its industrial development foundation, Japan's advantages in the medical device industry are mainly reflected in the field of medical imaging.   According to the Forward-Looking Industry Research Institute, the market size of China's medical device industry exceeded 500 billion yuan in 2018, reaching 525 billion yuan, up 18% year-on-year.   Although the rapid progress of domestic medical devices, but in the field of high-end products still need to make further breakthroughs.   Forward-looking industry research institute analysis, at this stage, China's medical device market basic composition of high-end products accounted for 25%, low-end products accounted for 75%, while the international medical device market medical device products basic composition of high-end products accounted for 55%, low-end products accounted for 45%.   And in China's medical devices accounted for 25% of the high-end products market, 70% by foreign investment occupation, 70% of these foreign-funded enterprises in medical imaging equipment and in-body diagnostics and other areas of high technical barriers, market share of more than 80%, and China's medical device enterprises mainly produce low- and medium-end varieties.   China Industry Information Network also analyzed that the medical device industry's profits are largely from new products (especially exclusive products), and old products because the market too many similar products, too fierce competition, so sometimes manufacturers can only reduce prices to sell to make a living.   New products are different, because the market lack of competition for similar products, innovative medical device products can certainly sell at a good price. That's why the medical device industry needs to invest heavily in new products. (Cypress Blue Device)