High end medical devices are being "localized" to reduce the burden of patients

Source: Morning Post 2017-11-07 morning, November 7th, the news of China's high-end medical devices is awesome enough, so people will have to use expensive medical devices That may be changing The launch ceremony of the first "medical device quality and safety publicity week" hosted by Shanghai food and Drug Administration and organized by Shanghai Medical Device Industry Association was held yesterday The localization of high-end medical devices means that patients will have a large margin of preferential price when using products with the same performance compared with foreign brands It also provides safe, effective and cost-effective high-end products and high-quality services for Chinese clinicians to treat more patients in need For example, the ultrasonic hemostasis knife product that is about to be launched by Yisi medical is an innovative product developed under the background that the international giant monopolizes about 95% of the global market The original imported products are disposable consumables, and the operation cost is 7000-8000 yuan After the domestic products are put into use, the operation cost can be reduced by half or even more, and the core technical indicators of the products are better than the imported products Not only that, but also hope to take the lead in launching reusable products in the world, further reducing the cost of operation to 2000 yuan The price of high-end medical devices has been reduced, and the range of people who can use them has been expanded, which helps to reduce the operation time and bring benefits to patients At present, Shanghai food and drug administration has identified five enterprises, namely, Shanghai minimally invasive medical device (Group) Co., Ltd., Shanghai Lianying Medical Technology Co., Ltd., Shanghai kantlai Enterprise Development Group Co., Ltd., Shanghai Fosun Long March Medical Science Co., Ltd and Shanghai Shucheng denture Co., Ltd., as implant intervention, active device, polymer aseptic product and diagnostic test The first batch of training bases for five representative products, such as agents and dentistry, was awarded the nameplate of "training base for medical device inspectors of Shanghai food and Drug Administration" After two years of practical training and exploration, more than 200 full-time and part-time production inspectors of medical devices in the city have received multiple rounds of training, basically forming a echelon of senior, intermediate and junior inspectors, undertaking the tasks of daily supervision and inspection, full-time inspection, flight inspection and tracking inspection, and having the ability to deal with and analyze complex professional problems It is reported that since the country opened the green channel for innovative medical devices for more than three years, 26 medical device products in Shanghai have entered the special approval process for innovative medical devices, accounting for nearly one fifth of the total number of medical devices in the country Now four products have successfully obtained medical device registration certificates, not only ranking the first echelon of the largest number of innovative medical device projects in the country, but also ranking at the top of the growth rate in the country ■ during the publicity week of medical device quality and safety, Shanghai food and Drug Administration introduced medical device related knowledge What is medical device adverse event? It refers to all kinds of harmful events that occur under normal use of medical devices that have been registered or have been put on record and have qualified quality and may cause human injury According to the harm degree and causes of adverse events of medical devices, when necessary, the medical device manufacturer shall take such control measures as warning, inspection, repair, re labeling, modification of instructions, software upgrading, replacement, recovery, destruction, etc At present, the monitoring of adverse events of medical devices in China collects reports according to the principle of "suspicious reporting", that is, suspicious adverse events of medical devices Are all medical devices approved for listing absolutely safe? No Any medical device product has certain use risk All of them may have some risks in the clinical application because of the restriction of scientific and technological level and experimental conditions at that time The so-called approval for listing refers to the recognition on the basis of social, technical, ethical and legal acceptability, rather than absolute safety The approved medical devices are only "risk acceptable" products with "benefit greater than risk", that is to say, the approved products are relatively in line with the requirements of safe use at the current level of understanding.