High-end medical devices are undergoing 'localization' | Reduced patient burden

Pharmaceutical Network November 7 News Domestic high-end medical equipment is not enough to force, resulting in people have to use expensive imported medical equipment ...... This may be changing .Shanghai Food and Drug Administration by the Shanghai Medical Device Industry Association The first medical device quality and safety publicity week was held yesterday, and the launching ceremony was held yesterday.The localization of high-end medical devices means that patients will have more favorable concessions in using the products with the same performance as foreign counterparts, and will also provide more treatment to Chinese clinicians More patients need to provide safe, effective and cost-effective high-end products and services throughout the quality.

For example, Essence Medical upcoming immortalized bleeding knife products, the international monopoly exclusive monopoly around 95% of the global market to develop innovative products under the original imported products is a one-time consumables, the cost of surgery at 7000-8000 yuan, And domestic products put into use, you can reduce the cost of surgery by half or more, and the core technical indicators of products than imported products.Not only that, but also expected to launch the world's first reusable products, the cost of using the surgery to further reduce To 2000 yuan.

The price of high-end medical devices has been reduced, the range of people that can be used has been expanded, helping to reduce the operation time and bring good news to the patients.

At present, Shanghai Food and Drug Administration established the Shanghai minimally invasive medical equipment (Group) Co., Ltd., Shanghai United Film and Television Medical Technology Co., Ltd., Shanghai Kandlai Enterprise Development Group Co., Ltd., Shanghai Fosun Changzheng Medical Science Co., Ltd. and Shanghai Speed Denture Co., Ltd. five companies, as the implantation of interventional class, active equipment, polymer sterile products, diagnostic reagents and dental Dental and other five representative products of the first training base and awarded the ' Shanghai food drug Supervisory Authority medical instruments Inspector training base 'nameplate.

After two years of practical training to explore, the city has more than 200 Famous doctor Medical device part-time production inspector received a number of rounds of training, the basic formation of senior, mid-level and primary inspector echelon construction, daily maintenance supervision, inspection, flight inspection and follow-up inspection tasks, with complex professional issues handling and analysis Ability.

According to reports, since the country opened the green channel for innovative medical devices more than three years ago, Shanghai has 26 medical device products to enter the special approval procedures for innovative medical devices, accounting for nearly one-fifth of the total number of the country, now 4 products have been successfully Access to medical equipment registration card, not only ranked the country's most innovative medical equipment projects the first echelon, the growth rate among the best in the country.

Medical Device Quality and Safety Publicity Week, Shanghai Food and Drug Administration introduced a small medical device-related knowledge.

Refers to the registration or has been registered, the quality of qualified medical devices, under normal use, resulting in or may cause a variety of harmful events.

According to the degree of harm of the adverse events of medical devices and the reasons for their occurrence, medical devices are produced enterprise Necessary, take warning, inspection, repair, re-label, modify the instructions, software upgrades, replacement, recovery, destruction and other control measures.

At present, the surveillance of adverse events in medical devices in China collects reports in accordance with the principle of "suspicious reporting", which is the report of adverse events of suspicious medical devices.

No, any medical device product has a certain risk of being used, which may be at risk in the clinical application process due to factors such as the restriction of the scientific and technological level at that time and the restriction of experimental conditions, etc. The so-called approval of the listing refers to the social, technical, Ethics and laws are acceptable, but not absolute security.Medical devices approved for listing are only 'risk-acceptable' products that are more effective than risk, that is, the products that are approved to be marketed under the current level of understanding, Meet the requirements of safe use.