- 15-05-13常用低价药取消最高零售限价 医疗机构须网上采购
- 15-05-13Classify the regulation of medical equipment by risking.
- 15-05-13医疗器械企业 质量信用将分级
- 15-05-12医疗器械企业 质量信用将分级
Medical equipment, Small to a spatula, a transfusion needle , big to a nuclear magnetic resonance instrument. To make all of these medical devices control , the difficulty can be imagined.
Reporters learnt from Beijing municipal food and drug administration , the newly revised requlations on the supervision and administration of medical devices will be officially announced on June 1st this year. Beijing will be based on the classification management and risk ,” pressure”to risky products company, “decoupling” the low risk company. Promote the healthy development of medical equipment company.
At present the city has a total of 1277 medical device production company, 13764 medical device operation company. The same medical equipment company has a huge difference of the risk.FSDA now has introduced classification regulation of product company, classify four grades, according to the high risk, warning , attention ,conventional .more than 10000 medical equipment company are”more, small,scattered” FSDA for orthopedic products, implanted heart intervention, in vitro diagnostic reagents, such as five types of high-risk medical devices lauched pilot medical apparatus and instruments of third party logistic, to determine 7 medical equipment company as third party logistic, through the supply chain manage product and consummating the system of medical equipment storage and transporation.
Since April this year, the city has took thousands of medical equipment company ,contacts ,hearing aid out of the market, which are centralized management, inspected the company who sell medical equipment by the consumer experience stores and plant in operation of high –risk products.