Medical network on December 20 - on December 19, the reporter learns from the shaanxi provincial food and drug supervision bureau, our province has introduced a hierarchical classification of medical device manufacturing enterprise in Shanxi Province "regulatory detailed rules, clear since January 1, 2017, if there are any suspected serious violation of medical device manufacturing enterprise or major quality accidents which happen in nearly two years of 7 kinds of circumstances, the provincial or municipal food drug administration should be timely inspection on enterprise group.
It is understood that the classification of the "rules" in a clear hierarchical management, refers to the degree of risk according to the medical apparatus and instruments, the quality of the medical device manufacturing enterprise management level, combined with other factors, the medical device manufacturing enterprise can be divided into different levels, and in accordance with the principle of territorial supervision, implementation of hierarchical dynamic management activities. Supervision on medical device manufacturing enterprise can be divided into four levels. Among them, the four regulation is on the catalog of national key regulatory medical equipment involved in the production of the enterprise quality management system operation condition, poor credit rating, there is a big product quality and safety hidden trouble of production enterprises to carry out supervision activities.
"Detailed rules" requirement, credit rating to breach the, food and drug supervision and administration department of the enterprise thinks it is necessary to carry out responsibility questioning other circumstances of 4 kinds of circumstances, such as a drug regulators can be for enterprise's legal representative or chief responsible for questioning. Companies suspected of serious violation, the major quality accidents which happen in nearly two years, the state administration of quality supervision to sample products are unqualified important quality index of 7 kinds of circumstances, the ShengJu or city bureau shall organize flight check in time, the production and quality management system of enterprise conduct site inspection. |
