Medical network - on November 21, a few days ago, hubei province food and drug administration issued a "about medical equipment management enterprise in our province cross check the bulletin, examined 117 medical device operation enterprises, 74 of which are problems, by varying degrees of punishment.
It is worth noting that in 75 problem YiXie business enterprises, there are as many as 23 was asked directly closed corrective, followed by the further or four check verification and other 47 were ordered to make correction.
According to report, the inspection found that the main problems include:
1, make operating medical equipment. Individual retail pharmacies in 2 kinds of sales class ii medical device registration certificate.
2, do STH without authorization changes license (registration). Unauthorised changes to the individual enterprise name, address, warehouse reduce business area, or even cancel warehouse, product storage conditions have different degrees of change of business.
3, quality management personnel failed to conscientious. Part of the enterprise quality management personnel are not familiar with the supervision and administration of medical devices regulations, rules, do not take the laws and regulations training; Part of upstream and downstream enterprises collect qualification is not complete, can't provide the quality assurance agreement, legal person accredit a power of attorney, medical equipment inspection report, etc.
4, suitable conditions do not conform to the requirements. Individual enterprise warehouse management chaos, partition storage products not according to requirements, the quality management system is not effective implementation; Need low temperature, cold storage of medical equipment for the whole chain of cold chain management, some enterprises cold-chain transport interchange receipt, transit temperature records; Part of the enterprise is not in accordance with the requirements for medical equipment manual and label transportation and storage of medical equipment, warehouse temperature and humidity record is not complete.
Notification requirements, secri food drug administration to jurisdiction quality management problems of the medical equipment management enterprise in accordance with the rules for processing in accordance with the law, for serious violation behavior to initiate an investigation, until revoked medical equipment business licenses. Follow the rectification of the enterprise to carry out the inspection at the same time, and the enterprise reformed and case investigation situation report on December 2, 2016 in hubei province.
Hubei province medical equipment management enterprise cross check found the problems of enterprises and processing sheet: |
