Medical network - December 2, recently, the anhui province food and drug administration issued the implementing rules for the supervision and administration of medical devices management way in anhui province (hereinafter referred to as detailed rules), and refine the medical equipment management regulation.
It is reported, current medical equipment management enterprise in anhui province in 6252. The enterprise overall in small scale, quantity, wide distribution and regulation is difficult, there are some potential safety hazard. Detailed rules to quantify the hardware condition of medical equipment management enterprise. Engaged in the management of the third class medical equipment wholesale, premises shall not be less than 100 square meters, construction area according to the warehouse management of medical equipment specific category is different, need to reach 200, 80, 60 square meters respectively three levels. Detailed rules on the management need to cold chain storage of medical apparatus and instruments to make strict rules, require cold storage should be equipped with automatic monitoring, control, display and record the temperature conditions and automatic alarm facilities, should be adapted to business scale and business varieties, to meet the requirements of product features such as storage temperature refrigerator car or can be displayed automatically temperature cooler, can implement the whole monitoring.
In addition, companies engaged in the management of class iii medical devices shall also be adapted with the business scope and scale of operation of the computer information management system, can real time control and record the whole process of medical equipment management and quality management of each link, ensure that the products traceability. Once found the problem, can recall in time, minimize potential safety hazard.
According to the regulation, the enterprise engaged in the second category of medical equipment management, should be in accordance with the law to the food and drug regulatory authorities for the record. "Detailed rules" regulation, the food and drug regulators cannot "case regardless," on the record companies must strict supervision, within 3 months from the date of filing, must according to the medical equipment management and the quality control standard to carry out the on-site verification. |
