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Guangdong Province and the food and Drug Administration deployme
发布时间：[0000-00-00] 点击次数：2207
To enhance the quality of high risk products, medical supervision, further standardizing medical practices, increasing medical institutions use medical devices of law-abiding quality awareness, Guangdong Province, the food and drug administration in conjunction with the recent deployment of own actual, 2008 medical institutions use medical supervision and inspection plan.
Check the program include: the sterile medical device, the implanted material and artificial organs, interventional devices, in vitro blood circulation and processing equipment, third class medical electronic devices such as pacemakers), the third class in the operating room, first-aid room and consulting room equipment and apparatus, such as infant incubator) and other high risk products, medical devices and in vitro diagnostic reagents priority check products; focus product purchase channels is legitimate, do you want to use no product registration certificate, without qualification, expired, or the failure of the medical equipment, purchase of acceptance record is set up, in vitro diagnostic reagents storage conditions necessary to meet the requirements, the implanted medical device use is set up and save the dates of use of record, whether for medical device class to establish a management, calibration, maintenance, and take notes, etc.
Guangdong Province and the food and Drug Administration will be high risk products, to check the origin of in-use medical devices to focus, use strict medical device, be sure to check the work off the acquisitive, jurisdiction over medical institutions within the secondary checks and related records, check coverage is at least 60%. On the issues identified during the inspection ordered corrections, were arrested for illegal issues will timely handover of inspection departments for processing.
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