Our country will implement the medical equipment and recall the system

Our country will implement the medical equipment and recall the system
Our country will implement the medical equipment and recall the system
Www.xinhuanet.com Beijing 9 Special despatch of the 6th of moon (reporter Chen Fei) The State Council legal system office 6 Japan announces <>Stipulate, the country will set up the product retrieving system of medical equipment, the manufacturing enterprise will find the medical equipment does not accord with relevant requirement, should recall immediately. The draft stipulates, the manufacturing enterprise of medical equipment finds its medical equipment produced does not accord with the national standard of the medical equipment, medical equipment products technical requirement, should stop producing immediately, has recalled and has already been listed the medical equipment sold, notify relevant operator and consumer, and record and recall and notify the situation, release relevant information. The draft stipulates, it doesn't accord with the national standard of the medical equipment, medical equipment products technical requirement that the medical equipment manages enterprises and discovers its medical equipment that deals in, should stop management immediately, notify relevantly and produce and manage the enterprise, user and consumer, and record and stop managing and notifying the situation. The manufacturing enterprise of medical equipment thinks that should recall, should recall immediately. The draft still stipulates, the manufacturing enterprise of medical equipment should take measures of remedying, destroying etc. to the medical equipment recalled, and recall the medical equipment and handle the situation to report to food pharmaceuticals administration department. According to the draft, the medical equipment produces and manages enterprises and has not recalled or stopped managing according to the regulation, the food pharmaceuticals administration department can order it to recall or stop management. Meanwhile, the draft requires the medical equipment to produce and manage enterprises and the user and carry on the record in accordance with this regulation, guarantee its medical equipment produced, managed, used can be traced back to; To the planting into medical equipment, should guarantee that can trace back to the patient who plants this medical equipment into.


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