Recently, the administration's from yinchuan have learned, in order to further strengthen the local medical equipment supervision, to regulate the denture class medical devices, effective management to crack down on illegal use of constant system denture behavior, and ensure that the people use machinery is safe and effective, according to the state food and drug administration office set about to carry out institutional denture production use supervision and inspection of the notice "and" the food and drug administration shall carry out supervision and inspection system denture production use implementation plan "requirement, yinchuan, the administration's food in the January to march period in constant system denture and medical equipment special treatment. Firmly will not qualified products to clear out the market, to ensure that the legitimate rights and interests of the masses.
It is understood that the special regulation will be from the following five aspects: one is the key control system, the enterprise must establish management system shall include the product purchase, storage, display, maintenance, use, traceability links such as the clear and specific requirements, accomplish system on the wall; The second is strictly purchases, from purchase channels, for retained qualification, acceptance and other links made specification requirements; The third is classified storage, store display medical equipment according to the classification put, a color code management; The fourth is the standard is used, the use of constant system denture instrument must establish accurate and complete records, use the denture production enterprise product quality warranty card issued by the delivery of the patients; Five is to perfect the trace, the establishment of use files, including denture production enterprise custom list, with batch number's set system denture product label or instructions, etc., to ensure that the product traceability.
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