Fourteenth National Medical Device Quality Bulletin issued
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In June 21st, the State Food and Drug Administration issued fourteenth year period of national medical devices Quality Bulletin of disposable tracheal intubation, medical electronic thermometer, elastomeric impression materials of 3 varieties of 247 batch (Taiwan) product quality supervision and sampling results to be published. Among them, 92 medical device manufacturers of 3 varieties, 241 batch (Taiwan) products were sampling items, all in line with standard requirements. The sampling project does not meet the standard requirements of products involving 3 types of 4 medical equipment manufacturing enterprises in 4 batches (Taiwan); sampling to identify the labels and instructions and other projects do not meet the standard requirements of medical products, involving 1 types of 2 medical equipment manufacturing enterprises 2.
Announcement shows that the sampling project does not meet the prescribed standards of 3 varieties of 4 batch (Taiwan) products specifically: 1 digital electronic temperature Dongguan Xiehe Medical Appliance Technology Limited production, the maximum permissible error does not meet the standard requirements; the 1 batch of tracheal intubation in Henan YADU Industrial Co., Ltd., Henan Province Jian Qi medical instrument limited company to produce, the cuff (full diameter) does not meet the standard requirements; the 1 batch of elastomeric impression materials Shandong Shanghai pigeon dental materials produced by Limited by Share Ltd, the work time does not meet the standard requirements.
By sampling to identify the labels and instructions and other projects do not meet the standards of the 1 varieties of 2 products in particular: Bao Ruiyuan Biotechnology (Beijing) 1 Taiwan electronic thermometer 1 medical electronic temperature limited production plan, Yiwu Braun Medical Equipment Co. Ltd production plan, marking its external equipment or equipment parts not meeting the prescribed standards.
In view of the above sampling found in the product does not meet the standards, the General Administration has asked the local food and drug supervision departments to investigate and deal with the relevant enterprises.