近日国家食品药品监管总局公布了2016年第3期国家医疗器械质量公告,对医用外科口罩、医用电子体温计、金属接骨螺钉等8个品种299批(台)产品的质量监督抽验情况进行了公告。其中被抽验项目不符合标准规定的医疗器械产品,涉及20家医疗器械生产企业的8个品种32批(台);被抽验项目为标识标签、说明书等项目不符合标准规定的医疗器械产品,涉及4家医疗器械生产企业的3个品种5批(台);抽验项目全部符合标准规定的医疗器械产品涉及142家医疗器械生产企业的6个品种263批(台)。
目前国家食品药品监管总局已要求不符合标准规定产品企业所在地食品药品监督管理部门对相关企业进行调查处理。并要求相关省级食品药品监督管理部门及时将处置情况向社会公布。
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