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四川将全面打击无证医疗器械 宾馆、美容院为重点

2017-08-23 14:07:00   中国经济网

经济日报-中国经济网北京8月23日讯 (记者 吴晓薇)记者从四川省食品药品监督管理局获悉,为了稳步推进医疗器械监管工作,切实保障群众用械安全有效,四川省食药局决定今年下半年在全省范围内开展打击无证生产经营医疗器械与生产经营和使用无证医疗器械专项检查工作。

四川省食药局将对监督企业严格按医疗器械相关法规要求开展生产经营活动,进一步规范医疗器械生产经营和使用行为。具体检查内容有:

1、在生产环节,要严查未经许可生产第二类、第三类医疗器械的行为。重点检查无菌植入性医疗器械生产企业。

2、在经营环节,要严查未经许可或备案从事医疗器械经营活动、经营未取得医疗器械注册证或备案凭证医疗器械和进口销售翻新医疗设备的违法行为。重点检查宾馆、小商品交易市场。

3、在使用环节,要严查采购和验收,查处使用单位使用无证产品,特别是使用无证大型设备与耗材的行为。重点检查大型医疗机构及美容院。

本次检查工作将从8月开始,各市州局要积极组织企业召开动员会,企业全面开展自查工作,并将自查结果和自查整改报告报送辖区市(州)食品药品监管部门。9月下旬-10月底开始集中检查。

四川省食药局表示,在检查中发现无证生产经营医疗器械与生产经营和使用无证医疗器械的单位,严格依法查处,重大案情及时上报省局。省局将根据工作安排组织督查组对各市(州)局专项检查工作开展情况进行抽查。力争通过此次专项检查,监督企业严格按医疗器械相关法规要求开展生产经营活动,进一步规范医疗器械生产经营和使用行为,确保群众用械安全有效。

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