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政策法规 > 关于贯彻落实医疗器械经营企业分类分级监督管理规定和医疗器械经营环节重点监管目录及现场检查重点内容的通知
关于贯彻落实医疗器械经营企业分类分级监督管理规定和医疗器械经营环节重点监管目录及现场检查重点内容的通知
浙江省食品药品监督管理局关于贯彻落实医疗
器械经营企业分类分级监督管理规定和医疗
器械经营环节重点监管目录及现场检查
重点内容的通知
浙食药监规〔2015〕23号
各市市场监督管理局(食品药品监督管理局): 国家食品药品监督管理总局(以下简称“国家总局”)《医疗器械经营企业分类分级监督管理规定》(食药监械监〔2015〕158号)(以下简称《规定》)和《医疗器械经营环节重点监管目录及现场检查重点内容》(食药监械监〔2015〕159号)已翻印下发各地。结合我省实际,现就贯彻落实《规定》和《医疗器械经营环节重点监管目录及现场检查重点内容》的有关事项通知如下。 一、医疗器械经营企业实施分类分级监督管理是提高医疗器械监管科学化水平,落实各级监管责任,提升监管效能,保证公众用械安全的重要举措。各地要广泛宣传、精心组织、制定方案、认真贯彻实施。各市局实施方案请于2016年2月15日前报省局医疗器械监管处。 二、各市局要按《规定》要求,结合医疗器械经营企业日常监管的基本状况,于2016年2月底前完成辖区医疗器械经营企业的分类分级,并按分类分级要求落实监管措施。辖区经营企业分类分级情况及相关信息请各市局在2016年2月底前录入浙江政务服务网行政权力运行系统(省局)医疗器械经营企业分类分级监督管理数据库。医疗器械经营企业分类分级信息由省局统一向社会公布。今后,医疗器械经营企业新增、注销或变更的,企业分类分级信息实时生成、即时公开。 三、各地应根据《规定》和《医疗器械经营环节重点监管目录及现场检查重点内容》的要求,科学制定医疗器械经营监管计划,通过全项目检查、飞行检查、跟踪检查和监督抽验等形式强化监督管理。自2016年7月1日起,医疗器械经营企业监督检查的结果,在浙江政务服务网行政权力运行系统(省局)向社会公开。其中,省局和市局的检查结果分别由各自录入医疗器械经营企业分类分级监督管理数据库。 四、医疗器械经营企业分类分级监管工作的开展要与《医疗器械经营质量管理规范》实施和医疗器械经营企业信用体系建设统筹结合,共同推进,进一步强化医疗器械经营企业质量第一责任人意识,不断增强监管的针对性和有效性,保障医疗器械经营和医疗器械产品的质量。 五、本通知自2016年2月1日起施行。 浙江省食品药品监督管理局
2015年12月30日
基本
文件
流程
错误
SQL
调试
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- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8] Undefined index: API_USER /www/wwwroot/drtyf.com/app/Lib/Model/home/apiBaseModel.class.php 第 9 行.
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- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
- [8192] preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead /www/wwwroot/drtyf.com/_core/Lib/Core/Db.class.php 第 571 行.
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- [8] Use of undefined constant id - assumed 'id' /www/wwwroot/drtyf.com/data/runtime/Cache/home/b4100acde3ddacd69acda060cdecd58b.php 第 1 行.
- [8] Use of undefined constant id - assumed 'id' /www/wwwroot/drtyf.com/data/runtime/Cache/home/b4100acde3ddacd69acda060cdecd58b.php 第 1 行.
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