中国质量新闻网讯 为进一步规范医疗器械生产秩序，压实企业质量安全主体责任，保障医疗器械产品质量安全有效，守护群众用械安全，近日，河北省衡水市市场监督管理局高新区分局组织开展医疗器械生产企业规范提升专项检查行动。
本次专项检查严格对照监管标准和工作方案，对辖区医疗器械生产企业开展全方位、全覆盖检查。重点核查企业生产许可、备案资质、产品注册信息与实际生产情况是否一致，严查无证生产、超范围生产、使用未经注册备案产品等违法违规行为；细致核对产品技术要求，确保完全符合国家强制性标准，规范产品标签说明书使用管理。同时，全面检查企业关键岗位人员配置、生产环境条件、质量管理制度落地、生产检验记录追溯等质量保证能力，精准排查生产环节各类风险隐患。
下一步，衡水市市场监督管理局高新区分局将持续跟进问题整改落实情况，常态化开展整改“回头看”，严厉查处各类违法违规行为，同步加强企业质量安全培训和警示教育，倒逼企业规范生产、诚信经营，持续推动辖区医疗器械产业高质量发展。（来源：河北省衡水市市场监管局）
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