中国质量新闻网讯 近日,山东省高密市市场监管局与潍坊市场监管局紧密协作,联合开展医疗器械经营企业专项检查行动,并对集采中选企业实施重点检查。
检查过程中,执法人员严格依据相关法律法规,围绕产品资质审核、采购验收管理、储存养护条件、质量管理制度等关键环节展开核查。执法人员仔细查验医疗器械注册证、经营许可证等证照是否齐全有效,采购合同、随货同行单、验收记录等是否完整规范。对于需要冷链管理的产品,着重检查温湿度监测记录以及设备运行状况是否符合要求。针对集采中选企业,更是加大了检查力度,详细核查了中选产品的采购、验收、销售等记录,确保产品来源可查、去向可追。
此次联合检查有效强化了对医疗器械经营企业的监管力度,进一步规范了企业的经营行为。下一步,高密市市场监管局将持续加大对医疗器械领域的监督检查力度,尤其是对集采中选产品的质量监管,为广大群众用上安全、有效的医疗器械提供坚实保障。同时,将通过加强对企业的宣传和指导,提高企业的质量安全意识和管理水平,共同营造安全、有序的医疗器械市场环境。(来源:高密市场监管)
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