《医疗器械经营质量管理规范》解读之二20231211
发布时间:2023-12-11
一、自动售械机的设置和管理
在医疗器械销售环节设置自动售械机,使医疗器械的可获得性更好、更快,在提高医疗器械可获得性的同时,相关质量管理需要加强。《规范》明确自动售械机是医疗器械零售经营场所的延伸,并对自动售械机的经营主体、设置位置、设置数量以及自动售械机功能、内部陈列环境、售后机制建立、贮存与出货、定期检查、销售凭据开具等提出具体要求,确保自动售械机的经营过程在质量受控的状态下运行,保证医疗器械产品和经营过程的质量安全。
二、多仓协同的设置和管理
随着我国物流业快速发展,结合已经发布实施的《国家药品监督管理局关于医疗器械经营企业跨行政区域设置库房办理事项的通告》《医疗器械经营质量管理规范附录:专门提供医疗器械运输贮存服务的企业质量管理》,《规范》新增了多仓协同的条款,明确规定企业可通过跨行政区域设置仓库、委托跨行政区域的专门提供医疗器械运输、贮存服务的企业等方式,构建全国或者区域多仓协同物流管理模式。企业应当对跨行政区域设置的仓库加强质量管理,配备与经营企业本部互联互通、能够实时交互医疗器械贮存、出入库数据的计算机信息系统等。
三、直调运营的条件和管理
《规范》明确了企业在保证医疗器械购销渠道安全和产品质量可追溯的前提下,对于发生灾情、疫情、突发事件、临床紧急救治等特殊情况,或者经营医用磁共振、医用CT等大型医用设备以及其他符合国家有关规定的情形,可采用直调方式购销医疗器械。企业应当加强直调方式购销医疗器械的质量管理,应当在购销前对供货者、购货者以及医疗器械产品的资质合法性进行审核,并建立专门的直调医疗器械采购记录,保证有效的质量跟踪和追溯。
四、在库贮存医疗器械有何新的要求?
企业应当根据医疗器械的质量特性进行合理贮存。根据医疗器械产品的实际情况,《规范》对在库贮存管理进行了修订和细化,如:在冷库贮存时,应当根据冷库验证报告确定合理的贮存区域,制冷机组出风口应当避免遮挡。搬运、堆垛、放置医疗器械时,应当按照包装标示要求规范操作,堆垛高度、放置方向等应当符合包装图示要求,且应当按照货架、托盘承重范围等要求妥善存放,避免损坏医疗器械。组合销售的医疗器械和非医疗器械可以不分开贮存;在实施自动化操作的自动化仓库中,医疗器械与非医疗器械可以按货位分开存放。库房贮存产品包含非医疗器械产品时,应当做好库房分区管理,应当充分评估非医疗器械产品对贮存环境与人员的污染风险,制定措施确保医疗器械贮存环境安全。
五、随货同行单应包含哪些内容?
《规范》规定从事医疗器械批发业务的企业,在医疗器械出库时应当附随货同行单,并加盖本企业或者委托的专门提供医疗器械运输、贮存服务企业的出库印章。随货同行单内容应当包括:供货企业名称,医疗器械注册人、备案人和受托生产企业名称,医疗器械的名称、型号、规格、注册证编号或者备案编号,医疗器械的生产批号或者序列号、使用期限或者失效日期、数量,医疗器械运输及贮存条件,专门提供医疗器械运输、贮存服务的企业名称(若有),收货单位名称、收货地址、联系方式、发货日期等。医疗器械直调购销的,供货者应当开具两份随货同行单,分别发往直调企业和购货者。直调随货同行单应当有明显的直调标识,并标明直调企业名称、直调原因。
六、运输环节应做好哪些记录?
《规范》明确了医疗器械运输环节应记录的内容。企业应当按照相关制度以及运输操作规程要求进行医疗器械运输,选择合理的运输工具及运输路线,做好运输过程的产品防护,确保运输过程医疗器械产品的质量安全,并做好运输记录。运输记录应当包括:收货单位名称、地址、联系方式、运输方式,医疗器械名称、型号、规格、医疗器械注册证编号或者备案编号,生产批号或者序列号、单位、数量、发货日期等内容。委托运输时还应当记录承运单位名称和运单号,自行运输时应当记录运输车辆车牌号和运输人员。
七、售后服务有哪些要求?
《规范》规定企业应当按照与供货者在采购合同或者协议中约定的质量责任和售后服务责任,以及与购货者约定的质量责任和售后服务责任,提供相应的售后服务。企业可以自行提供售后技术服务,也可以由供货者或者第三方机构提供售后技术服务。企业使用第三方机构提供售后服务支持的,应当选择具备质量保障能力的服务机构,签订质量保证书面协议,约定双方质量责任和义务,明确售后服务的服务范围与质量管理要求。企业应当定期对服务机构的质量保障能力进行考核评估,确保售后服务过程的质量安全与可追溯。
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