【仁成医疗】医疗器械从业人员今后或将参加统一资格考试

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                    <p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">近年来，医疗器械技术发展日新月异，大量高技术含量的新型医疗器械进入市场，极大地提高了医疗诊治水平。同时，这也对医疗器械行业的从业人员提出了更高的要求。</p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">值得关注的是，在新一轮机构改革中，国家食品药品监督管理总局把原有的医疗器械监管司扩充为医疗器械注册管理司和医疗器械监管司，人员数量增加了近1倍。在政府机构精简的大环境下，这充分说明了国家对医疗器械行业的重视程度。</p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">医疗器械行业涉及学科多、技术复杂。然而<span style="max-width: 100%; color: rgb(0, 0, 0); box-sizing: border-box !important; word-wrap: break-word !important;">，我国尚未建立全国统一的医疗器械行业从业人员的职业资格考试制度。<span class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;">目前在业内具有一定影响力的资格考试有卫生部门组织的临床医学工程技术考试和浙江省食品药品监管局组织的医疗器械行业初、中级专业技术资格考试</span>。</span></p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">但是，前者仅仅是社会评价性考试，考试范围局限于上海、江苏、西藏、陕西等10个省（区、市），且考试对象大多来自医疗机构；后者局限于浙江省内，覆盖面很小。它们的社会认可度有限，无法满足医疗器械行业发展的要求。</p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvcq7JGSRkIlTA3AqDqQ1UHkAZwaLHaYxjrSj9NAcrTOIl48yyHd5lzruPnibcMPOJM4kyEePWYhsDQ/0?wx_fmt=jpeg" data-ratio="0.6672661870503597" data-w=""  /><br  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">这些情况导致用人单位在选人、用人时缺乏判断标准，使从业人员的整体素质受到影响，并且从业人员在职业发展、职称晋升等方面受到阻碍，进而使原本就短缺的人员队伍更加不稳定。医疗器械法律法规中也缺乏对从业人员资质的认定依据，这不利于器械行业的规范化。笔者认为，<span style="max-width: 100%; box-sizing: border-box; color: rgb(0, 0, 0); word-wrap: break-word !important;">我国建立统一的医疗器械职业资格考试制度的时机已经成熟</span>。</p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">首先，浙江省的资格考试具有一定示范作用。该省将考试分为医用机械工程类、医用光机电工程类、医用放射影像工程类、医用生化工程类、医疗器械临床工程类五大类，保证了从业人员的专业性和考试的可行性。近年来，通过该资格考试的大量专业人才对该省医疗器械产业的发展发挥了重要作用。</p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">其次，我国医疗器械监管系统已良好运行多年，建立全国统一的医疗器械职业资格认证体系，能够进一步强化监管的权威性。并且，国家食品药品监督管理总局在回归国务院直属管理后，可以制定部门规章、确立医疗器械职业资格考试制度，法理上的障碍已经扫除。</p><p><br  /></p><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br class="tn-Powered-by-gulangu" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"  /></section><section class="tn-Powered-by-gulangu" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; widows: 1; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"></section><p><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); widows: 1; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">第三，随着新版《医疗器械监督管理条例》的修订，监管部门可以逐步建立医疗器械从业资格准入制度，在法律层面上限定医疗器械生产、经营、使用单位具有医疗器械从业资格人员的最低数量，从根本上确保医疗器械行业专业化、规范化。</p><p style="max-width: 100%; min-height: 1em; white-space: pre-wrap; color: rgb(62, 62, 62); line-height: 25.6000003814697px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; 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