出口准入必看|医疗器械CE认证注册流程指南
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">供给</span><span style="color: black;">制品</span>CE认证、UKCA认证、FDA注册、欧盟授权<span style="color: black;">表率</span>、英国授权<span style="color: black;">表率</span>、瑞士授权<span style="color: black;">表率</span>、<span style="color: black;">制品</span>全生命周期检测咨询、为企业筛选供应商资质证书等服务；<span style="color: black;">同期</span>为检测认证行业的创业者（企业及个人）<span style="color: black;">供给</span>业务培训、<span style="color: black;">途径</span><span style="color: black;">创立</span>、团队搭建、经验分享等服务。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">按照</span>MedTec Europe统计，2022年欧洲医疗器械市场规模约为1350亿欧元，约占<span style="color: black;">全世界</span>市场的27％，是仅次于美国的第二大医疗器械市场。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">自2021年5月起，医疗器械制造商<span style="color: black;">必要</span>遵守欧盟医疗器械法规2017/745而不是医疗器械指令93/42/EEC</span><span style="color: black;">，<span style="color: black;">才可</span><span style="color: black;">得到</span>CE标志<span style="color: black;">准许</span>。<span style="color: black;">因此呢</span>，医疗器械<span style="color: black;">必要</span><span style="color: black;">按照</span>MDR进行<span style="color: black;">归类</span>。<span style="color: black;">为了证明您的设备符合这些CE指令的基本<span style="color: black;">需求</span>，您<span style="color: black;">必须</span>在其上贴上CE标志。您的<span style="color: black;">制品</span><span style="color: black;">必须</span><span style="color: black;">经过</span>CE认证标记过程。后者的方向取决于您的医疗器械类别和您<span style="color: black;">选取</span>的合格评定途径。您的医疗设备的<span style="color: black;">详细</span>特性将决定其类别，以及对<span style="color: black;">病人</span>的<span style="color: black;">危害</span>程度。例如，预期用途、侵入性以及局部与全身效应等特征。</span></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">CE认证是欧盟的一种强制性认证，<span style="color: black;">表率</span>着<span style="color: black;">制品</span>符合欧洲的安全、卫生、环保等方面的标准和<span style="color: black;">需求</span>。若企业想要在欧洲市场<span style="color: black;">营销</span>医疗器械，则<span style="color: black;">必须</span><span style="color: black;">保证</span><span style="color: black;">制品</span>符合CE认证标准和<span style="color: black;">需求</span>。要<span style="color: black;">得到</span>CE认证，企业<span style="color: black;">必须</span>找到一家专业的认证<span style="color: black;">公司</span>进行认证申请，并按<span style="color: black;">需求</span><span style="color: black;">供给</span><span style="color: black;">关联</span>的<span style="color: black;">制品</span>测试、<span style="color: black;">评定</span>和审核报告材料。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://p26-sign.toutiaoimg.com/tos-cn-i-qvj2lq49k0/dd1b300e992149088dcf65911277868e~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723310446&x-signature=N9GfxeMrlcS0jQOVRgFGp1q%2Fez8%3D" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">医疗器械CE认证的流程</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">1. 确定适用标准：企业应<span style="color: black;">按照</span>医疗器械的类别和用途，确定适用的欧盟标准。<span style="color: black;">按照</span><span style="color: black;">区别</span>类别和用途的医疗器械，标准和<span style="color: black;">需求</span><span style="color: black;">亦</span>会有所<span style="color: black;">区别</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2. 编制技术文件：企业应编制符合CE认证<span style="color: black;">需求</span>的技术文件，<span style="color: black;">包含</span><span style="color: black;">制品</span>说明书、技术规范、测试报告、<span style="color: black;">危害</span><span style="color: black;">评定</span>等。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">3. <span style="color: black;">选取</span>认证<span style="color: black;">公司</span>：企业<span style="color: black;">能够</span><span style="color: black;">选取</span>欧洲认证<span style="color: black;">公司</span><span style="color: black;">或</span>国内代理<span style="color: black;">公司</span>进行CE认证申请。<span style="color: black;">选取</span><span style="color: black;">公司</span>时应<span style="color: black;">思虑</span><span style="color: black;">公司</span>的资质、经验和服务能力等<span style="color: black;">原因</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">4. 测试<span style="color: black;">评定</span>：认证<span style="color: black;">公司</span>会对医疗器械进行测试和<span style="color: black;">评定</span>，<span style="color: black;">包含</span><span style="color: black;">制品</span>设计、生产工艺、性能、安全、卫生等方面。测试和<span style="color: black;">评定</span>的标准和<span style="color: black;">办法</span><span style="color: black;">按照</span><span style="color: black;">区别</span>的标准和医疗器械类别而有所<span style="color: black;">区别</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">5. <span style="color: black;">花费</span>支付：企业<span style="color: black;">必须</span>支付申请费、测试<span style="color: black;">评定</span>费及<span style="color: black;">关联</span>材料制作费等<span style="color: black;">花费</span>，由认证<span style="color: black;">公司</span><span style="color: black;">按照</span><span style="color: black;">详细</span><span style="color: black;">状况</span>报价。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">6. 收到证书：<span style="color: black;">经过</span>审核后，认证<span style="color: black;">公司</span>会<span style="color: black;">颁布</span>相应的证书和标识，标识<span style="color: black;">包含</span>CE标志和证书号码等，证书<span style="color: black;">通常</span>有效期为5年。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">7. <span style="color: black;">守护</span>证书：企业应<span style="color: black;">定时</span>对医疗器械进行质量管理和监督，并与认证<span style="color: black;">公司</span>保持联系，<span style="color: black;">即时</span>更新证书。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">必须</span><span style="color: black;">重视</span>的是，医疗器械CE认证的流程和程序比较<span style="color: black;">繁杂</span>，且<span style="color: black;">必须</span>花费较<span style="color: black;">长期</span>和<span style="color: black;">海量</span>的人力和物力成本。<span style="color: black;">因此呢</span>，企业应提前做好准备，<span style="color: black;">保证</span><span style="color: black;">制品</span>符合<span style="color: black;">关联</span>标准和<span style="color: black;">需求</span>，<span style="color: black;">才可</span>顺利<span style="color: black;">经过</span>CE认证。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://p3-sign.toutiaoimg.com/tos-cn-i-qvj2lq49k0/27099f0f55ab482a8491cc8d8f276576~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723310446&x-signature=GVUXZ8%2FfDhrIdZyD%2Fj6zY8p0aYU%3D" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">医疗器械CE认证所需的技术文件</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">医疗器械CE认证所需的技术文件<span style="color: black;">包含</span>：</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">1.<span style="color: black;">制品</span>说明书：<span style="color: black;">包含</span>医疗器械名<span style="color: black;">叫作</span>、型号、规格、适用范围、功能特点、<span style="color: black;">运用</span><span style="color: black;">办法</span>、<span style="color: black;">守护</span>保养等信息。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2.技术规范：<span style="color: black;">包含</span>器械设计图纸、技术<span style="color: black;">需求</span>、工艺流程、生产工艺、质量标准等信息。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">3.<span style="color: black;">危害</span><span style="color: black;">评定</span>报告：对医疗器械的可能<span style="color: black;">危害</span>进行<span style="color: black;">评定</span>，<span style="color: black;">包含</span><span style="color: black;">运用</span>过程中的<span style="color: black;">危害</span>、可能的危险<span style="color: black;">状况</span>以及<span style="color: black;">危害</span>的减轻<span style="color: black;">办法</span>等信息。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">4.测试报告：<span style="color: black;">包含</span>对医疗器械进行的各项测试、<span style="color: black;">实验</span>结果、测试<span style="color: black;">办法</span>、测试环境等信息。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">5.生产工艺<span style="color: black;">掌控</span>文件：<span style="color: black;">包含</span>生产工艺流程、工艺参数、器械检验标准、检验程序等信息，以<span style="color: black;">保证</span>医疗器械的质量和安全性。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">6.原材料及供应商信息：<span style="color: black;">包含</span>医疗器械所<span style="color: black;">运用</span>的原材料名<span style="color: black;">叫作</span>、标准、供应商信息以及原材料检验<span style="color: black;">需求</span>等信息。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">7.质量体系文件：<span style="color: black;">包含</span>医疗器械质量体系手册、程序文件、工作<span style="color: black;">指点</span>书、检验标准、<span style="color: black;">守护</span>记录等信息，以<span style="color: black;">保证</span>医疗器械生产过程的质量和稳定性。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">8.临床<span style="color: black;">评估</span>文件：对医疗器械的安全性、有效性、适用性等进行临床<span style="color: black;">评估</span>的文件，<span style="color: black;">包含</span>临床<span style="color: black;">实验</span><span style="color: black;">方法</span>、<span style="color: black;">实验</span>报告、文献综述等。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">9.标签、说明书、包装文件：<span style="color: black;">包含</span>医疗器械标签、<span style="color: black;">运用</span>说明书、包装说明书等。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">必须</span><span style="color: black;">重视</span>的是，以上技术文件是医疗器械CE认证所必需的文件，企业应<span style="color: black;">根据</span><span style="color: black;">需求</span>认真编制和整理。<span style="color: black;">同期</span>，<span style="color: black;">按照</span>医疗器械的<span style="color: black;">详细</span><span style="color: black;">状况</span>和标准<span style="color: black;">需求</span>，在技术文件中还可能<span style="color: black;">必须</span><span style="color: black;">包括</span>其他的信息和证明材料。</span></p>
你的话语如春风拂面，让我感到无比温暖。 外链发布社区 http://www.fok120.com/
页:
[1]