All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Europe, you may be interested in our custom regulatory strategy reports for Europe. This is not a complete list. See the EC website regulatory section pertaining to medical devices.
我们的专家将详细解读2023年韩国食品药品安全部(MFDS)指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范(KGMP)等相关要求,并将依据多年韩国本地注册经验提供注册案例分享。此外,您还将了解到制造商在面对MFDS监管时需要关注的核心要点,相关研讨会内容包括:
阅读更多在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械,并且符合MDR 2017/745下的一般安全和性能要求(GSPR)。法定制造商将验证是否符合所有相关的欧盟要求,并必须在其欧盟符合性声明(DoC)中声明这一点。此外,高风险器械(MDR下
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