All documents listed below were published by the Russian agency Roszdravnadzor and are in PDF format. The original document was in Russian, and was translated into English using a free translation tool. We have not verified the accuracy of the translation so use it for general informational purposes only.
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:
阅读更多自新欧盟医疗器械法规MDR (Medical Device Regulation 2017/745) 申请日期起,欧盟医疗器械监管当局就发布了一系列新文件及相关支持服务,旨在帮助医疗器械制造商适应新法规变更后的法规环境。 对此,作为在全球范围内经验丰富的医疗器械及IVD器械市场合
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