When you make design changes to an existing medical device, requirements in most major markets indicate you must notify the regulatory authority of your change. Unlike other markets, Japan PMDA registrants must submit even minor device changes. Sometimes, manufacturers, especially foreign manufacturers, overlook requirements to submit Minor Change Notifications and/or Partial Modification Applications.
This whitepaper will identify key points for specific regulatory procedures to follow when notifying Japanese regulators of design changes to your device, as well as risks if you do not follow these submission procedures. You will learn:
You will learn all this and more in this 15-page white paper.
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:
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