Ready to sell your medical device in the United States? The first step is to classify your device according to the US FDA classification system. And as many medical device manufacturers know – this is not an easy task.
The US FDA uses a complex predicate system, and misclassifying your device can be a costly and time-consuming mistake. Knowing the correct classification of a medical device is critical for identifying its proper regulatory route in the United States. Emergo has successfully classified thousands of devices in the US, and we discuss the US classification process in this 13-page white paper. You will learn:
We answer all of these questions and many more in this white paper.
Stuart Goldman is a Senior RA/QA Consultant at Emergo.
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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