Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration (TFDA) was established in 2010 to oversee food, drug, and medical device safety and quality. The TFDA deals with risk assessment, inspections, and market approvals for foods, drugs, biotech products, cosmetics, and medical devices.
The Division of Medical Devices & Cosmetics is in charge of the safety and quality control of medical devices, medical device regulation, and clinical diagnostics, as well as IVDs.
A list of TFDA regulations can be found here on our website.
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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