Posted April 2015.
With 50 million residents and high per capita spending on healthcare, South Korea is one of the largest Asian healthcare markets, roughly equal in size to India. All medical devices in South Korea must undergo an approval process overseen by the Ministry of Food and Drug Safety (MFDS).
This six-part video describes the steps for manufacturers to import their devices into South Korea, breaking it down into easy to follow steps. Once you begin the series you may skip to the next section at any time using the Playlist in the player window.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
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