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. Korea’s population is aging quickly and so is spending on medical devices. Interested in getting your share of the Korean market? This 4 minute video provides a high level overview of the South Korean registration process.
Download the medical device Regulatory Process Chart for South Korea.
Watch the in-depth video on The Regulatory Process in South Korea [Runtime: 15 minutes]
Download medical device regulations for South Korea.
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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