If you are thinking about entering the South Korean market for the first time, understanding Korea's Ministry of Food and Drug Safety (MFDS) regulatory requirements can be overwhelming. Information about medical device regulations on the MFDS website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer.
To help medical device manufacturers who want to export medical devices to South Korea, we assembled a packet that includes the basic information you need before deciding to enter the South Korean market. It outlines the registration requirements and ongoing obligations to maintain compliance.
If you set aside just one hour to read/watch these items, we guarantee you will have a MUCH better understanding of how the MFDS's regulatory process works.
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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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