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.
No salesperson will call you
With 50 million residents and high per capita spending on healthcare, South Korea is one of the largest Asian healthcare markets, roughly equal in
read moreThe South Korean MFDS reviews and updates these documents frequently throughout the year. For the most current copies of the regulations please ref
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