Get smart about South Korea in 1 hour
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CONTACT USIf 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.
Free information packet makes it easier to understand the process in South Korea
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.
Here is what we will send you
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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Introduction to South Korea Medical Device Approval Process
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South Korea Medical Device Regulations
The 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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