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South Korea Medical Device Classification

Before medical device manufacturers can legally sell their products in South Korea, they must comply with medical device regulations set forth by South Korea’s Ministry of Food and Drug Safety (MFDS).

In South Korea, it is extremely important to accurately classify your medical device prior to beginning the MFDS registration process. Improper classification can significantly impact the regulatory approval process and the costs you incur.

Determining Your Device Classification in South Korea

The first step in the South Korean registration process is to determine the classification of your device by referencing the rules found in MFDS Notification No. 2014-110: Regulations for Product Classification of Medical Device and Class by Product.

Medical devices in South Korea are classified as Class I, Class II, Class III or Class IV based on increasing risk. A database of device descriptions with corresponding class and category can be found on the MFDS website.

When classifying your device, it’s important to consider that some products classified as medical devices in the US or EU may fall under a “quasi-drug” or drug status in South Korea.

Why choose Emergo to assist with medical device classification?

We have helped hundreds of medical device manufacturers register their devices with South Korea’s Ministry of Food and Drug Safety (MFDS).

  • Our team in Seoul specializes in medical device regulatory consulting and can help you determine the proper classification for your medical device or IVD.
  • We can assist you in preparing medical device registration application documents that demonstrate compliance with Korea’s MFDS regulations.
  • Our in-depth knowledge of South Korean medical device regulations ensures that we provide the most efficient and cost-effective approval strategy for your device.
  • Our Korean License Holder service allow us to submit devices to the MFDS for approval on your behalf and, more importantly, gives you the freedom to add or change distributors as needed

Please contact us for more information on medical device classification and registration in South Korea.

Ask us for detailed information about South Korea device classification services.

Learn about the process, costs and timelines.

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