South Korea MFDS Medical Device Regulations

About MFDS medical device regulations in South Korea

All companies planning to sell a medical or in vitro diagnostic (IVD) device in South Korea must register their product with the Ministry of Food and Drug Safety (MFDS). There are three market authorization pathways, depending on the device classification. Additionally, all devices without a substantially equivalent predicate device in South Korea require clinical data review as part of the registration process.  

South Korean medical device regulatory process

The chart illustrates the MFDS approval process per device classification in South Korea and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here. 

Step 1
Determine the classification of your device according to the MFDS classification listing. 

Step 2 
Appoint a local South Korea License Holder (KLH) to manage your device registration and interact with the MFDS on your behalf. 

Step 3 
Unless your device is in the lowest risk classification, submit an application for Korean Good Manufacturing Practices (K-GMP) certification to an authorized Third Party Auditor and send your device to South Korea for any required testing (or to a laboratory outside of South Korea that can test to the MFDS requirements). 

Step 4 
Depending on the device classification, prepare a notification or registration application with supporting documents for submission to the relevant review body.  

Step 5 
Pay any applicable fees. For medium- and high-risk devices, the relevant body reviews the application and may request additional information. 

Step 6 
Upon approval, the review body will issue the marketing authorization and publish the device registration on the MFDS website.