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.
The South Korean MFDS medical and IVD device approval process explained
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.
Determine the classification of your device according to the MFDS classification listing.
Appoint a local South Korea License Holder (KLH) to manage your device registration and interact with the MFDS on your behalf.
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).
Depending on the device classification, prepare a notification or registration application with supporting documents for submission to the relevant review body.
Pay any applicable fees. For medium- and high-risk devices, the relevant body reviews the application and may request additional information.
Upon approval, the review body will issue the marketing authorization and publish the device registration on the MFDS website.
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for South Korea when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.