Medical device and IVD manufacturers that want to sell their products in South Korea will have to follow the requirements of the Medical Devices Act, a set of regulations put forth by the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration). For more information on getting approval for the South Korean Market, download the chart.
The South Korean medical device approval process explained
Step 1
Determine classification of your device based on the device database, regulations provided by South Korea’s Ministry of Food and Drug Safety (MFDS), as well as identified predicate devices in the South Korean market. If no predicate exists, the device will follow the Clinical Data Review route.* Devices are divided into four classes of increasing risk: Class 1, Class II,** Class III, and Class IV.
Step 2
If you do not have a local office in South Korea, you must appoint a Korea License Holder based in the country to manage your medical device registration with the MFDS.
Step 3
For Class II, III and IV devices, obtain Korea Good Manufacturing Practices (KGMP) certification. Class II manufacturers are usually audited on-site by a Third Party Auditor (TPA) whereas Class III and IV manufacturers are audited on-site by a TPA and the MFDS. KGMP certification must be renewed every 3 years..
Step 4
For Class II, III and IV devices, send your device to Korea for testing OR prepare existing equivalent Korea testing results. ***
Step 5
For Class I devices, prepare Pre-Market Notification including basic device information. For Class II devices, prepare registration application in Korean, including technical file, test reports and KGMP certificate. Technical file for Class IV devices must be in STED format.
Step 6
For Class I devices, KLH submits Pre-Market Notification application to the MDITAC. For Class II devices, KLH submits registration dossier to a certified Third Party Reviewer or the MDITAC. For Class III and IV devices, KLH submits registration dossier to the MFDS for Safety and Efficacy Review. All classes of devices must pay applicable application fees.
Step 7
Class I devices do not require approval, only Notification to the MDITAC. They will publish the device to the MFDS website. Class I notifications do not expire.
For Classes II, III, and IV devices, after successful review, the MDITAC (most Class II devices) or MFDS (novel Class II and all Class III and IV devices) will issue the final Pre-Market Approval license and publish on their website. Registrations do not expire as long as changes are not made to the device or its intended use.
Step 8
You are now authorized to begin marketing your device.
* If your device (all classes) is new or does not have a predicate in the South Korean market, then the MFDS will require a Clinical Data Review. Manufacturers will be required to submit clinical data with their application and the registration approval timeline and fees will increase accordingly.
** There are approximately 350 Class II devices that MFDS considers “Special Equivalent,” which require a less robust application, and no Technical File review. These devices can be reviewed by a Third Party Reviewer or the Medical Device Information & Technology Assistance Center (MDITAC). Novel Class II devices still require MFDS approval.
*** Prior testing done in accordance with ISO or other international standards will satisfy some testing requirements; however, most manufacturers have to conduct additional testing, including performance testing, to Korea specific product standards.
This is a simplified overview of the process. The MFDS may choose to audit your submission and request more documents, which will add time to your approval.
Chart updated: 10/3/2017
