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
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 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.
For Class II devices, obtain Korea Good Manufacturing Practices (KGMP) certification through an onsite audit. Class II device manufacturing facilities are usually audited by a Third Party Auditor. For Class III and IV devices, obtain Korea Good Manufacturing Practices (KGMP) certification through an onsite audit. Class III and IV device manufacturing facilities are audited by a Third Party Auditor and the MFDS. For all applicable classes, the KGMP certification must be renewed every 3 years.
For Class II, III and IV devices, send your device to Korea for testing OR prepare existing equivalent Korea testing results. ***
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. For Class III and IV devices, prepare registration application in Korean, including technical file, test reports and KGMP certificate. Class IV devices require an additional technical file in STED format.
For Class I devices, KLH submits Pre-Market Notification application to the MFDS database. For Class II devices, KLH submits Korean registration dossier to a certified Third Party Reviewer. Application includes technical file, test reports, and KGMP Certificate. After successful Third Party Review, the MFDS will issue the final approval. For Class III and IV devices, KLH submits Korean registration dossier to the MFDS for review. Dossier includes the Technical File plus STED Technical File (Class IV), test reports, and KGMP certificate. All classes of devices must pay applicable application fees.
Class I devices do not require approval, only Notification to the MFDS. The MFDS will publish the device on their website. Class I notifications do not expire. For Classes II, III, and IV devices, a full application review conducted. Pre-Market Approval license is issued by the MFDS and published on their website. Registrations do not expire.
Manufacturers of all classes of devices must appoint a qualified importer/distributor to bring your device into South Korea. 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, formerly Safety and Efficacy Review (SER). 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, i.e. no Technical File, as well as an expedited review by a Third Party Reviewer.
*** 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: 07/04/2015