Medical device registration in South Korea
Medical device products registration in South Korea is regulated by the Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), under the Medical Device Act.
Medical device classification closely follows the Global Harmonization Task Force (GHTF) Classification guidelines, with Class I, II, III and IV designations ranked from low to high risk categorization.
Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.
Medical device classification closely follows the Global Harmonization Task Force (GHTF) Classification guidelines, with Class I, II, III and IV designations ranked from low to high risk categorization.
Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.
How to register for your medical device in South Korea
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.
Step 2
Establish local office and 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. Prepare test results.
Step 4
For Class I devices, prepare Pre-Market Notification including basic device information. For other 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 5
For Class I devices, KLH submits Pre-Market Notification application to the NIDS. For Class II devices, KLH submits registration dossier to a certified Third Party Reviewer or the NIDS. 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 6
Class I devices do not require approval, only Notification to the NIDS. 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 NIDS (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.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
