IVD product registrations are overseen by the Ministry of Food and Drug Safety (MFDS) under the Medical Device Act. The cost and time to register an IVD device in South Korea will vary significantly depending on device classification and the existence of a predicate device registered in Korea. Classification in Korea closely matches GHTF guidelines. Predicacy is determined by a formal review process based on 5 to 6 categories.
Low-Risk Class I IVD devices are subject to Pre-Market Notification (PMN). Applications are submitted to the MFDS and are considered accepted upon submission. It takes one week to issue a PMN number. There is a US$35 MFDS fee to process the application.
There are two regulatory pathways for Class II IVD devices. With a registered predicate (Substantial Equivalent), product registration applications qualify for third party review of the IVD device and quality systems conformity assessments. There are 6 third party reviewers, 2 of which are international companies that also offer Notified Body/Registrar services. The average time to process an application by a third party reviewer is 35 working days, with an average cost of US$1,500. All other Class II devices are subject to a Safety and Efficacy Review by the MFDS with 80 day processing time for a fee of US$1,000.
Class III and Class IV devices are subject to Pre-Market Approval (PMA) with applications reviewed by the MFDS. The Substantial Equivalent review pathway takes 65 days and US$500, while the Safety and Efficacy Review pathway takes 80 days and US$1,000 to process.
Contact Asia Actual to see how we can help navigate the registration process for your IVD device in South Korea.