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. Registrations are overseen by the Ministry of Food and Drug Safety (MFDS) under the Medical Device Act.
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.