The cost and time for medical device registration and approval in South Korea will vary depending on device classification and the existence of a predicate device registered in Korea. Registrations are overseen by the Ministry of Food and Drug Safety (MFDS) formerly the Korea Food and Drug Administration (KFDA) under the Medical Device Act.
Low Risk Class I medical devices are subject to Pre-Market Notification (PMN). Applications are submitted to the MDITAC (Medical Device Information & Technology Assistance Center) through the MFDS e-submission systems and are considered accepted upon submission. A PMN number is issued on notification. There is a US$35 MFDS fee to process the application.
There are two regulatory pathways for Class II medical devices. With a registered predicate (Substantial Equivalent), product registration applications qualify for third party review of the medical 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 official time to process an application by a third party reviewer is 25 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 an 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.
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