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South Korea MFDS (KFDA) Medical Device Registration and Approval

ANSWERED ON THIS PAGE:

  • What are the medical device registration requirements in South Korea?
  • Do we need in-country representation as a foreign manufacturer?
  • What documentation should we submit with our device registration?

Medical devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration (KFDA). Manufacturers must follow the requirements of the Medical Devices Act and register with the MFDS before entering the Korean market. The regulatory process has three main components and Emergo’s team in Seoul can assist in all of these areas:

  • Device classification and regulatory approval. The regulatory route is determined by a combination of classification and whether a Substantially Equivalent (i.e., predicate) device exists, similar to the US FDA process. There are four classes of medical devices: Class I, II, III, and IV.
  • Korean Good Manufacturing Practices (KGMP) certification. Manufacturers of Class II, III, and IV devices must be audited to KGMP requirements prior to commercialization in Korea. Once audited and the KGMP certificate has been issued, companies can submit their device registration to the MFDS for review. 
  • HIRA reimbursement. Many manufacturers who intend to sell their devices in Korea must obtain reimbursement/non-reimbursement approval from Korea’s Health Insurance Review and Assessment (HIRA) Agency.

Preparation of Korean MFDS medical device registration documents

The scope of a Korean technical file is similar to a European technical file/design dossier or a US FDA 510(k) or PMA submission. However, differences exist and all documents must be submitted in Korean. Most Class II, III, and IV products require additional testing to Korean product standards prior to submission of the registration application.

Before beginning a device registration with the South Korean MFDS, you will also be required to appoint a Korea License Holder. Foreign manufacturers without an office in South Korea are not allowed to submit medical device registrations to the MFDS; the Korea License Holder performs this task and controls your registration. Emergo can assist you with South Korea License Holder representation.

Emergo can help you start selling your medical device in South Korea

With a team of regulatory consultants in Seoul, Emergo is fully equipped to assist with regulatory approval in South Korea. We can:

  • Search for the appropriate product code, matching predicates sold in Korea, and determine proper classification
  • Evaluate your existing testing results and clinical data to ensure compliance with Korean  requirements
  • Evaluate your quality system procedures for compliance with KGMP requirements, and assist with modifications as needed
  • Compile your Korean Technical File and have all supporting documents translated into Korean
  • Serve as your Korean License Holder and liaise between you and the MFDS
  • Prepare and submit your MFDS registration application

South Korea is a dynamic market that is heavily reliant on medical device imports. It is a lucrative market and Emergo can help you access it. Contact us for more information on South Korea MFDS medical device registration and approval.

Common Korea device registration questions

Our product complies with international testing standards. Will our device require additional testing to enter the Korean market?
Most foreign products require supplementary testing prior to registration in Korea. The MFDS has local product standards and performance testing requirements that must be met, in addition to the internationally recognized test standards. Emergo can perform a gap analysis of your current test reports to assess compliance with MFDS testing criteria.

Do all medical devices require HIRA reimbursement approval?
Most manufacturers need to obtain reimbursement/non-reimbursement approval for their device from HIRA. HIRA approval is not required for home use devices sold directly to the end user or lower risk devices that are included in the procedure fee.

What is required for Class I devices?
Manufacturers of Class I devices (with predicates sold in Korea) do not require formal approval, only a notification to the MFDS. The application includes basic device information and an application fee. Class I manufacturers also do not need to comply with KGMP requirements. The MFDS will publish the device notification on their website less than a month after receipt.