Korea License Holder Change and Import Licence Transfer

1. Key takeaways

The Korean import item licence can be transferred. A licence holder change must follow the statutory procedure, and after completion the manufacturer and importer information in the UDI data must be updated in step. These are two tasks that must run in linkage; omitting either creates a gap where the licence entity and the UDI data entity no longer match.

• A change or transfer involves handling at 3 levels: the entity change at the licence level; the manufacturer and importer information update at the UDI data level; and the arrangement of stock on hand and goods in transit at the commercial level. The first two are compliance actions and the third is a commercial arrangement, but all three must advance on the same timeline.
• The transferee must satisfy the 4 eligibility conditions of a licence holder: a registered business premises in Korea, a dedicated quality manager, a valid import business licence and MFDS registration. This is a precondition for the transfer to stand, not a matter to be remedied afterwards.
• Import continuity during the transition must be designed separately, including how stock is consumed and in whose name importation proceeds.

2. Legal basis

The transfer procedure and the UDI update obligation rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

3. Expert insights

Insight 1: The UDI data update is the step most easily missed. The licence change and the UDI data update usually sit with two different teams: the former is handled by regulatory affairs staff, the latter by data maintenance staff. If the manufacturer and importer information in IMDIS is not revised in step after the change is completed, the two sides will show different entities at import. GRZAN sets this synchronisation as a mandatory node in the change process, not as a reminder. The practice is to list the UDI revision as a separate line in the change task list, with completion defined as the entity information retrieved from the IMDIS system having been updated and screenshotted for the record, rather than as the data maintenance staff merely having been notified.

Insight 2: The transferee’s qualification should be verified before the transfer, to avoid a completed change with inadequate qualification. The transferee must satisfy the 4 conditions of business premises, dedicated quality manager, import business licence and MFDS registration. If the transfer is completed first and the qualification remedied later, a window of holding the licence while non-compliant opens, during which every import carries a compliance defect. GRZAN places the transferee verification before the transfer application, using the same set of standards as the licence holder verification checklist in Article 31 of this series.

Insight 3: Import continuity during the transition needs separate design. During the change period, the former licence holder no longer holds the licence while the new licence holder has not yet completed the change; whether importation can continue, and in whose name, must be clarified in advance. Where Identical Product Registration (IPR) is used to split the licence-holding and import roles, the transition arrangement becomes more flexible, but IPR does not apply to Class 1 notification. GRZAN recommends writing the transition-period import plan into the agreement at the contracting stage, including how inventory is consumed.

Insight 4: A change resets the management baseline of several timelines. After the change is completed, the responsible entity for the item renewal (every 5 years), the KGMP certificate (valid for 3 years, with the periodic audit application due 90 days before expiry), the UDI data maintenance and other timelines shifts accordingly. If the ledger still sits under the former entity, expiry reminders stop working. The ledger handover must therefore be completed together with the change.

4. Practical recommendations

• Verify the transferee’s 4 eligibility conditions before the transfer. Business premises, dedicated quality manager, valid import business licence and MFDS registration are all indispensable.
• Set the UDI data update as a mandatory node in the change process. Revise the IMDIS manufacturer and importer information immediately after the licence change is completed, and keep the modification record.
• State the transition-period import arrangements in the agreement, including inventory consumption, handling of goods in transit and the linkage of the importing entity’s name.
• Hand over the compliance ledger in step with the completed change. The item renewal, KGMP periodic audit and UDI maintenance timelines pass to the new entity.
• Keep a complete transfer document archive. Transfer applications, approval documents and UDI modification records are filed together for later renewals and inspections.

5. Verification checklist

• □ Transferee business premises: verify the Korean registered business premises record; the registered address matches the actual operating address.
• □ Transferee quality manager: verify the appointment documents and presence status; the manager is dedicated.
• □ Transferee import business licence: verify licence validity; within the validity period, not suspended or revoked.
• □ Transferee MFDS registration: verify the registration record in the MFDS system; formal registration is complete.
• □ Licence change procedure: check the transfer application and approval documents; the statutory procedure is complete and the documents are on file.
• □ UDI data synchronisation: check the IMDIS manufacturer and importer information; consistent with the licence holder after the change.
• □ Ledger handover: check the renewal, KGMP and UDI maintenance timelines; the responsible entity is updated and reminders remain effective.
• □ Regulatory information verified as of 29 October 2026 (pending verification for any later amendments).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team coordinates licence holder arrangements, import business registration, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com