GuidelinesImport & customs2026.10.23
Changing a Korean Medical Device Importer: The Handover File
Changing a distribution agreement does not by itself transfer a Korean product authorization. Connect regulatory status, inventory, technical records and postmarket responsibilities before switching import partners.
Key point — A signed replacement contract is only one milestone. Confirm who holds each regulatory status, which stock each party can handle, and how safety information from existing customers will continue to flow.
Separate the contract from regulatory status
A foreign manufacturer may set clear dates for ending one exclusive distribution agreement and starting another. Distribution rights, the Korean import business and individual product licenses, certifications or notifications are nevertheless distinct. Assuming the incoming partner can use documents issued in the outgoing partner's name may interrupt importation and supply.
Article 47 of the Medical Devices Act addresses succession through business transfers and transfers of the business relating to a product. Review whether the transaction meets those conditions and what procedure and evidence are needed. Replacing a sales agent may differ from transferring an import product. Start by mapping the Korean authorization holder.
Build a product-level handover index
A company-wide document transfer can miss individual models and amendment histories. Index records by product authorization number and model, including the current version, earlier revisions and pending applications. This working index does not replace an official application form.
| Area | Information to verify | Evidence of completion |
|---|---|---|
| Regulatory status | Number, models, holder, expiry and pending changes or renewals | Current records and completed decisions |
| Technical and quality | Review files, test reports, manufacturing sites, GMP scope and rights to use data | File index and manufacturer confirmation |
| Product movement | Import, shipment and return history, lot or serial numbers and storage locations | Reconciled quantities and handover record |
| Postmarket work | Open complaints, adverse events, advisory notices, recalls and corrective actions | Named owner and next action for each case |
Possessing a PDF does not necessarily establish the right to use its contents. If confidential manufacturer information was submitted directly to a reviewing body, agree how the new team can obtain authorized access or arrange resubmission when necessary.
Identify the status of transition inventory
Separate releasable stock, held stock, returned or investigated units, and expired units. Reconcile quantities by model and lot. Distinguish the owner, physical custodian and party responsible for sale. Check which registered information underlies the labeling and Korean instructions.
For example, 80 units in the outgoing importer's warehouse and 20 already supplied to a distributor cannot be treated as one undifferentiated transfer. The supplied units require continuing customer contact and recall traceability; warehouse units still need condition and distribution-route checks. Applying the new company's label is not a substitute for assessing change procedures and labeling requirements.
Keep existing customers within the safety system
A complaint received after contract termination may concern a product sold earlier. If the outgoing importer, incoming importer and manufacturer each assume another party is responsible, evaluation and reporting can be delayed. Maintain contact routes for previously sold products in light of the adverse-event and recall duties in Article 31.
Transfer the intake channels, manufacturer safety contacts, awareness dates and reporting status of open cases, and outstanding follow-up information. Handle customer information within the necessary scope and through a lawful transfer process. Link decisions to the adverse-event reporting requirements. Assigning a coordinator does not eliminate any party's statutory responsibility.
Give unfinished work its own register
A current certificate is not enough if unanswered regulator requests, planned site changes, approaching renewals or manufacturer corrective actions are omitted. Check how pending and future submissions share evidence and whether a change in applicant affects them. The certificate lifecycle guide explains why reissuance and regulatory changes must be distinguished.
Transfer access through appropriate user permissions instead of sharing passwords wholesale. Identify signing authority, electronic submission users and manufacturer document contacts. Record any interim support period, backup contact and missing-file recovery plan.
Test the handover using one actual product
Trace a representative product from its current authorization to an imported lot, delivery destination, customer inquiry and manufacturer investigation. The incoming team should be able to retrieve the record and decide the next action. Compare the commercial launch date with completion of regulatory procedures, inventory decisions and postmarket arrangements separately.
Clare Partners can organize a product-level handover around your current authorization structure and proposed changes. Share the outgoing and incoming entities, product list and intended transition date through a free preliminary review.
Official sources checked on 2026-09-28: Medical Devices Act, Articles 31, 47 and 48, effective 2026-07-01; Medical Device Manufacturing and Quality Management Standards, Notice 2026-46. The index and handover exercise are practical recommendations, not a substitute for transaction-specific legal assessment.
Frequently asked questions
- Q. Can the new importer use the previous authorization when exclusivity ends?
- Ending an exclusive agreement does not automatically transfer a product license, certification or notification. Determine whether business or product succession procedures apply or a new regulatory route is needed.
- Q. Must all existing stock move to the new importer?
- Assess ownership, storage, condition and the lawful distribution route separately. Physical movement alone does not establish regulatory succession or eligibility for release.
- Q. Who handles complaints about products sold before the transition?
- Identify the applicable legal responsibilities, then name the people handling intake, evaluation, manufacturer contact, reporting and recall execution. A private agreement cannot simply remove statutory duties.