A Manufacturer Discontinues a Device: Korea Supply and Service Planning

Key point — Discontinuation comprises several ending activities, not one date. Start reporting-scope assessment and support planning for installed devices together.

Break the notice into dates and scope

A notice may identify only a last-order date while parts and software support follow separate policies. Ask the manufacturer for production cessation, final shipment, Korean supply, repair parts and security support dates. Map manufacturer model names to Korean authorized models.

Establish whether the change covers an entire device, specific models, packaging sizes or individual components. A successor in the same family may not work with installed equipment or consumables. Quality, regulatory and service teams should assess the impact alongside the sales team's final-order plan.

Determine whether mandatory reporting applies

The current notice on devices subject to production or import discontinuation reporting relies on a scope announced by MFDS in consultation with the relevant ministry. Do not decide eligibility solely because a device appears important for life support, emergency care or surgery. Compare the actual announcement with the product information. Commercial discontinuation of every device is not subject to the same reporting duty.

For a covered product, the general rule is reporting 180 days before discontinuation. Where specified unavoidable circumstances prevent this, review the provision for reporting within ten days after discontinuation with reasons. A late manufacturer notice does not automatically establish an exception. Assess the cause, awareness date and effect on Korean supply.

Test exceptions against actual supply continuity

Article 3 provides exceptions for specified circumstances, including supply of the same product by another Korean company, where there is no actual supply disruption. Finding a potential new importer or a similar alternative does not by itself establish the exception. Verify the same-product supply arrangements, inventory and expected deliveries.

Voluntary reporting for products outside the mandatory scope is a separate provision. Retain the scope check, applicable provision, affected products, dates and exception rationale. Where an importer change is involved, connect this work with the importer handover plan.

Plan support for installed devices

Average sales alone may create excess final-buy inventory that expires before use. Consider actual installed demand, support duration, storage conditions and expiry. A needed replacement part cannot simply be substituted outside the approved design: assess effects on safety, performance and regulatory status.

Explain the impact accurately to customers

Identify affected models, implications for current use, continuing support, ordering and service contacts. A bare discontinuation announcement may be mistaken for an immediate stop-use instruction or recall. Conversely, emphasizing a replacement may obscure compatibility or authorization limits. Commercial discontinuation, safety action and recall require separate decisions.

Offer the successor only after checking Korean authorization, intended use, accessory and consumable compatibility, installation and training. Continue assessing safety information concerning the old device regardless of its commercial status. Retain ongoing duties in the post-approval obligations guide within the support plan.

Record what remains open

Link accountable owners, manufacturer responses, inventory assumptions, customer notice versions and reporting decisions. Do not treat an estimated final shipment as confirmed stock. When manufacturer plans change, update the Korean customer communication and reporting assessment together.

Clare Partners can organize scope verification, replacement or change assessment and postmarket work using the manufacturer notice and Korean product records. Send the notice and affected model list through a free preliminary review.

Official sources checked on 2026-09-28: Production and Import Discontinuation Reporting Notice 2025-84, Articles 2 and 3; KGMP Notice 2026-46, Annex 2 sections 7.3.9, 7.4 and 7.5.4. Reconfirm the announced reporting scope and actual supply circumstances when acting.