Medical Device Samples for Testing or Exhibitions in Korea

Key point — The actual purpose, rather than the invoice label or price, determines the route. Connect entry requirements, location, duration, permitted activities and disposition in one plan.

Define the purpose before calling it a sample

A free device may be intended for registration testing, development research or physical inspection. Clinical investigations, quality testing and exhibition demonstrations should not be grouped into one undifferentiated sample category. A plan to use the device on patients requires a separate assessment.

Article 3 of the current notice on exemptions from medical device import requirement verification identifies eligible categories. Article 4 requires a recommendation before importation. Free supply, low quantity or an intention not to sell does not by itself establish eligibility. Keep the sample route separate from the commercial Korean registration pathway.

Match evidence and quantity to the purpose

Do not extend the two-unit criterion in Article 6 to every type of testing product. Conversely, describing a shipment as physical inspection samples does not justify a larger testing quantity. Explain how products and models are distinguished and reconcile names and quantities across the invoice, packing list and plan.

Distinguish recommendation from testing confirmation

Article 5 assigns the recommendation body by category: the Korea Medical Devices Industry Association for Article 3 categories 1–8, and the National Institute of Medical Device Safety Information for categories 9–11. Some routes also require confirmation under Article 8. Planning only for the final waiver recommendation can therefore leave an earlier step unfinished.

Relevant information includes the device's form, performance, purpose, quantity, use period and post-use disposition. Certain testing categories use designated testing-body confirmation routes. Do not assume every application goes to the same office. Before fixing a shipping date, list the required steps, receiving body, documents and owner for each product.

Assess exhibition approval and booth activities separately

Advance approval is required for display under Article 46 of the Medical Devices Act Enforcement Rule. Articles 56–58 of the authorization and review regulation cover exhibition plans, product and promotional information, identification as an exhibition device, and approval scope. Import waiver status does not replace exhibition approval.

Confirm which simple operations and explanatory or promotional materials are permitted. Prepare the required marking identifying an exhibition or unauthorized device. Providing diagnostic results or treatment to visitors must not be reclassified as a simple demonstration merely for convenience. Brief the sales team and booth contractor on the permitted activities for each product.

Reassess before changing the purpose

A physical inspection sample may later be wanted for registration testing, or an unused test device for an exhibition. Article 9 of the exemption notice specifies permitted change-of-use routes. In specified testing or sample-to-exhibition cases, exhibition approval can be treated as change-of-use approval. This provision does not authorize every possible conversion.

Recheck the original entry basis, product identity, use period and disposition plan before switching purposes. Do not move a device into commercial loan stock or saleable inventory while leaving its original plan unchanged. As the intended-use boundary guide explains, actual use and claims matter.

Reconcile quantities through closure

As a practical control, link the model and serial number, entry date, approval or confirmation documents, storage location, responsible user, test or exhibition record, remaining quantity and final disposition evidence. Destroyed test units, units returned to the manufacturer and remaining exhibition units should reconcile with the imported quantity.

This is not a universal retention period for all samples. It is a method for demonstrating use consistent with the applicable conditions. Send the product description, purpose, quantity and intended schedule for a free preliminary review with Clare Partners.

Official sources checked on 2026-09-28: Import Requirement Verification Exemption Notice 2026-27; Enforcement Rule, Article 46; Authorization and Review Regulation, Articles 56–58-2. Recheck current rules and individual approval conditions before shipment.