Korean Medical Device Import Business Licence: Conditions and Scope

1. Key takeaways

Any business engaged in importing medical devices into Korea must first obtain an import business licence, whose statutory basis is Article 15 of the Medical Devices Act. The import business licence and the item licence are two distinct layers: the import business licence settles who may import, while the item licence settles which product may be imported. Neither can substitute for the other.

• The statutory conditions for the import business licence fall into 4 categories: business premises, storage facilities, quality inspection facilities and equipment, and a quality manager. The first 3 are facility conditions; the 4th is a personnel condition.
• Comparison with the manufacturing licence (Article 6) reveals the legislative intent: manufacturing requires manufacturing premises, a laboratory for raw material and product quality management, storage facilities, and the facilities and equipment needed to maintain manufacturing and quality, plus at least 2 manufacturing managers and 1 quality manager; the import business carries no manufacturing manager or laboratory requirement but retains the storage and quality inspection capability requirements.
• The import business licence is a business qualification for the entity, valid long term and covering multiple items, whereas the item licence is a product qualification, one licence per product. Companies should plan these as 2 parallel tracks, not as a serial wait.

2. Legal basis

The requirements described above rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

3. Expert insights

Insight 1: The import business licence is a business qualification, not a product qualification. GRZAN frequently encounters confusion between the import business licence and the import item licence in project communications. The former targets the entity, remains valid long term once obtained and covers multiple items; the latter targets the product, one licence per product. Obtaining the import business licence does not automatically grant the right to import any product, and the reverse holds equally. Companies should therefore run the two as 2 parallel tracks in their scheduling rather than waiting for one to finish before starting the other.

Insight 2: Quality inspection facilities are the most common source of deficiency letters. Business premises and storage facilities are relatively easy to pass, whereas the configuration of quality inspection facilities and equipment is strongly tied to product characteristics: devices of different classes impose different requirements on inspection items and equipment precision. GRZAN recommends configuring inspection capability to the highest class among the products intended for import, rather than to the minimum needs of the first project, otherwise every step up to a higher-class item triggers a fresh change application.

Insight 3: The quality manager must be dedicated; concurrent roles are a common risk point. The import business licence requires a quality manager whose duty is to supervise compliance with quality standards and regulations. Where the same person also carries sales, purchasing or similar responsibilities, independence will be questioned during the on-site audit. GRZAN treats dedication as a hard verification item at the licence holder selection stage, not something to be confirmed later at application.

Insight 4: The import business licence and KGMP are two independent compliance lines. The import business licence targets the importing entity, while KGMP targets the manufacturing and quality system for Class 2 to 4 devices. A foreign manufacturer holding a KGMP certificate does not thereby satisfy the import business licence requirement of the Korean importing entity; conversely, an importing entity with an import business licence is not exempt from the KGMP requirements applicable to the product. For Class 2 to 4 products both must be in place simultaneously. When companies merge the two lines into one mental model, the most common consequence is tracking only the product-side KGMP expiry date while missing the maintenance and change of the entity-side licence, discovering only when the import business licence lapses that the entire import channel has already been cut.

4. Practical recommendations

• Confirm entity qualification before launching the item application. The import business licence and the item licence should proceed in parallel, but the latter should not be formally submitted before the former is secured.
• Configure quality inspection capability to the highest-class item. This avoids triggering a facility change each time a higher-class item is added later.
• Verify the quality manager appointment documents and presence status together. The dedication requirement must be maintained both at application and throughout the entire licence-holding period.
• Bring facility changes under change management. Changes to business premises or storage facilities affect the import business licence and should be managed separately from item-level changes to prevent omissions.
• Maintain a mapping ledger between the import business licence and the item licences. Managing entity qualification and product qualification on a single sheet significantly reduces the risk of missing expiries and renewals.

5. Verification checklist

• □ Business premises: verify the registered address against the lease and site photographs; the registered address matches reality and can receive inspections.
• □ Storage facilities: inspect the storage areas and conditions on site; they meet the storage requirements of the products intended for import.
• □ Quality inspection facilities and equipment: check the equipment list against calibration records; coverage spans the inspection items of the intended imported products.
• □ Quality manager: verify appointment documents, qualifications and presence status; the manager is dedicated and holds no incompatible concurrent roles.
• □ Licence and item correspondence: compare the import business licence against the import item licence ledger; both entity qualification and product qualification are in hand.
• □ KGMP independence check: determine KGMP applicability by class; for Class 2 to 4 a valid KGMP certificate has been obtained.
• □ Change linkage: check the notification records for premises and facility changes; changes were notified and no unreported change has occurred.
• □ 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