Import Declaration and Customs Clearance for Medical Devices in Korea

1. Key takeaways

Declaration and release of imported medical devices in Korea presuppose that the product has already obtained its import item licence, and release is conditioned on label and UDI information being consistent with the IMDIS database. The former is a question of entity and product qualification; the latter is a question of data consistency.

• UDI requirements now cover all classes in phases: Class 4 from 1 July 2019, Class 3 from 1 July 2020, Class 2 from 1 July 2021 and Class 1 from 1 July 2022. All classes of devices are therefore within UDI coverage at import today, and there is no room for lower-class devices to postpone labelling.
• GRZAN’s pre-clearance self-check has 4 items: validity and scope of the item licence; label content items and Korean-language expression; consistency between UDI labelling and IMDIS data; and alignment of importing entity qualification with import records.
• Most customs hold-ups stem not from the customs authorities themselves but from data inconsistency, which is a preventable item rather than an unavoidable one.
• Since 15 September 2026, the Medical Devices Act provides a statutory channel for cross-checking customs-side and medical-device-side import data, eliminating the earlier room for inconsistent records on the two sides to go unnoticed.

2. Legal basis

The declaration, labelling and UDI obligations rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

3. Expert insights

Insight 1: Most clearance blockages occur not at customs but in data inconsistency. In the import obstruction cases GRZAN has handled, the problem usually lies in UDI data not matching IMDIS records, or IMDIS records not matching the actual labels, rather than in a missing document. Data inconsistency is preventable: comparing the IMDIS records field by field against the actual labels before shipment eliminates most blockages. This verification should be a fixed routine action, not a remedial one after problems arise.

Insight 2: The scope of the item licence matters more than the mere existence of a licence. Import item licences are issued per item or item group, and the models actually imported must fall within the licensed scope. Shipping new models or modified specifications without updating the item licence creates a compliance gap of holding a licence yet exceeding its scope. GRZAN recommends re-checking the licensed scope against the list of models to be shipped after every model change and item group adjustment, and keeping the check record together with the shipping documents. The check itself is not complicated; the difficulty lies in persistence. Fixing it as a mandatory pre-shipment step costs far less than remedying a change application afterwards.

Insight 3: Manufacturer and importer information in UDI data is a dynamic item, not a static one. UDI data must be updated in step when the licence holder changes or the licence is transferred. If a company changes its KLH but only completes the licence-level change without revising the UDI data, the importing entity shown in the licence will diverge from the entity shown in the UDI data at import. This linkage is the most easily overlooked in practice, because the two tasks usually sit with different teams.

Insight 4: Import records and distribution record reports must reconcile. The quantities, lot numbers and dates formed at import are the foundation of the subsequent distribution record reports. Inconsistent bases between the two will surface in post-market inspections. GRZAN recommends collecting data according to the report fields from the very first shipment, rather than reconstructing it backwards from logistics systems afterwards.

Insight 5: Declarations go to the Korea Medical Device Safety Information Institute, and customs data now has a statutory comparison channel. Article 30(3) of the Enforcement Rule provides that import declarations are submitted to the head of the Korea Medical Device Safety Information Institute, and the exemptions from import declaration and the issuance of confirmation letters under Article 32 follow MFDS public notices. From 15 September 2026, Article 32-3 of the Medical Devices Act allows the MFDS Commissioner to request the Commissioner of the Korea Customs Service to provide import declaration data under Article 241 of the Customs Act. This means customs-side and medical-device-side import data can now be cross-checked directly, and the previous room for inconsistent bases on the two sides to go undetected no longer exists. The items, quantities and entity information declared at import must match the licence and UDI data exactly.

4. Practical recommendations

• Establish a pre-shipment UDI consistency check. Before every shipment, compare the IMDIS records against the actual labels field by field and keep a record.
• Check that the models to be shipped fall within the item licence scope. Re-check after every model or specification change to avoid holding a licence while exceeding its scope.
• Bind licence holder changes and UDI data updates into a single task. Completion of the licence change triggers the UDI data revision at the same time.
• Collect data according to the distribution record report fields from the first shipment. Quantities, lot numbers, expiry dates and dates follow the reporting basis uniformly.
• Maintain a traceable archive for every import shipment. Item licence, label specimens, UDI records and import documents are filed together for later inspections.

5. Verification checklist

• □ Item licence validity: verify the licence validity period; within the validity period, not suspended or revoked.
• □ Scope matching: compare the models to be shipped against the licensed item scope; all models fall within the licensed scope.
• □ Labelling: check the labelling items on containers, outer packaging and instructions for use; accurately and clearly labelled in Korean with all items present.
• □ UDI labelling: check the physical UDI against the IMDIS records; codes and data fields match completely.
• □ Manufacturer and importer information: check the entity information in IMDIS; consistent with the current licence holder.
• □ Importing entity qualification: verify the validity of the import business licence; the licence is valid and the entity matches the licence holder arrangement.
• □ Import record fields: check the collected fields against the distribution record reporting basis; quantities, lot numbers, expiry dates and dates reconcile.
• □ 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