Import Item Licence Versus Manufacturing Item Licence in Korea

1. Key takeaways

The import item licence and the manufacturing item licence apply the same set of class classification and review standards. Classes are determined under Article 3 of the Medical Devices Act and Attached Table 1 of the Enforcement Rule, and the statutory review periods are identical: Class 1 takes 5 working days; Class 2 takes 25 working days initially and 15 working days for changes; Class 3 and Class 4 take 55 working days without clinical data and 70 working days with clinical data.

• The real differences lie in 3 dimensions: the applicant differs (importing entity versus manufacturing entity); the KGMP audit target differs (the import route audits the overseas manufacturing site); and the bearer of post-market obligations differs (on the import route the licence holder bears them).
• For a single company that both manufactures in and imports into Korea, two licences for the same product will coexist, and their changes and renewals must be managed separately.
• Identical review standards do not mean identical dossier composition: the KGMP stage diverges sharply, since the import route requires an on-site conformity audit of the overseas manufacturing site.

2. Legal basis

The classification rules, review periods and renewal obligations rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

3. Expert insights

Insight 1: Identical review standards do not mean identical dossier composition. Matching classes and review periods easily lead companies to assume that switching routes only means switching the applicant. The actual difference appears at the KGMP stage: the import route requires a KGMP conformity audit of the overseas manufacturing site, while the manufacturing route audits sites inside Korea. Audits abroad involve representative model selection, audit scheduling and translation arrangements, and their preparation period is not on the same scale as a domestic audit (the specific duration is a practical estimate and varies with the location of the manufacturing site and the audit body’s schedule).

Insight 2: Renewal dates diverge, so separate ledgers are required. Article 49 of the Medical Devices Act provides that manufacturing licences, manufacturing certifications, manufacturing notifications, import licences, import certifications and import notifications, 6 categories in total, must all be renewed every 5 years. Because the first-issuance dates on the import and manufacturing routes for the same product usually differ, the two 5-year windows are offset from each other. GRZAN builds the ledger on the principle of one product, one licence, one expiry date, rather than one ledger per product, to avoid renewing only one of the two routes.

Insight 3: Change triggers differ, and one modification may affect only one side. Technical modifications such as a change of manufacturing site or of raw materials do not affect the two routes symmetrically. A change of the overseas manufacturing site hits both the KGMP status and the item licence on the import route, whereas adding a manufacturing line inside Korea may not touch the import route at all. GRZAN’s approach is to first locate which step the modification occurred at and then determine which licence is affected, rather than treating everything uniformly as a product change.

Insight 4: The post-market obligation bearers differ, so incident reporting cannot run on one line only. On the import route, the licence holder handles MFDS liaison and incident reporting coordination; on the manufacturing route, the manufacturing entity bears them. Where both routes exist for the same product and reporting responsibility has not been divided in advance, duplicate reports or mutual non-reporting can easily occur. This division should be written simultaneously into the licence holder agreement and internal SOPs, with a single designated lead. In projects where both routes coexist, GRZAN typically places the lead on the licence holder side, which holds the post-market information, while the manufacturing entity supplies technical information within agreed deadlines, preventing reporting inconsistencies caused by information asymmetry.

4. Practical recommendations

• Determine the route first, then the class. The classification rules for the manufacturing and import routes are identical, but the documentation and audit arrangements differ, so the route conclusion must come first.
• Maintain a separate renewal ledger for each licence. Record expiry dates by licence rather than by product, covering all 6 categories of renewable authorisations.
• Schedule the overseas KGMP audit on the longest preparation scenario. The on-site audit on the import route involves cross-border coordination and should be started at the same time as the item application.
• For changes, locate the affected step first, then the affected licence. Build a mapping table from modification step to affected licence to prevent omissions.
• Where both routes coexist, divide post-market obligations in writing. The lead party, deadlines and information-synchronisation method for incident reporting must be specified down to individuals.

5. Verification checklist

• □ Route determination: manufacturing route or import route; the conclusion is traceable to the identity of the applicant.
• □ Class determination: check against Article 3 and Attached Table 1 of the Enforcement Rule; the class conclusion is consistent and does not vary with the route.
• □ Statutory review period: check the Enforcement Rule attached tables by class; the working-day basis is used.
• □ KGMP audit target: confirm whether the audit site is domestic or the overseas manufacturing site; consistent with the route, certificate valid for 3 years.
• □ Renewal ledger: record 5-year expiry dates by licence; every licence has its own expiry date record.
• □ Change impact scope: map modifications to affected licences; no omissions and no duplicate notifications.
• □ Post-market obligation bearer: check the responsible parties for incident reporting and MFDS liaison; the division of responsibility is documented with no vacuum.
• □ 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