Liability Insurance for Human-Implantable Medical Devices in Korea

1. Key takeaways

Article 43-6 of the Medical Devices Act (insurance enrolment, etc.) was newly established by Act No. 18319, promulgated on 20 July 2021, and took effect on 21 July 2022 under the one-year-after-promulgation rule in Article 1 of the supplementary provisions. The obligated parties are the manufacturers and importers of medical devices implanted into the human body and continuously maintained for 30 days or longer (human-implantable medical devices), who must take out liability compensation insurance or join a mutual aid scheme. The threshold of applicability is the statutory definition of human-implantable, not a self-assessment of product risk level.

• The insured objects and insurance types are set by Article 12-5 of the Enforcement Decree (newly established 19 July 2022); coverage amounts and insurance timing are set by Article 12-6: KRW 150,000,000 for death, KRW 30,000,000 for injury and KRW 150,000,000 for permanent disability, with insurance completed by the day before the first sale, and enrolment and change information entered into the information system within 14 days and 3 days respectively.
• Partial exemptions exist for export-only devices and for cases where the overseas manufacturer already satisfies the insurance requirements.
• For Chinese manufacturers already in or planning to enter the Korean market, the obligation has been in force since 21 July 2022; it is a currently effective obligation, not a transitional arrangement, and belongs on the pre-market preparation checklist.

2. Legal basis

The insurance obligation, its amounts and its exemptions rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

3. Expert insights

Insight 1: The obligated parties are those who manufacture or import, not the licence holder exclusively. The statutory wording names the manufacturers and importers of such devices. On a pure import route, the obligation falls on the Korean licence holder side; where a factory exists in Korea, it falls on the manufacturing entity. GRZAN recommends defining the party responsible for insurance and the party bearing the cost in the licence holder agreement, to avoid the product reaching the market while the insured party has never been secured.

Insight 2: The test of applicability is whether the device is implanted and continuously maintained for 30 days or longer, not a self-assessment of risk. Article 43-6 limits the obligated parties to manufacturers and importers of human-implantable medical devices, meaning devices implanted into the human body and continuously maintained for 30 days or longer. The judgement rests on the product’s mode of use and dwell time, not on the company’s subjective risk evaluation, so it can be completed at the product definition stage, with no space for insuring later only after something happens. GRZAN recommends writing both questions into the product definition file as the sole criteria for whether insurance is required.

Insight 3: The three coverage amounts and the insurance timing are statutory figures with no room for self-selection. Article 12-6 of the Enforcement Decree sets the coverage amounts at KRW 150,000,000 for death, KRW 30,000,000 for injury and KRW 150,000,000 for permanent disability, and the insurance must be completed by the day before the first sale. A policy below any tier, or insurance completed later than the day before the first sale, fails the obligation. Enrolment and change information must also be entered into the information system, with entry deadlines of 14 days and 3 days respectively. GRZAN recommends writing the applicability threshold, three coverage tiers, completion deadline and system entry into one insurance verification sheet, managed in alignment with the validity periods of the item licence and the KGMP certificate.

Insight 4: The insurance obligation runs on a cycle independent of post-market compliance periods. The policy term of the liability compensation insurance does not automatically synchronise with the 5-year item renewal cycle or the 3-year KGMP certificate validity; each advances on its own cycle. GRZAN merges the insurance expiry date into the compliance calendar and re-checks the policy status whenever an item renewal or a KGMP periodic audit begins. When the three cycles are offset, the most common gap is a policy expiring before the licence, leaving the product still on sale while no longer meeting the insurance requirement.

Insight 5: The two exemption scenarios must be tested before insurance is taken out. Export-only devices and cases where the overseas manufacturer already satisfies the insurance requirements may be partially exempt. The order of judgement precedes insurance: first confirm whether the product is entirely for export, then confirm whether the overseas manufacturer has already insured under equivalent requirements and kept the evidence. GRZAN cautions that an exemption claim must have presentable written grounds, otherwise it will be treated as uninsured during verification at the licence and import stages. The evidence of export use and copies of overseas policies should be archived with the insurance certificates, and the judgement revisited whenever product use or the supply relationship changes.

4. Practical recommendations

• Complete the applicability judgement at the product definition stage. Judge by whether the device is implanted into the human body and continuously maintained for 30 days or longer; treat export-only devices and cases where the overseas manufacturer already satisfies the insurance requirements as partial exemptions, keeping written grounds on file.
• Define the insurance responsibility and cost bearing in the licence holder agreement, stating clearly the insured party, the renewal responsibility and the expiry reminder obligation.
• Insure at the statutory three-tier amounts and complete it by the day before the first sale. Check against Article 12-6 of the Enforcement Decree: KRW 150,000,000 for death / KRW 30,000,000 for injury / KRW 150,000,000 for permanent disability; verify the system entry deadlines of 14 days / 3 days.
• Merge the policy expiry date into the compliance calendar. Track it together with the 5-year item renewal and the 3-year KGMP cycle to avoid coverage gaps.
• Keep insurance certificates ready for verification. Policies and premium payment receipts are filed into the registration archive and managed alongside the licences.

5. Verification checklist

• □ Applicability judgement: determine whether the product is implanted into the human body and continuously maintained for 30 days or longer; the conclusion has written grounds.
• □ Insured party: confirm the obligated party by manufacturing or import route; consistent with the licence holder agreement.
• □ Insurance type: check against Article 12-5 of the Enforcement Decree; the insurance type conforms, and either liability insurance or a mutual aid scheme is in place.
• □ Coverage amounts: check against Article 12-6 of the Enforcement Decree; KRW 150,000,000 for death / KRW 30,000,000 for injury / KRW 150,000,000 for permanent disability, fully insured.
• □ Insurance timing: check the insurance completion date against the first sale date; insurance was completed by the day before the first sale.
• □ Renewal responsibility: review the licence holder agreement clauses; renewal responsibility and cost bearing are defined in writing.
• □ Certificate archiving: check the filing of policies and premium payment receipts; archived with the registration file and retrievable at any time.
• □ Information system entry: check the entry records for enrolment and change information; entered within the 14-day / 3-day deadlines with no overdue entries.
• □ Exemption grounds: check the evidence of export-only use or overseas manufacturer insurance; exemption claims have written grounds and are archived.
• □ 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