the Medical Devices Act, covers a medical-device manufacturer's or importer's liability to patients and institutions from device defects, side-effects or malfunction. It responds to risks specific to medical devices (clinical trials, FDA, EU CE).
N2N Insurance Brokerage does not represent any single insurer — it independently represents the client as an FSS-registered broker (Reg. No. 2026-012201). We compare the wordings, rates and service of AIG · Chubb · DB · Hyundai · KB · Meritz to propose the cover and price best suited to your risk. Each insurer's full wording is provided at application and binding.
Covers patient bodily harm and an institution's secondary loss from device defects, side-effects or malfunction. Unlike general PL, it separately covers a medical device's clinical trials, certification and post-market surveillance risks.
K-GMP-certified firms
Importing and selling overseas brands
IVD and wearables
| Clinical-trial stage | Phase I–IV trials |
|---|---|
| Global extension | FDA·CE·PMDA |
| Post-Market | Post-market surveillance & adverse events |
| Policy period | 1 year (Claims-Made) |
|---|---|
| Insurers | Hyundai |
| Limits | Per claim KRW 1–50bn |
| Turnaround | 3–6 weeks |
KRW 20m–1bn per year depending on revenue and risk grade.
If the insured event has already occurred at the time the contract is made, the contract is void. However, where the contract is void due to the company's intent or negligence, or where the company knew or could have known of the nullity before acceptance yet did not refund the premium, the company refunds the premium with interest at the policy-loan rate published by the Korea Insurance Development Institute, compounded annually, for the period from the day after payment to the day of refund.
The specific losses not covered (exclusions) are set out in each insurer's policy wording and product description; on this page, see the “Cover” tab(or the “Losses not covered” section) for the main exclusions. For other cover-specific grounds on which claims are not paid, please refer to the policy wording.
The company provides cover, in accordance with the policy, from the time it accepts the application and receives the first premium. Where the company accepts the application after receiving the first premium with it, cover also begins from the time the first premium was received.
The application must be completed by the policyholder, and the policyholder and the insured must sign it by hand. Failure to sign by hand may result in disadvantages regarding the validity of the contract. On an internet cyber-mall, an electronic signature may be used instead.
The policyholder has the right to be given and have explained the information needed about the product they wish to buy.
The insurer and N2N Insurance Brokerage must explain the important matters of the product to ordinary financial consumers.
When applying, the policyholder, the insured or their agent must disclose truthfully the facts they know regarding the questions in the application (including the questionnaire). Otherwise the claim may be declined or the contract cancelled. Where insurance is taken out by telephone or other means of communication, the duty is performed by answering the seller's questions, which are recorded, without a separate written questionnaire, so answers must be given with particular care.
If, after the contract is made, any of the following arises in respect of the subject-matter insured, the policyholder or the insured must notify the company in writing without delay and obtain endorsement on the policy.
The surrender value is the amount paid if the contract is cancelled early. Unlike bank savings, insurance combines risk protection and savings: part of the premium is paid out as claims to other policyholders who suffer accidents, and part covers the insurer's operating expenses, so the surrender value on early cancellation may be less than the premiums paid, or nil.
Under Article 59-4(1) of the Income Tax Act (special tax credit), for protection-type insurance taken out by an employee only, a tax credit of 12% of the premium paid (capped at KRW 1 million per year) is available. Tax matters may change with amendment or repeal of the relevant tax law.
Except as provided by law, the insurer and N2N Insurance Brokerage do not collect, use, inspect or provide personal data related to this contract — for its conclusion, maintenance and claim payment — without the consent of the policyholder, the insured or the beneficiary. However, for those purposes the insurer may, with the consent of the policyholder and the insured and in accordance with law, provide personal data to other insurers and insurance-related bodies.
The above is a summary and excerpt of the policy wording; for grounds on which claims are not paid and other details, please refer to the policy wording and product description.
Common risk patterns in the medical-device business — a five-scenario self-check
Defects, side-effects or malfunction in a medical device translate directly into bodily harm to the patient using it, creating manufacturer liability.
Imported devices also bear liability risk for defects or side-effects occurring in Korea.
For IVD and wearable devices, the accuracy of the result affects patient care, so a separate risk assessment is needed.
Clinical-trial-stage risk is treated differently from general PL and must be designed under a separate wording.
Post-market surveillance and adverse-event response after launch are also part of medical-device risk management.
Medical device liability insurance starts from a different point than general product liability (PL). Because a device acts directly on the body, a defect, side-effect or malfunction leads straight to patient harm and can spread to secondary loss for the institution. Medical-device risk also does not arise only after launch: it is distributed across the product lifecycle — the clinical-trial stage, approval (FDA, CE, domestic certification), and post-market surveillance and adverse-event reporting. So medical device liability insurance handles clinical-stage risk separately and treats use outside the approved scope, or gross negligence by clinicians in use, as exclusions.
Source: (standard insurance-textbook scenario)
The wording and structure points decision-makers most often overlook
Clinical-trial-stage risk is usually handled separately from general device PL. If you have a product in development, check that clinical-stage cover is designed separately.
Loss arising from clinicians using a device outside its approved scope, or from gross negligence in use, is excluded. Understand the boundary between the manufacturer/importer's responsibility and the user's.
Post-launch adverse-event and recall-type response is a separate endorsement area. Check whether post-market surveillance cover is included.
The questions asked most when considering medical device liability insurance
Where general product liability (PL) broadly covers loss from product defects, medical device liability insurance — reflecting that a device acts directly on the body — separately addresses risks across the product lifecycle such as clinical trials, certification and post-market surveillance.
Importing and selling overseas-brand devices also carries liability risk for defects or side-effects occurring in Korea, so it is within scope.
Clinical-trial-stage risk is usually handled under a separate wording from general device PL. If you have a product in development, check that clinical-stage cover is designed separately.
Loss from off-scope use or gross negligence in use by clinicians, the inherent risk of the trial itself, and wilful or fraudulent acts are excluded.
Post-launch post-market surveillance, adverse-event response and recall-type response are a separate endorsement area. Check whether that cover is included.
The insurer calculates it based on product type and risk grade, revenue, clinical stage and whether sold overseas, the limit and endorsement structure, and past adverse-event and recall history. The exact premium and terms are confirmed after underwriting by insurers such as AIG, Chubb, DB, Hyundai, KB and Meritz.
