Introduction to the Requirement on Liability Management Measure for Human Implantable Medical Device

작성자 MDREX 날짜 2024-02-06 18:16:05 조회수 32

It has been a year (from January 2023) since the mandatory liability insurance enforcement for human implantable medical devices has been introduced. The background for this enforcement was that there were cases where defects of human implantable medical devices have caused damages to patients, but the compensation was not properly made due to company’s bankruptcy, etc. Therefore, MFDS decided to revise the Medical Device Act to confirm the minimum capacity of compensation for liabilities by requiring the submission of a certificate of liability insurance before selling medical devices.


However, it has been pointed out that liability insurance is very costly with limited coverage. Thus, two organizations representing medical device companies (the Korea Medical Devices Industry Association and the Korea Medical Devices Association) began operating mutual aid associations (October 2023). The mutual aid associations collect funds in proportion to sales revenue from each member company, and the funds are firstly used to compensate patients if any accident occurs on behalf of the member company in issue. The associations also work on to increase the fund through various for-profit businesses.


Neither of organizations has many member companies or funds collected, so the project has not been yet materialized. However, considering that the mutual aid associations are run by representing organizations and economic burden that liability insurance will bring, we recommend joining a mutual aid association fund through a Korean license holder if liability insurance does not cover liabilities in Korea.


MDREX does provide a total solution for successful market access by supporting from market entry strategy build-up to reimbursement. Especially for global companies and overseas manufacturers who are seeking for a license holder in Korea, acting as a local representative with regulatory expertise, we obtain and hold legitimate licenses as well as respond to compliance issues on timely manner.


Therefore, if you have any questions about Korean regulations or interested in further discussion with MDREX, please feel free to contact us at


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