1. Reasons for Amendment

  This amendment aims to prescribe matters delegated by the Act, such as the type, subscription object, and amount of coverage of insurance or mutual aid to which manufacturers/importers must subscribe for patient damage caused by medical devices according to the amendment (Act No. 18319; partially amended on July 20, 2021, and enforced on July 21, 2022) of the Medical Devices Act.

2. Major Provisions

A. Introduction of mandatory medical device liability insurance (or mutual aid) system (Articles 12-5 and 12-6 newly inserted)

  1) As the Medical Device Act was revised (Act No. 18319; partially amended on July 20, 2021, and enforced on July 21, 2022) to make it mandatory for manufacturers/importers of medical devices that may cause death or serious side effects to patients to obtain liability insurance (or mutual aid) so that patients can be compensated for damage caused by medical devices, it is necessary to stipulate the type, subscription object, amount of insurance coverage, and other necessary matters of insurance or mutual aid as prescribed by the Presidential Decree.

  2) Stipulate that manufacturers/importers of implantable medical devices shall be subject to insurance or mutual aid and that the type of insurance or mutual aid shall be liability Insurance for medical device or insurance or mutual aid containing the same, and specify the amount of insurance coverage classified by death, injury, and after-effect disability.

  3) It is expected that this amendment will ensure legal clarity by clearly stipulating the subscription object, type, amount of insurance coverage, etc. of insurance or mutual aid and further, enable the stable operation of the mandatory medical device liability insurance system.