Liability insurance coverage for implantable medical devices (i.e., products that last more than 30 days in the body) has become mandatory as of January 20, 2023
작성자 관리자날짜 2023-03-01 10:12:37조회수 149
Liability insurance coverage for implantable medical devices (i.e., products that last more than 30 days in the body) has become mandatory as of January 20, 2023. As a background, the Medical Devices Act was amended on July 21, 2022 to impose obligations on medical device importers or manufacturers, while a six-month grace period was granted for the previously approved products, which took effect on January 20, 2023.
The purpose of the obligatory mandatory liability insurance is to "ensure that the medical device manufacturer or importer can stably compensate for the patient's damage in the event of damage caused by side effects from the use of the medical device."
Manufacturers and importers of implantable medical devices are required to purchase liability insurance for their products. But in the case of an importer, if the overseas manufacturer has already subscribed to liability insurance that meets the following two conditions, the domestic importer is not required to enter into such liability insurance.
- Liability Insurance from the manufacturer should also cover domestic patients in Korea.
- The scope of compensation (KRW 150 million for death, KRW 30 million for injury, KRW 150 million for aftereffects, etc.) must be satisfied.
In Korea, there are about 12 insurance companies that offer such liability insurance, and insurance subscription fees/costs are known to increase in proportion to the expected sales volume domestically.
In addition, documentation showing proof of subscribed liability insurance (name of insurance company, terms and conditions of insurance contract, policyholder, insurance amount, expiration date, etc.) is required to be submitted to the Ministry of Food and Drug Safety three days before the product is imported.
Accordingly, we expect that the cost of maintaining the product registration will increase gradually if the company designates and operates a distributor as a license holder without an operational Korean subsidiary. If you have any questions regarding the liability insurance, please do not hesitate to contact MDREX (pro@mdrex.co.kr).