Korea now Requiring Medical Device Manufacturers and Importers to Have Liability Insurance

This past summer, Korea issued article 43-6 of the Medical Device Act, requiring medical device manufacturers and importers to obtain liability insurance for patient claims of injury or death. For now, only manufacturers or importers of implantable device products are required to buy insurance. For patients that die from an implantable device, they can claim up to $100,000, for patients that are hurt up to $20,000, and for patients that are permanently disabled up to $100,000. Manufacturers and importers should purchase liability insurance before the sale of implantable devices. If a manufacturer or importer has a foreign insurance policy that covers sales in Korea and the liabilities above, no additional insurance is needed. In the future, this requirement is also likely to be expanded to non-implantable devices too.