* The contents below is subject to change in the future.

According to the implementation of the medical device insurance regulation (‘22.7.21.), manufacturers/importers of implantable medical devices must have the medical device liability insurance or similar insurance.

- As of the enforcement date (’22.7.21.), companies that already manufacture or import implantable medical devices must be done  by January 20, 2023.

- Companies that have been approved for implantable medical devices after the enforcement date must have the insurance prior to  sales

For the insurance, input the insurance certifcate information on MFDS website.