What is the Ministry of Food and Drug Safety's approval/licensing test?

Devices, instruments, materials, etc. used alone or in combination for the purpose of diagnosis, treatment, alleviation, management, or prevention on humans or animals as defined in Article 2 of the Medical Devices Act.
This is an official test conducted in accordance with the notifications and guidelines required by the Ministry of Food and Drug Safety for products that exert physical effects inside and outside the body.