Medical Devices

Enforcement Rules on the In-Vitro Diagnostic Devices Act (140 page(s), in Korean)

The In-Vitro Diagnostic Devices Act, which is the primary legislation of the enforcement rules, was enacted in an aim to establish an independent IVD devices management system that is more in line with the characteristics of IVD devices.  The enforcement rules were prepared accordingly prescribe the classification criteria and the procedures and methods for approval, certification and reports of in-vitro diagnostic medical devices needed to implement the Act.