Korea Targets Innovative Devices

Korea’s Ministry of Food and Drug Safety is implementing a Special Act for Innovative Devices that will include 3D-printed devices, medical devices that use artificial intelligence and big data, genetic testing devices, and intelligent robots, among other innovative products.

The act’s main features include an expedited review process, a customized safety management system, technical support for clinical trials and capacity building.

Korea also introduced an IVD Act to address the unique characteristics of IVDs. For example, it provides for a simultaneous review for companion diagnostics and drugs. It establishes a clinical laboratory accreditation program and approval system for IVDs that allows for advanced genetic testing following accreditation.