MFDS Holds Seminar on Technical Support for Innovative Medical Devices Including Digital Therapeutic Devices

The Ministry of Food and Drug Safety announced on the 27th that it will hold a technical support seminar at COEX in Seoul to support the rapid commercialization and export of innovative medical devices, focusing on digital therapeutics and in vitro diagnostic medical devices.

The seminar will discuss topics such as how to prepare clinical trial protocols for digital therapeutics and in vitro diagnostic medical devices in Korea, the clinical trial system of the U.S. Food and Drug Administration (FDA), the clinical trial process for software medical devices, and overseas clinical trial cases.

This seminar is aimed at companies related to innovative medical devices and those interested in domestic and international medical device clinical trial systems.

An official from the Ministry of Food and Drug Safety stated, “We expect this seminar to help strengthen the expertise of domestic digital therapeutics and in vitro diagnostic medical device industry practitioners, support the rapid commercialization of innovative products, and enhance capabilities for entering overseas markets.”

Meanwhile, the Ministry is conducting the 3·3·3 project to help the industry rapidly commercialize innovative medical devices and export them overseas. It provides focused support over three years for 30 items in three product groups capable of creating new global demand among ‘K-medical devices’: digital/newly developed/innovative medical devices, in vitro diagnostic medical devices, and imaging diagnostic equipment.

This content was produced with the assistance of AI translation services.