Ministry of food and drug safety

Ministry of food and drug safety

home > Information > News&Notice > News&Notice
News&Notice|News&Notice|Information|Minisry of Food and Drug Safety

News&Notice

[Press Release, Aug. 31] Development of Management System for Softwares as Medical Device
  • Registration Date 2020-09-08
  • Hit 384
[Press Release, Aug. 31 / Unofficial translation]



Development of Management System for Softwares as Medical Device
- New system is devised for the classification of medical devices which employ AI, VR and AR technologies -


□ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) issued an administrative pre-announcement of the draft revision of the “Regulations on Medical Device Products and Classification,” which mainly deal with the establishment of new product classification for medical softwares.

○ The recent revision was conducted in an attempt to develop a new medical device classification system necessary for the efficient management of softwares as medical devices.


□ Main contents of the revision include the addition of ▲ 1 large category: (E) Software ▲ 11 sub-categories including software for cardiovascular diagnosis ▲ 90 product items including software for cardiovascular imaging and treatment planning
※ (as is) 8 items including preexisting medical picture archiving and communication system software → (after revision) expand classification system with 90 detailed product items

○ 11 sub-categories are classified according to clinical field such as cardiovascular, dental, and neurological medicines. 90 product items have been categorized* in consideration of potential risks to human health. New classification system was designed after a comprehensive review of necessary measures.
* Classification of medical devices according to the level of potential risk to human body


□ The MFDS expects that the draft revision will not only render support for Korean companies that wish to export their products to the U.S. and other countries that are already approve and manage such medical devices to advance into foreign markets but also set up a foundation for the “establishment of smart medical infrastructure,” which is one of the tasks of the Korean New Deal.

○ The Ministry said it will constantly refine medical device management systems utilizing AI, VR, AR and other types of cutting-edge technologies and spare no effort in the protection of the people’s health.

○ For your reference, more details of the pre-announcement of the “Regulations on Medical Device Products and Classification” is available on the MFDS website. (http://www.mfds.go.kr > Law/Data > Legal information > Public Notices, Directives, Established Rules)
Attached File Attach all down
  • 8.31 Development of Management System for Softwares as Medical Device.pdf Download

Division 국제협력담당관

Written by 배성명

Telephone 043-719-1559