South Korea’s Ministry of Food and Drug Safety has set official approval guidelines for medical devices that use virtual reality and augmented reality technologies, setting a clearer development path for companies working to commercialize new products in this emerging space.

The Drug Ministry on Monday released a new regulatory guidebook laying down the definition and elements of VR and AR-based medical devices as well as approval standards, in the hope of expediting new related product development and commercialization processes.

According to the ministry, any AR or VR-incorporated product or software designed to prevent or treat an illness is recognized as a certified AR or VR-based medical device. 



Examples of products viewed as a medical device include software that transfers CT and MRI images into an AR-enabled computer for use in surgery, a VR headset that impacts brainwaves and electromyography to deliver rehabilitation effects, and a machine that uses medical images such as CT scans to develop a surgical plan or simulation.

Meanwhile, medical training exercise products, such as a program that helps nurses administer intravenous shots, or products designed to aid health such as one for enhancing memory, are not considered medical devices.

Korea’s drug regulators have yet to approve a medical device here that employs AR or VR technology. In the US, such devices aimed at rehabilitation have been approved by the local Food and Drug Administration.

More approvals of next-generation medical devices are expected down the road, as the ministry is currently finalizing related guidelines on smart diagnostic devices that use technologies like the internet of things, machine learning and big data analysis.

By Sohn Ji-young (jys@heraldcorp.com)