Medical Device Guidelines for South Korea.

Posted by Neha Mate on August 21st, 2018

Nowadays the companies working to commercialise VR and AR products provided by the newly approved guidelines.

If you are the manufacturer and want to sell the medical device in South Korea's by importing or developing them. Then this guidelines surely help you out.

For South Korea's medical device official approval guidelines have set by the Ministry of Food and Drug Safety in South Korea nation. They set a clearer development path for companies working to commercialise new products in this emerging space.

The new guidebook is released by the Drug Ministry which includes 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 commercialisation processes.

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 finalising related guidelines on smart diagnostic devices that use technologies like the Internet of Things, machine learning and big data analysis.