Korea eases approval, licensing review of AI-based medical devices

Continuing its push to encourage the development of artificial intelligence (AI) products, South Korea is making it simpler for manufacturers to secure government approval of AI-based medical devices. In October, the Ministry of Food and Drug Safety announced that it would ease the guidelines on 154 such devices.

The Korean government will also provide information for designing clinical trials of AI-based medical devices and facts on product approval, follow-up management, and product development.