South Korea has updated its medical device regulations to provide a pathway for innovative technologies such as artificial intelligence, robotics and 3D printing technology applied to medical devices.
The new regulations, which take effect on May 1, 2020, include pre-market review criteria for devices with advanced and innovative technologies. The new pathway includes several mechanisms for fast tracking approvals for innovative devices, including breakthrough devices that improve treatment for rare or intractable diseases, and priority reviews.
The regulatory authority will provide additional support during the development and licensing phase. The pathway also includes a five-year post-market surveillance program.