South Korea regulations on IVD medical devices to go into effect in 2020

Regulations on in-vitro diagnostic (IVD) medical devices expected to go into effect in 2020 in South Korea will establish a broad set of registration requirements for IVDs as part of a push to improve oversight of their safety and quality, according to the country’s Ministry for Food and Drug Safety.  The regulations, the first in South Korea to specifically address the growing IVD medical devices market, will also mandate approved procedures for conducting clinical reviews of IVD devices, as well as certification requirements for hospitals and laboratories conducting IVD testing and labeling guidelines.