Regulations on in-vitro diagnostic (IVD) products in South Korea that took effect in May establish a broad set of registration requirements as part of a push to improve oversight of their safety and quality.
The regulations, the first in South Korea to specifically address the growing IVD market, also mandate approved procedures for conducting clinical reviews of IVDs, as well as certification requirements for hospitals and laboratories conducting IVD testing and labeling guidelines. Under a new classification system established by the Ministry for Food and Drug Safety, IVDs will be separated into four categories, based on their potential risk.