South Korea – Updates: Innovative device designations, IVD Act enforcement

Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for manufacturers.

Changes to MFDS process for designating innovative devices

First, the South Korean Ministry of Food and Drug Safety (MFDS) has issued a draft revision (link in Korean) to regulations on procedures for designating innovative medical devices. The revision would establish a basis for application periods whereby South Korean market registrants may request designation of their products as innovative devices…