South Korea – South Korea’s MFDS publishes draft regulatory revision and new guidance documents

South Korea’s Ministry of Food and Drug Safety (MFDS) solicited public feedback on a draft revision to its medical device regulatory system that would, among other changes, introduce a separate category for software as a medical device (SaMD). The regulatory body also released a series of guidance documents on medical respirators, digital treatment devices, innovative medical devices and software, and medical device re-evaluation…