ROLE OF A QUALITY MANAGEMENT SYSTEM(QMS) IN POST-MARKET SURVEILLANCE
INTRODUCTION The medical device industry has an essential responsibility to ensure that devices remain safe and effective throughout their lifecycle. While clinical trials and pre-market assessments play a critical role in proving the safety and performance of medical devices, post-market surveillance (PMS) ensures that products continue to meet the highest standards once they are available […]
SOUTH KOREA’S NEW MEDICAL DEVICE GMP REGULATIONS FORMALLY PUBLISHED
SEOUL, February 2026 — The Ministry of Food and Drug Safety (MFDS) has formally published the updated Medical Device GMP Regulations, marking a significant overhaul in how medical devices are manufactured, imported, and monitored in South Korea. These regulations, effective throughout 2025 and 2026, introduce specialized standards for digital health and artificial intelligence while harmonizing […]