Blogs

Overview The International Medical Device Regulators Forum (IMDRF) continues its mission to harmonise and strengthen global medical device regulations. By accelerating international regulatory convergence, IMDRF aims to build a more efficient, effective, and responsive global...

Introduction The Central Drugs Standard Control Organisation (CDSCO) has recently updated its regulatory framework to streamline the role of subsequent importers of medical devices in India. This move directly impacts manufacturers, authorized representatives, and distributors...

Introduction The European regulatory landscape is evolving once again. With the upcoming MDCG 2025 guidance, medical device manufacturers face a major shift in how post-market vigilance is managed. Trend reporting — once seen as optional...