Sri Lanka’s 2026 Medical Device Regulatory Registration

DDReg Knowledge Capsule · Jun 26, 2026 · 21m · transcript

In this episode, we explore the significant transformation of the medical device landscape in Sri Lanka under the mandate of the NMRA. We break down the risk-based classification system—from low-risk Class One items like bandages to the high-risk apex of Class Three devices like cardiac stents. Learn how international manufacturers can leverage the Global Recognition Pathway to fast-track approvals using existing Five Ten Kay clearances, M D R, or I V D R frameworks. We also dive into essential compliance requirements, including ISO thirteen four eight five quality systems and ISO fourteen…