Insights

In vitro diagnostic (IVD) medical devices play a crucial role in healthcare by helping detect diseases, monitor health conditions, and guide treatment decisions. Given their impact on patient safety and public health, regulating these devices is essential. India’s Medical Devices Rules of 2017 introduced a structured framework for classifying IVD devices based on risk. This classification determines the regulatory requirements manufacturers must meet before marketing their pr

The Post-Market Surveillance and Periodic Safety Update Report (PSUR) process plays a critical role in ensuring the ongoing safety and performance of medical devices in India. Since the implementation of the Indian Medical Device Rules (MDR) 2017, manufacturers and importers must comply with specific requirements for PSUR submission. This blog post explains the PSUR procedure as per the Indian MDR 2017, its applicability to both new and legacy medical devices, and the frequen

Obtaining a test license for medical devices in India is a crucial step for manufacturers and importers who want to ensure their products meet regulatory standards before full-scale production or marketing. The Indian Medical Device Rules 2017 set clear guidelines for this process, and the NSWS (National Single Window System) portal has streamlined the application procedure. This guide walks you through each step to help you secure your test license efficiently and without co