NAVIGATING MEDICAL DEVICE REGISTRATION IN INDIA: A COMPREHENSIVE GUIDE

Entering the Indian medical device market presents a significant opportunity for businesses. However, navigating the approval process can be challenging. This guide aims to a comprehensive understanding of the requirements involved in obtaining medical device registration in India. A smooth registration process starts with comprehending the legal f

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices in accordance with the Medical Device Rules 2017 India. For medical device registration India on the Sugam portal, one essential requirement is the submission of a Plant Master File (PMF). This document provides detailed information about the legal manufactu