Entering the Indian medical device market presents a massive opportunity for businesses. However, navigating the approval process can be challenging. This guide provides a thorough understanding of the requirements involved in obtaining medical device registration in India. A smooth registration process starts with understanding the legal structure

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