Entering the Indian medical device market presents a massive opportunity for companies. However, navigating the registration process can be demanding. This guide aims to a comprehensive understanding of the requirements involved in securing medical device registration in India. A successful registration process starts with understanding the legal s
Comprehensive Guide to Preparing A Plant Master File (PMF) For Medical Device Registration In India
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