The medical device industry in India is experiencing rapid growth. This presents both challenges and rewards. To participate successfully, manufacturers need to conform with the stringent regulations set by the Central Drugs Standard Control Organization (CDSCO). This article provides a comprehensive overview of the process for registering medical
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