Entering the Indian market for medical devices presents a unique scenario for manufacturers. To successfully operate in this growing sector, it's crucial to comply with the regulatory framework set by the Central Drugs Standard Control Organization (CDSCO). The CDSCO registration process can seem daunting, but by following Morulaa a structured appr
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