Securing official approval for medical devices in India can be a demanding process. Aspiring manufacturers need to traverse a comprehensive regulatory structure governed by the Central Drugs Standard Control Organization (CDSCO). The approval course involves presenting detailed applications, adhering with stringent quality and safety standards, and
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