Securing regulatory approval for medical devices in India can be a multifaceted journey. Aspiring manufacturers need to steer through a stringent regulatory structure governed by the Central Drugs Standard Control Organization (CDSCO). The approval pathway involves presenting detailed requests, meeting with stringent quality and safety standards, a
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