Securing official approval for medical devices in India can be a multifaceted process. Aspiring manufacturers must navigate a comprehensive regulatory system governed by the Central Drugs Standard Control Organization (CDSCO). The approval course involves filing detailed requests, meeting with strin

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 provi