NAVIGATING MEDICAL DEVICE APPROVAL IN INDIA

Securing regulatory approval for medical devices in India can be a complex process. Aspiring manufacturers are required to steer through a comprehensive regulatory structure governed by the Central Drugs Standard Control Organization (CDSCO). The approval pathway involves filing detailed submissions, meeting with stringent quality and safety specif

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