CONQUERING MEDICAL DEVICE APPROVAL IN INDIA

Securing official approval for medical devices in India can be a multifaceted journey. Aspiring manufacturers must steer through a rigorous regulatory structure governed by the Central Drugs Standard Control Organization (CDSCO). The approval pathway involves presenting detailed submissions, complying with stringent quality and safety specification

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