CONQUERING MEDICAL DEVICE APPROVAL IN INDIA

Securing regulatory approval for medical devices in India can be a multifaceted undertaking. Aspiring manufacturers are required to navigate a stringent regulatory framework governed by the Central Drugs Standard Control Organization (CDSCO). The approval pathway involves filing detailed submissions, adhering with stringent quality and safety stand

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