NAVIGATING THE CDSCO MEDICAL DEVICE REGISTRATION PROCESS IN INDIA

Entering the Indian market for medical devices presents a unique scenario for manufacturers. To successfully distribute in this growing sector, it's crucial to navigate the regulatory framework set by the Central Drugs Standard Control Organization (CDSCO). The CDSCO registration process can seem daunting, but by following a structured approach and

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