NAVIGATING MEDICAL DEVICE REGISTRATION IN INDIA: A GUIDE TO CDSCO COMPLIANCE

The pharmaceutical device industry in India is experiencing rapid growth. This presents both thrills and rewards. To participate successfully, manufacturers need to adhere with the stringent regulations set by the Central Drugs Standard Control Organization (CDSCO). This article provides a comprehensive overview of the process for registering medic

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