Entering the Indian medical device market demands a thorough understanding of its stringent registration process. To guarantee regulatory compliance and market access, manufacturers must navigate a intricate system. This involves submitting detailed applications to the Central Drugs Standard Control Organisation (CDSCO) along with requisite technic… Read More

The adventure of registering a medical device with the Central Drugs Standard Control Organisation (CDSCO) can seem daunting. However, with a thorough approach and understanding of the requirements, you can successfully navigate this process. This resource aims to offer you with the necessary information to guarantee a smooth registration experienc… Read More

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… Read More