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

The process of registering a medical device with the Central Drugs Standard Control Organisation (CDSCO) can seem challenging. However, with a structured approach and understanding of the requirements, you can effectively navigate this process. This resource aims to furnish you with the necessary information to facilitate a successful registration … 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