UNDERSTANDING MEDICAL DEVICE REGISTRATION IN INDIA

Entering the Indian medical device market demands a thorough understanding of its stringent registration process. To guarantee regulatory compliance and market access, manufacturers need to navigate a multifaceted system. This involves submitting comprehensive applications to the Central Drugs Standard Control Organisation (CDSCO) along with necess

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