Unlocking the Indian Market: A Guide to the 2017 and 2023 Device Rules

This episode provides a deep dive into India's Medical Device Rules, 2017, and the subsequent amendments through 2023. We explore the shift to a risk-based classification system, new Quality Management System (QMS) and licensing requirements, and the critical role of the Central Drugs Standard Control Organization (CDSCO). The discussion covers practical implications for manufacturers, including post-market surveillance, vigilance, and the latest 2023 updates to the regulatory framework. • What were the landmark changes introduced by the Medical Device Rules, 2017? • How does India's risk-based classification system (Class A-D) impact your device's path to market? • What are the new Quality Management System requirements for manufacturers? • How has the licensing process changed, and what is the role of the India Authorized Agent? • What are your post-market surveillance and vigilance responsibilities under the current rules? • What specific updates were made in the June 2023 amendment? • Is your foreign manufacturing site subject to inspection by the CDSCO? • How do you navigate the SUGAM online portal for submissions? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide, including India. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.