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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…
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