Navigating the regulatory landscape for medical devices in India

In recent years, India’s medical device industry, a critical component of the healthcare sector, has experienced significant regulatory transformation.

The introduction of the Indian Medical Device Rules in 2017 and subsequent amendments have reshaped the industry’s land-scape, presenting various challenges and opportunities for manufacturers. This article offers a comprehensive overview of the current regulatory frame-work, the role of the Central Drugs Standard Control Organization (CDSCO) and the implications of these regulations for in-novation, market-entry, and compliance, particularly in light. of recent concerns with regard to surrounding high-risk devices.

Please refer to the below document to read the full article by Sidharrth Shankar, published in Express Healthcare.