Startup Incubation and Innovation Centre, IIT Kanpur for a brainstorming session- ‘Medical Device Pathway in India’
Startup Incubation and Innovation Centre, IIT Kanpur conducted a brainstorming session- ‘Medical Device Pathway in India’ along with two renowned dignitaries – Ms. Meena Dalal (Founder & CEO, TrialGuna) and Mr. M.H.Keerthi Chandra (Principal Consultant) on 5th August 2022.
The session touched upon the new Medical Device Rules (MDR) 2017 by CDSCO for budding MedTech entrepreneurs across the country to execute the timely marketing strategy of their Medtech innovations.
Manufacturing and monitoring of medical devices is a highly regulated practice. However, there were no specific medical device regulations in India, and devices were regulated under the Drugs and Cosmetics Act 1940. Understanding the new Medical Device Rules (MDR) 2017 by CDSCO, which is sensitive and time-bound, is essential for budding MedTech entrepreneurs, enabling them to ensure product and manufacturing compliance for their innovation in the Medtech domain.
Key takeaways from the session:
• Pre-Clinical & Clinical Research
• Medical Device trails
• Guidelines and Regulations for Medical Devices
• Clinical Trial registration
• Role of a CRO
• Case Study & FAQ
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