India’s MedTech Revolution: What’s Holding It Back & What’s Pushing It Forward?

India's MedTech sector is transforming with a paradigm shift, with the Medical Device Rules (MDR), 2017, and government initiatives like the Materiovigilance Programme of India (MvPI) fueling this transformation. With market growth estimated at 15% annually, compliance with international standards has its prospects as well as pitfalls.

Key Challenges:

• Excessive Compliance Costs: The small companies face financial issues due to expensive certification, testing, and post-market surveillance.

•⁠  ⁠Regulatory complexity: excessive amendments and non-coordination with global standards such as FDA or CE Mark hinder product launches.

•⁠  ⁠Lack of skilled talent: reduced expertise in the manufacturing and regulatory affairs sector is an inhibitor of innovation

Opportunities

•⁠  ⁠Government initiatives like Make in India and strategic plan of ₹500 crores are encouraging indigenous production and innovation

•⁠  ⁠Digitalization, AI-based diagnostics, and tie-ups with international players are stepping stones for India to emerge as a new MedTech hub.

India's evolving regulatory landscape is full of huge potential but requires effective processes and robust infrastructure.

Source: RegDesk, EY, Nishith Desai Associates