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