A parliamentary standing committee responsible for health and technology issues has urged the Government of India to modernise and digitise medical device approval processes to better support innovation, reduce regulatory lag and strengthen the country’s medtech sector.

In its latest recommendations, the committee highlighted that lengthy manual approval systems  including paperwork-intensive submissions and fragmented compliance pathways are slowing down the entry of new medical devices into the Indian market. Such delays, the panel noted, stifle innovation, elevate costs, and diminish the competitiveness of domestic manufacturers who seek to scale both locally and internationally.

To address these challenges, the panel recommended that regulators adopt automated, digitised approval systems with integrated data portals, risk-based categorisation frameworks and seamless tracking mechanisms. By shifting toward digital workflows  including e-submissions, online review dashboards and centralised databases  the panel argued that regulators can significantly reduce processing times while maintaining safety and quality standards.

Members of the committee also urged the adoption of real-time data analytics and interoperability standards, which would allow regulators to assess safety and performance more efficiently. The panel’s report emphasised that robust digital systems could make the regulatory environment more transparent, predictable and innovation-friendly  crucial factors for start-ups, SMEs and multinational medtech firms alike.

In conclusion, the committee maintained that a forward-looking, digitised regulatory framework is essential to align India’s medical device ecosystem with global best practices, encourage research and development, and support the country’s healthcare ambitions under programs such as Make in India and Aatmanirbhar Bharat.