EU-Approved Medical Devices to Reach India Faster
What Happened
The government has amended the Medical Devices Rules, 2017 to simplify regulations and speed up access to advanced medical technologies. A key change is the inclusion of the European Union in the list of recognised regulatory jurisdictions, allowing eligible EU-approved medical devices to qualify for waivers from certain clinical investigation requirements in India.
Key Takeaways
Less paperwork, faster approvals, and quicker entry for EU-approved medical devices could improve access to cutting-edge healthcare technology in India.