India has amended its Medical Devices Rules 2017 to ease regulatory requirements for their medical device sector. Rule 63 now recognizes European Union approvals as sufficient grounds to waive clinical trial requirements in India, adding the EU to a list that already includes the US, UK, Australia, Canada, and Japan. Rule 44 removes the requirement for a separate sterilization license for manufacturers who outsource sterilization to third-party facilities rather than maintaining an in-house capability.
The changes affect a broad range of imported devices, including electronic and imaging equipment such as MRI scanners, CT scan systems, and PET scanners, cardiac devices including pacemakers and implantable cardioverter-defibrillators, and orthopedic implants used in joint replacement and spinal surgery. The amendments align with global regulatory standards, as the government expects the rule changes to reduce redundant testing costs, shorten the time to market for new technologies, and lower device prices for the domestic market. The amendment extends a pathway that manufacturers from the US, UK, Australia, Canada, and Japan already use to enter the Indian market without repeating clinical trials completed under their home jurisdictions’ regulatory review.