India Slashes Medical Device Approval Timelines by Up to 25 Days
The Union health ministry has proposed amendments to the Medical Devices Rules, 2017, to reduce the time taken for granting manufacturing licences for certain medical devices. The draft notification, now open for public comments, aims to streamline the regulatory process without compromising quality, safety, and performance standards.
Under the proposed changes, the approval timeline for Class B medical devices—such as blood pressure monitors, pulse oximeters, and hypodermic needles—would be shortened from 140 days to 115 days, a reduction of 25 days. For Class C and Class D devices, including cardiac stents, hip and knee implants, and other orthopaedic implants, the timeline would be cut from 105 days to 90 days, a saving of 15 days.
The amendments also prescribe fixed timelines for each stage of regulatory scrutiny, aiming to bring predictability and efficiency to the licensing process. This move is expected to benefit manufacturers and, ultimately, patients by ensuring faster access to essential medical devices.
The health ministry has placed the draft notification in the public domain and invited feedback from stakeholders within a specified period. The proposed changes are part of broader efforts to improve the ease of doing business in the medical device sector while maintaining rigorous standards.
