Medical device makers set for quicker clearances

NEW DELHI: Manufacturers of blood pressure monitors, cardiac stents, hip and knee implants and other medical devices could soon get regulatory approvals up to 25 days faster, with the Centre proposing changes to streamline the licensing process while retaining existing quality, safety and performance standards. Union health ministry has issued draft amendments to Medical Devices Rules, 2017, proposing to shorten manufacturing licence approval timelines and prescribe fixed timelines for every stage of regulatory scrutiny. The draft notification has been placed in public domain for stakeholder comments. Under the proposal, time taken to grant manufacturing licences for Class B medical devices, including blood pressure monitors, pulse oximeters and hypodermic needles, would be reduced from 140 days to 115 days. For Class C and Class D medical devices, including cardiac stents, hip and knee implants and other orthopaedic implants, the approval timeline would be cut from 105 days to 90 days.