Industry Odisha Bureau, Jun 29: Basing on the suggestions reportedly made by the Drugs and Technical Advisory Board (DTAB) that had also reportedly held detailed consultations, and also with an aim to fast-track licensing approvals reportedly for moderate-to-high-risk medical devices ensuring safety and quality, the Union Ministry of Health and Family Welfare (MoHFW) has reportedly proposed amendments to the Medical Devices Rules-2017.
As reported, the MoHFW statement read: “A draft notification is being published in the Official Gazette proposing amendments to the Medical Devices Rules, 2017, with the objective of simplifying and expediting the licensing process for medical devices while ensuring continued compliance with quality, safety and performance requirements,”
The Medical Devices Rules-2017 reportedly “classify medical devices into four risk-based categories, such as Class A, Class B, Class C and Class D, while Class D comprises the highest-risk devices.”
Further, it has been reported that, “The Medical Devices Rules-2017 prescribes statutory timelines for processing manufacturers’ applications for the grant of manufacturing licences in each category”, and thus, the proposed amendments in the Rules “seek to reduce the timelines”.
Reportedly, “there has been no change in the timeline for Class A medical devices that include low-risk items like medical thermometers and stethoscopes, etc.”
“The timeline for grant of a manufacturing licence has been proposed to be reduced from 140 days to 115 days for the Class B medical devices that include low- to- moderate-risk devices, like the blood pressure monitors, hypodermic needles and pulse oximeters.”
“The timeline for granting a manufacturing licence has been proposed to be reduced from 105 days to 90 days for the Class C and Class D medical devices, that include high-risk devices, like cardiac stents, hip and knee implants, and other orthopaedic implants.”
