Source: THE HINDU-14th February,2020
Decision aimed at ensuring that all medical devices meet certain standards of quality and efficacy
The Union Health Ministry notified medical devices used on humans as
drugs under the Drugs and Cosmetics Act with effect from April 1, and released
the Medical Devices Amendment Rules, 2020, for mandatory registration of such
devices. The notification will make companies accountable for quality, said an
official. However, Rajiv Nath, Coordinator of Association of Indian Medical
Device Industry, said small manufacturers making low-risk equipment would find
it tough to comply with the new rules.
