NEW DELHI: To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry on Tuesday notified medical equipment used on humans or animals as “drugs” under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020.
Medical equipment include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.
The aim is to regulate all medical devices so that they meet certain standards of quality. Besides it will also make medical device companies accountable for quality and safety of their products, a senior official said. (AGENCIES)
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