February 12, 2020 12:55:46 am
THE UNION Health Ministry has notified that medical equipment would qualify as “drugs” under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. Medical equipments under this definition include implantable medical devices such as knee implants, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine etc. This, the ministry hopes, will ensure these equipments follow quality standards.
The move comes in the wake of years of controversy about faulty hip implants of J&J.
“In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the April 1, 2020,” the notification read. The manufacture, import and sale of all medical devices will now need to be certified by the Central Drugs Standard Control Organisation.
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