Govt brings 8 new medical devices under regulatory framework

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In an endeavour to regulate quality of commonly used devices which play a crucial role in healthcare delivery, the Health Ministry has decided to bring eight new high-end medical devices including X-ray machines, MRI and CT scan equipment, and dialysis machines under the purview of Drugs and Cosmetics Act.

The Union Ministry of Health and Family Welfare has notified these devices as ‘drugs’ with effect from April 1, 2020. The list also includes defibrillators, PET equipment, and bone marrow cell separator.
“In pursuant of sub-clause (IV) of clause (b) of section 3 of the Drugs and Cosmetics Act of 1940, the central government after consultation with the drugs technical advisory board hereby specifies the following devices intended for use in human beings as drugs with effect from the first day of April 2020 namely — all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator,” a notification issued on Friday by the Health Ministry stated.

Currently, only 23 medical devices are regulated under the Drugs and Cosmetics Act. For all other medical devices, the Government has no mechanism to regulate their quality or efficacy. This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.

Nowonwards, it will be mandatory for manufacturers and importers to register all such products in the country and carry the details on their labels.

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