Eight medical Equipment as Drugs by the Health Ministry

The government has notified the following eight medical equipments as Drugs after consultation with the Drugs Technical Advisory Board:

  • All implantable devices.
  • CT scan.
  • PET equipment.
  • MRI equipment.
  • Defibrillators.
  • Dialysis machines.
  • Bone marrow separators.
  • X-ray machine.

The notification has been made under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. The notification brings all the implantable and diagnostic devices will come under the regulatory framework. This is a big step forward as the majority of the medical devices were unregulated in India.

Drugs Technical Advisory Board (DTAB)

DTAB is the highest statutory decision-making body on technical matters related to drugs in India. It was constituted under the provisions of the Drugs and Cosmetics Act, 1940. DTAB is part of the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

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