Govt brings 8 new medical devices under regulatory framework
Aiming to regulate the quality of commonly used medical devices in the Indian healthcare system, Ministry of Health and Family Welfare (MOHFW) has released a notification bringing 8 medical devices under the regulatory regime.

The 8 medical devices shall be referred to as 'drugs' with effect from April 1, 2020 under the pursuance of the Drugs and Cosmetics Act, 1940 (23 of 1940).

The notification enlists the following medical devices intended for use in human beings as drugs:

- All implantable medical devices
- CT Scan Equipment
- MRI Equipment
- Defibrillators
- Dialysis Machine
- PET Equipment
- X-Ray Machine
- Bone marrow cell separator

The notification comes after a committee meeting headed by Drugs Controller General of India (DGCI); attended by representatives from medical devices companies.

In a separate meeting constituted by Ministry of Health, it was decided to bring all such devices under regulatory scanner by making it mandatory for manufacturers to register devices in the country and report adverse events caused by such devices to human.

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