All implantable medical devices, CT scan / MRI equipment’s / X-ray machines / Dialysis machines likely to be included as ‘Drugs’

In a Public Notice dated 22nd June, 2018, the Central Drugs Standard Control Organization (“CDSCO”) has invited comments on a proposal to include all implantable medical devices and other high-end equipment as ‘Drugs’ under the Drugs and Cosmetics Act, 1940.

The following medical devices are sought to be included as drugs –

1) All implantable Medical Devices

2) CT scan equipment

3) MRI equipment

4) Defibrillators

5) Dialysis machine

6) PET equipment

7) X-Ray machine

8) Bone marrow cell separator

This notice will be published in the Official Gazette and will come into force after a period of twelve months from the date of such publication.

Stakeholders have been requested to forward their comments/ suggestions by 13th July, 2018 addressing an e-mail to  dci@nic.in and dccdtab@cdsco.nic.in or in hard copies to the O/o DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002.

SourceCDSCO

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