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.
Source: CDSCO
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