CDSCO proposes to include certain medical devices under definition of drug.

Jun 28, 2018 | by Avantis RegTech Legal Research Team


Central Drugs Standard Control Organization (CDSCO) vide notice dated June 22, 2018 has issued public notice for comments regarding inclusion of certain medical devices under definition of drug as specified in Drugs and Cosmetics Act, 1940.

Following devices have been proposed to be included-

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 will be notified in the official Gazette of India and it will come into force after a period of twelve months from the date of its publication. All the stakeholders are requested to forward their comments/suggestions within 21 days of issue of this notice prior to finalization of the notification, through email at [email protected] and [email protected] or in hard copies to the O/o DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002.

[F No. 18-13/2018-DC (Part-1)]

 

URL: http://cdsco.nic.in/writereaddata/2018_06_22_Public%20notice%20for%20commen.pdf


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