3D Printed Medical Equipment - Legality

Hi all,

I need some help figuring out the legality of 3D printed medical equipment in India. Is there any existing legal framework in India that covers this?

I found open source design files for building 3D printer face shields so was just wondering. I know this is generally more expensive to produce but good for urgent use where mainstream manufacturing cannot deliver quickly. Not saying there is anything we can do now but might help in future.


Pardon me. I couldn’t find a relevant discussion category for this. :frowning_face:

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Hi Bhavyanshu!

The Drugs and Cosmetics Act 1940 (“D&C Act”) along with the Drugs & Cosmetics Rules 1945 (“D&C Rules”) and the Medical Device Rules 2017 (“MDR”) is the primary legislative framework regulating drugs and medical devices in India. Currently, only certain medical devices that have been notified by the MoHFW are regulated as ‘notified medical devices’ under the ambit of the D&C Act and the MDR. Therefore, under the current legal framework 3D medical devices are not prohibited provided provided the manufacturer possesses the requisite approvals from the regulator for manufacture of the drug or medical device.

You can refer to the link attached for a detailed understanding. Hope this helped!(http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/3D_Printing.pdf )

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