NPPA informs that the Medical Devices use in human beings or animals as drugs will be governed as per Drug (Price Control) Order, 2013

Apr 03, 2020 | by Avantis RegTech Legal Research Team


Industry Specific Compliance

The National Pharmaceutical Pricing Authority (NPPA) on March 31, 2020, informs that the Medical Devices use in human beings or animals as drugs will be governed as per Drug (Price Control) Order, 2013.

Vide Notification No. S.O. 648(E) dated February 11, 2020, Ministry of Health and Family Welfare (MoHFW) specifies the following devices intended for use in human beings or animals as drugs with effect from April 01, 2020:

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means.

However, this Notification clarifies that the above-mentioned Medical Devices will be governed under the provisions of the Drug (Price Control) Order, 2013.

[Order No. S.O. 1232(E)]


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