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India Takes Another Stab At Regulating Devices As Devices

 
• By Vibha Sharma

As part of the Indian government's three-pronged strategy to bring the entire medtech sector under regulatory control, it has proposed new rules and finalized quality management system standards for medical devices and in vitro diagnostics.

Indian government building

The Indian government is inviting stakeholder feedback on new draft rules that aim to introduce a risk-based approach to support the regulation of certain medical devices that are currently being regulated as drugs.

The proposed Medical Device Rules, 2016, represent an interim arrangement and will only apply to the...

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