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Home » India Proposal Would Set Distinct Standards for Medical Devices
India Proposal Would Set Distinct Standards for Medical Devices
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The Drugs Controller General of India proposed rules that would for the first time set separate standards for devices.
The Indian regulator announced in July that it would abandon a proposed law that would have amended parts of India’s Drugs and Cosmetic Act of 1940, and instead develop a separate device regulation.
In the draft document, the regulator proposed third-party certification bodies, similar to those in the EU, as well as a four-tiered risk-based classification system for devices. — Tamra Sami
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