Defining Devices in India: Country Takes Next Step With its Budding Device Rules

ARTICLE SUMMARY:

India has historically handled medical devices as an afterthought within its pharmaceutical regulatory system. But the country has taken steps in recent years to adopt a framework that is more customized for devices. Last month, it proposed to apply that framework more broadly.

India’s drug regulators are slowly but surely recognizing that devices are different. The country’s laws define medical devices as drugs, and, over the years, the government has conscripted, or “notified,” select devices to undergo the same regulatory requirements as a new pharmaceutical would.

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