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Regulator Answers Industry's Questions About India’s New Medical Device Rules

 
• By Vibha Sharma

A new FAQ document from India's health-care products regulator clarifies requirements relating to manufacturing licenses and other issues under the new medical device rules that came into effect on Jan. 1.

Compliance

India's Central Drugs Standard Control Organization (CDSCO) has issued a document to address the frequent questions that the medtech industry has raised in response to the Medical Device Rules that came into effect in January.

The FAQ document clarifies a variety of issues, including inspection timelines, how to apply for and renew manufacturing licenses, the submission of clinical data for devices already on the...

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