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Home » India: Device Sponsors Need Data Showing Safety, Effectiveness
India: Device Sponsors Need Data Showing Safety, Effectiveness
September 29, 2010
Sponsors seeking marketing approval in India for medical devices with moderate-to-high risk must have data from well-randomized, statistically significant Phase II and III pivotal studies showing the product is safe and effective, a draft guideline from the Central Drugs Standard Control Organization (CDSCO) says.