India: Device Sponsors Need Data Showing Safety, Effectiveness

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 says. Conditional approvals may be given for devices with very high risk if the sponsor agrees to submit postmarketing study data on 10 percent to 25 percent of total sales for two years.
Clinical Trials Advisor