Home » India: Clinical Trial Data Needed To Show Device Safety, Efficacy
India: Clinical Trial Data Needed To Show Device Safety, Efficacy
October 12, 2010
Devicemakers seeking marketing approval in India for products 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.
To View This Article:
Subscribe To International Medical Device Regulatory Monitor