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 market, allowing for multiple importers for the same product, adding new products to an existing registration certificate and making labeling changes