How does CDSCO handle the approval process for innovative medical devices?

The Central Drugs Standard Control Organisation (CDSCO)medical device handles the approval process for innovative medical devices through a rigorous evaluation involving safety, efficacy, and quality checks. This includes preclinical and clinical data review, regulatory submissions, and risk assessments. Applicants must submit comprehensive documentation, including clinical trial results and manufacturing details. CDSCO may consult expert committees for technical advice and typically grants approvals based on stringent guidelines, ensuring the medical devices meet national and international standards.