Expedited Review

Official source: CDSCO; AYUSH Ministry

Expedited review (sometimes called Priority Review) may be available for medical devices that address unmet medical needs or offer significant clinical advantages over existing treatments. Under this pathway, CDSCO may process applications with compressed timelines. To qualify, devices typically must demonstrate innovation, clinical benefit, or address conditions with no adequate treatment options. Applications require comprehensive technical dossiers, clinical evidence, and supporting documentation. Contact CDSCO through the SUGAM portal for eligibility assessment.