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.

Devices may qualify for expedited review if they: (1) address unmet medical needs with no adequate treatment options; (2) demonstrate significant clinical advantages over existing treatments; (3) represent breakthrough technology or innovation; or (4) treat serious or life-threatening conditions. Applications for expedited review should be submitted through the SUGAM portal (sugam.cdsco.gov.in) and must include: (1) a written request for expedited review with detailed justification; (2) comprehensive technical dossier and device specifications; (3) clinical evidence demonstrating unmet need or clinical benefit; (4) comparative analysis with existing treatments where available; (5) manufacturing and quality information; (6) safety and performance data from preclinical or clinical studies. Expedited review typically results in a 30–60 day review timeline compared to standard 60–90 day timelines, though actual duration depends on submission completeness and CDSCO workload.