Research Use Only

Official source: CDSCO; AYUSH Ministry

Research Use Only (RUO) designation may apply to medical devices used exclusively in clinical research or investigational settings, not for commercial patient care. Devices intended for clinical investigations must obtain Clinical Investigation Permission from CDSCO. The application must include a detailed research protocol, institutional ethics committee approval, investigator qualifications, and evidence of device safety. Research use does not constitute market approval and devices cannot be sold or marketed to patients outside the approved investigation.

For devices intended for clinical research, applicants must obtain Clinical Investigation Permission from CDSCO before commencing any human studies. The application should be submitted through the SUGAM portal (sugam.cdsco.gov.in) and must include: (1) detailed research protocol describing objectives, study design, patient population, and endpoints; (2) institutional ethics committee (IEC) approval; (3) investigator qualifications and experience; (4) device specifications and manufacturing information; (5) non-clinical and clinical safety and performance data; (6) risk assessment and mitigation strategies; (7) informed consent form (ICF); (8) insurance/compensation plan details. Clinical Investigation Permission typically applies to human subjects trials and is distinct from RUO, which may apply to non-human or exploratory laboratory use. Approval timelines are typically 30–60 days from submission.