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.