Ayush Borderline

Official source: CDSCO; AYUSH Ministry

Ayush Borderline devices are traditional medicine and systems of medicine devices that fall outside conventional allopathic medical device classification. Devices classified as Ayush Borderline are regulated under both the Medical Devices Rules 2017 and relevant AYUSH Ministry guidelines. These may include devices used in Ayurveda, Siddha, Unani, and Homeopathy systems. Manufacturers should consult with both CDSCO and the relevant AYUSH Ministry department to determine licensing and notification requirements applicable to their specific device.