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. These devices are used in Ayurveda, Siddha, Unani, and Homeopathy systems. Devices classified as AYUSH Borderline are regulated under both the Medical Devices Rules 2017 and relevant Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy) guidelines. Regulatory jurisdiction and approval authority depend on the specific device and system. Manufacturers must determine whether their device falls under CDSCO jurisdiction, AYUSH Ministry jurisdiction, or joint jurisdiction before applying. Licensing and notification requirements vary by classification. Manufacturers should consult with both CDSCO and the relevant AYUSH Ministry department (typically the Central Council for Research in Ayurvedic Sciences, Central Council for Research in Unani Medicine, Central Council for Research in Siddha, or Central Council for Research in Homeopathy) to determine the correct regulatory pathway for their specific device.