In re India Medtronic Private Limited (CAAR Delhi)
The application before the Customs Authority for Advance Rulings (CAAR), New Delhi, was filed seeking an advance ruling on the appropriate customs tariff classification of the product known as the “Onyx Embolization Liquid System.” The application was made under Section 28H(2) of the Customs Act, 1962, read with the CAAR Regulations, 2021. The applicant is engaged in the import and distribution of medical devices used in neurovascular and peripheral vascular procedures.
The product under consideration is a non-adhesive liquid embolic agent used for embolization of abnormal blood vessels. It is composed of ethylene vinyl alcohol (EVOH) copolymer, dimethyl sulfoxide (DMSO), and micronized tantalum powder. The product is injected through a microcatheter under fluoroscopic guidance. Upon contact with blood, the DMSO diffuses away and the EVOH copolymer precipitates to form a spongy polymer cast, which occludes abnormal vascular channels. The tantalum powder provides radiopacity for visualization during the procedure.
The product is used for embolization in conditions such as cerebral arteriovenous malformations (AVMs), dural arteriovenous fistulas (DAVFs), hypervascular tumors, aneurysms, vascular hemorrhages, and other abnormal vascular malformations. Once deployed, the product remains permanently within the vascular system and functions by blocking blood flow to the targeted abnormal vessels. It does not replace any anatomical structure but occludes vessels from within.
