2026 (1) TMI 59 - AAR - Customs

Imported embolization coil classification: 'artificial body part' vs implanted therapeutic appliance; placed under CTI 9021 90 90.

The dominant issue was classification of an imported embolization coil under Heading 9021, i.e., as an 'artificial part of the body' (CTI 9021 39 00) or ... Classification of imported embolization coil - classifiable as an other artificial part of the body under tariff item 9021 39 00, or as an other appliance, implanted in the body, to compensate for a defect or disability under tariff item 9021 90 90? - HELD THAT:- The product satisfies the legal scope of CTI 9021 90 90 as it is implanted in the body and compensates a medical defect (aneurysm/vascular malformation/blood- flow leakage risk) but it does not replace anatomy and the same is not covered by preceding single- dash entries CTI 9021 10 to 39. Although the Harmonized System is aligned globally at the six-digit level, the Indian tariff at the eight-digit CTI level, along with the accompanying legal notes and interpretative principles, diverges in material respects. Moreover, none of the cited rulings pertain to devices whose therapeutic effect is achieved by inducing a controlled occlusion within an existing native vessel, as is the case with the Embolization coil. In view of above, the functional analogy sought to be drawn cannot override the explicit tariff language or the primary classificatory criterion under Heading 9021, which is the replacement or anatomical substitution of a defective body part, a condition not satisfied in the present matter. Accordingly, while the foreign rulings have been duly noted, they do not hold persuasive value for classifying the Embolization coil as an artificial part of the body under Indian CTI 9021 39 00. The goods viz. 'Embolization coil', proposed to be imported by the Applicant, merits classification under Tariff Heading 9021 and specifically under CTI 9021 90 90. Issues: Whether the product 'Embolization coil' is classifiable under CTI 9021 39 00 (Other artificial parts of the body) or under CTI 9021 90 90 (Other) for the purposes of the Customs Tariff.Analysis: The Authority applied the General Rules of Interpretation (GRI) of the Harmonized System, relevant Chapter and Explanatory Notes to Heading 9021 and the information on record about the product's nature, composition, mode of deployment and therapeutic effect. Under GRI 1 the goods are prima facie classifiable in Heading 9021. GRI 6 requires comparison of competing subheadings at the same hierarchical level. The Explanatory Notes to Heading 9021 distinguish between artificial parts that 'wholly or partially replace defective parts of the body' (examples: limbs, joints, tubes replacing blood vessels, heart valves) and other implanted or wearable appliances that compensate for a defect without replacing anatomy (examples: pacemakers, insulin pumps). The applicant contended that embolization coils are implantable prosthetic devices akin to vascular grafts or stents and therefore fall within 9021 39 00, relying on GRI 3(a) and GRI 4 and foreign CBP rulings. The jurisdictional Commissionerate and the Authority examined the device's functional effect and concluded that the coil is implanted into an existing native vessel to induce occlusion (thrombosis) rather than to replace, restore or substitute the anatomical structure. The coil does not replicate or substitute the geometry of the vessel wall but creates an intentional flow-terminating occlusion within an existing vessel. Because it does not perform anatomical replacement or structural substitution as contemplated by the Explanatory Notes for 'artificial parts of the body', it fails the definitional test for CTI 9021 39 00. As the device does not fall within specific preceding single-dash entries (9021 10 to 9021 50) and meets the descriptive scope of 'Other' appliances implanted to compensate for a defect or disability under Heading 9021, classification by elimination under GRI 6 supports placement in CTI 9021 90 90. Foreign rulings cited by the applicant were noted but found not persuasive to override the tariff language and Explanatory Notes as applied to the facts of this product in the Indian tariff context.Conclusion: The Embolization coil is classifiable under CTI 9021 90 90 (Other).