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of <h1>Onyx vascular occlusion device classification as anatomical replacement versus implanted appliance; found not anatomical replacement, classifiable under 9021 90 90</h1> Whether the device is classifiable as an artificial part of the body under CTI 9021 31/39 or as another implanted appliance under CTI 9021 90 90: applying ... Classification of goods - 'Onyx Embolization System' classifiable under subheading 9021 39 00 (other artificial parts of the body) Or under subheading 9021 90 90 (other appliances implanted in the body to compensate for a defect or disability) - General Rules for the Interpretation (GRI) of the Harmonized System - Essential character / most specific description - Explanatory Notes to Heading 9021 - Customs Authority for Advance Rulings - HELD THAT:- It is a well-settled principle of law that the classification of goods under the Customs Tariff Act, 1975 is governed by the General Rules for the Interpretation of the Import Tariff (GRI). Rule I of the GRI mandates that 'classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes'. Only where the terms of the headings or the relevant notes do not determine the classification, does recourse lie to the subsequent rules. The Explanatory Notes to Heading 9021 further clarifies that the scope of the heading is restricted to appliances which wholly or partially replace defective parts of the body or compensate for a defect or disability. In particular, the Notes specify that 'artificial parts of the body' include items such as artificial limbs, joints, ocular fittings, dental fittings and similar devices that replicate or substitute natural anatomical structures, usually resembling them in form or function. They further elaborate that this heading also covers certain implantable appliances designed to compensate for physiological deficiencies, such as pacemakers, speech aids for persons without vocal cords, and electronic aids for the blind. On examination of the product under consideration viz. 'Onyx Embolization system', I observe that the fundamental purpose of the Onyx system is to occlude and block abnormal blood vessels by stopping blood flow from within the vascular structure. This is different from replacing or restoring normal anatomical structure of the vessels. The system blocks an existing abnormal vessel rather than substituting for a missing or removed structure implanted within an existing blood vessel. Its function is therefore therapeutic rather than structural replacement. The device is a self-contained implantable medical appliance and is not intended to act as an artificial part of the body in the sense contemplated under CTI 9021 31 00 or 9021 39 00. The instant Onyx system does the conceptual opposite, it intentionally occupies the vascular defect cavity to induce thrombosis and terminate flow without substituting any anatomical segment. Therefore, the goods 'Onyx system', is not a prosthetic substitute replacing a blood vessel or aneurysm wall segment but a therapeutic implant causing deliberate intravascular occlusion while the native blood vessel continues to exist around it, which fails the anatomical replacement test under CTI 9021 31 00 and 9021 39 00. Accordingly, reject the applicant's claim for classification under 9021 39 00, on the basis that the Onyx embolization system neither replaces nor substitutes the geometry or structure of a body organ or segment but rather therapeutically occludes a vascular defect cavity without anatomical substitution. The goods viz. 'Onyx embolization system', is covered under the umbrella of Heading 9021 at the four-digit level, being a device implanted to compensate a defect. This is not contested. For selecting the correct single-dash and eight-digit classification, I observe that competing entries must be at the same hierarchical level. I find that, by elimination, CTI 9021 3100 and CTI 9021 39 00, are not applicable. Now, I examine the scope under 9021 90 90. 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 Onyx embolization system as an artificial part of the body under Indian CTI 9021 39 00. In view of the foregoing analysis, I am of the considered view that the goods viz. 'Onyx embolization system', proposed to be imported by the Applicant, merits classification under Tariff Heading 9021 and specifically under CTI 9021 90 90. Issues: Whether the product 'Onyx Embolization System' is classifiable under subheading 9021 39 00 (other artificial parts of the body) or under subheading 9021 90 90 (other appliances implanted in the body to compensate for a defect or disability).Analysis: The applicable legal framework comprises the General Rules of Interpretation (GRI) including Rule 1, Rule 6, Rule 3(a) and, where applicable, Rule 4, together with the Explanatory Notes to Heading 9021 of the First Schedule to the Customs Tariff Act, 1975 and the provisions of Section 28H(1) of the Customs Act, 1962 and CAAR Regulations, 2021. Heading 9021 covers artificial parts of the body and other appliances implanted or worn to compensate for defects. The Explanatory Notes identify 'artificial parts of the body' as items that wholly or partially replace defective body parts and usually resemble them in appearance (examples: artificial limbs, tubes replacing blood vessels, heart valves). Applying GRI 1 and then GRI 6, the subheadings must be interpreted by their terms. The decisive factual-legal criterion is whether the good replaces/substitutes anatomical structure (qualifying for 9021.39) or instead is an implanted appliance that compensates without replacing anatomy (falling under the residual 9021.90). On the facts, the Onyx system is injected into existing abnormal vessels to create a controlled occlusion by forming a polymer cast; it does not replace, restore, or substitute an absent anatomical segment nor does it resemble a body part in the sense required by the Explanatory Notes. The device's therapeutic mechanism is permanent occlusion of an existing vessel rather than anatomical substitution. Foreign CBP rulings cited are noted but do not override the tariff language and Explanatory Notes as applied to the Indian CTI structure.Conclusion: The product is classifiable under CTI 9021 90 90. This conclusion is against the applicant and in favour of the Revenue.
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