2026 (1) TMI 864 - AAR - Customs

Implanted annuloplasty band classification: artificial body part vs implanted support appliance under Tariff Heading 9021; ruled 9021 90 90

Dominant issue - classification under Tariff Heading 9021: the AAR examined whether the implanted annuloplasty band/ring constitutes an artificial part of ... Classification of goods - 'Annuloplasty Band/Ring' is classifiable under CTI 9021 39 00 (other artificial parts of the body) or under CTI 9021 90 90 (other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability) - Specificity principle (GRI 3(a)) - Seeking advance ruling - Explanatory Notes (WCO) - HELD THAT:- On examination of the product under consideration viz. 'Annuloplasty Bands/Ring', observe that the product under consideration is intended to replicate the natural movement and flexibility of the heart valve annulus, remaining permanently implanted to facilitate proper valve function by supporting effective opening and closure. The annuloplasty ring is surgically implanted around the valve annulus to reinforce and reshape it, enabling effective valve function. It does not replicate or substitute the anatomical structure of the valve but instead providing structural support and reinforcement to the existing valve annulus by facilitating optimal valve repair. 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 advantages of annuloplasty is preserving the native valve with lower risk of anticoagulation and the product under consideration are devices used in heart valve repair surgery to restore the normal size and shape of a valve annulus (the fibrous ring supporting a heart valve), most commonly for the mitral and tricuspid valves. I find, therefore, that the goods 'Annuloplasty Bands/Ring', is not a prosthetic substitute replacing a heart valve but a therapeutic implant providing structural support and reinforcement to the existing valve annulus by facilitating optimal valve repair while the native heart valve continues to exist around it which fails the anatomical replacement test under CTI 9021 31 00 and 9021 39 00. Therefore, the goods 'Annuloplasty Bands/Ring', is not a prosthetic substitute replacing a heart valve but a therapeutic implant providing structural support and reinforcement to the existing valve annulus by facilitating optimal valve repair while the native heart valve 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 'Annuloplasty Bands/Ring' neither replaces nor substitutes the geometry or structure of a body organ or segment but rather therapeutically structural support and reinforcement to the existing valve annulus. The product satisfies the legal scope of CTI 9021 90 90 as it is implanted in the body and providing only the structural support and reinforcement to the existing valve annulus 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 product under consideration. 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 Solitaire AB Stent 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. 'Annuloplasty Bands/Ring', proposed to be imported by the Applicant, merits classification under Tariff Heading 9021 and specifically under CTI 9021 90 90. Issues: Whether the product described as 'Annuloplasty Band/Ring' is classifiable under CTI 9021 39 00 (other artificial parts of the body) or under CTI 9021 90 90 (other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability).Analysis: The Authority examined the product description and its medical function, the terms of Heading 9021 and the competing subheadings, and the relevant Explanatory Notes and General Rules of Interpretation (GRI). The product is an implantable, biocompatible ring/band sutured to the heart annulus to provide structural support and to restore annular geometry, while the native valve and annulus remain in situ. The scope of subheading 9021.39 (other artificial parts of the body) in the Explanatory Notes contemplates items that wholly or partially replace defective anatomical parts and usually resemble them in appearance; examples include artificial limbs, heart valves and tubes for replacing blood vessels. Subheading 9021.90 is a residual entry covering other appliances implanted or worn to compensate for a defect or disability, including standalone assistive implants and parts/accessories of 9021 devices. The Authority found that the annuloplasty band does not replace or substitute the anatomical structure of the valve or annulus and does not satisfy the replacement/ resemblance characteristics central to 9021.39. Applying GRI 1 and GRI 6, and by elimination from preceding specific subheadings under Heading 9021, the product fits within the residual scope of 9021.90. Foreign CBP rulings cited by the applicant were noted but held not persuasive to override the tariff language and the classificatory criteria under the Indian schedule.Conclusion: The Annuloplasty Band/Ring is classifiable under CTI 9021 90 90 and not under CTI 9021 39 00. The ruling is therefore against the applicant's proposed classification.