TaxTMI 
TaxTMI 
TaxTMI 
2026 (1) TMI 23
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....t's submissions are as given below :- 1.2. M/s India Medtronic Private Limited having office at 4th Floor, SAS Tower, Sector 38, Medanta Hospital, Gurugram, Haryana-122001, holding IEC number 3496003171, are engaged in the trading and distribution of medical devices and technologies, providing solutions in areas such as heart care, surgery, brain and spine conditions, and diabetes management. 1.3. As part of its operations in India, the applicant imports Solitaire AB stent (hereinafter referred to as "the product", "the product under consideration", or "the product in question") for use in medical and surgical procedures. The Solitaire AB stent is a small tube made from nitinol (nickel- titanium alloy) that can expand on its own. It is used inside the brain's blood vessels (intracranial use) during a procedure called endovascular treatment to manage difficult or wide openings (wide-necked or complex cerebral aneurysms). The stent works like a support frame (scaffold) placed across the weak spot (aneurysm neck) so that tiny metal wires (Solitaire AB Stents) can stay securely inside the ballooned area (aneurysm sac). This device is placed inside the body (implantable de....
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....nt of wide-necked or complex cerebral aneurysms. Its role can be described as follows: ○ It acts as a scaffold within the parent vessel (the main blood vessel where the aneurysm forms). ○ It bridges the neck of the aneurysm, creating a barrier that secures Solitaire AB Stents inside the aneurysm sac. ○ It prevents coil migration into the parent vessel, ensuring uninterrupted blood flow. ○ It maintains vessel patency (keeps the parent vessel open for normal circulation). ○ It supports thrombosis within the aneurysm sac, effectively sealing it off from circulation. ○ It reduces the risk of aneurysm rupture or re-rupture, thereby preventing intracranial haemorrhage. 1.8. Material Composition ○ The stent is made of nitinol (nickel-titanium alloy), a highly flexible, biocompatible material known for its shape-memory and super elastic properties. This allows the stent to be compressed into a small delivery system and then self-expand precisely at the target site within the cerebral vasculature. ○ It also includes radiopaque markers (commonly platinum-iridium or tanta....
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....f the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability. 1.12. The Solitaire AB device is an implantable artificial part used to support vascular function by providing a stable scaffold during stent-assisted coiling. It is deployed across the neck of the aneurysm within the parent vessel, where it mechanically supports the secure placement of Solitaire AB Stents inside the aneurysm sac. This prevents coil migration, reduces the risk of aneurysm rupture caused by blood flow pressure, and helps avoid intracranial haemorrhage. Therefore, prima facie, the device appropriately falls within the scope of Heading 9021, with no ambiguity regarding its classification at the four-digit level. 1.13. However, it is understood from trade circles that divergent practices are currently being followed with respect to the classification of the product at the 6-digit level. Specifically, while certain importers are classifying the Solitaire AB stent under sub-heading 9021.39, which covers "other artificial parts of the body," others are classifying it under sub-heading 9021.90, a residual category covering "othe....
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....plantable devices may exhibit features and functionalities that conceptually align with both subheadings. 1.16. Considering the implantable nature of product and its critical role in maintaining the structural and functional integrity of the cerebral vasculature, a detailed analysis is required to determine the most appropriate classification between the two competing tariff entries. 1.17. In view of the possibility of the product answering to the scope of two competing subheadings, the applicant has conducted a preliminary assessment of the product's characteristics and medical application. Based on this assessment, the applicant is of the considered opinion that the "Solitaire AB stent" is more appropriately classifiable under subheading 9021.39, which pertains to implantable artificial parts of the body and better reflects the product's essential nature and function. The primary reason for the same is that the product is indisputably an artificial and implantable device designed to provide structural support within the cerebral vasculature during the treatment of intracranial aneurysms; and that being so, it gets covered under the subheading 9021.39. Since the comp....
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....offers the most specific description. Rule 3: When by application of rule 2(b) or for any other reason, goods are, prima facie, classifiable under two or more headings, classification shall be affected as follows: a) The heading which provides the most specific description shall be preferred to headings providing a more general description. However, when two or more headings each refer to part only of the materials or substances contained in mixed or composite goods or to part only of the items in a set put up for retail sale, those headings are to be regarded as equally specific in relation to those goods, even if one of them gives a more complete or precise description of the goods. 1.20.3. Rule 6 further clarifies that the classification of goods within subheadings must be determined by the terms of those subheadings and any related notes. This rule applies mutatis mutandis to the preceding rules, with the understanding that only subheadings at the same hierarchical level are comparable. Section, Chapter, and subchapter notes also apply unless the context dictates otherwise. b) Rule 6: "For legal purposes, the classification of goods in the subheadi....
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....Rule 1 of the Harmonized System of Nomenclature, classification must be based on the terms of the headings and any relevant Section or Chapter Notes. Heading 9021 of the Indian Customs Tariff explicitly covers artificial parts of the body and prosthetic implants, thereby providing a clear and direct basis for classification. Given the nature and intended function of the product under consideration, it squarely falls within the scope of Heading 9021, as it is designed to compensate for a structural or functional defect in the human body. 1.24. For ease of reference, the relevant extract of the Schedule 1 to the Customs Tariff Act, 1975 has been provided below: Tariff code Description of Goods Chapter 90 Optical, photographic, cinematographic, measuring checking, precision, medical or surgical instruments and apparatus, parts and accessories thereof 9021 Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability. 9021 10 00 - Orthopaedic or fracture a....
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....accessory intended solely or principally for use with a 9021 device, or a compensatory appliance of the type described in the Explanatory Notes. 1.28. Further, for ease of reference, a comparison table between HS subheadings 9021.39 and 9021.90, based on the above explanatory notes, is provided below: Aspect HS Code 9021.39 - Other Artificial Parts of the Body HS Code 9021.90 - Other Appliances and Parts/Accessories Description Covers artificial body parts not elsewhere specified. Includes implantable or external devices that structurally replace, support, or compensate defective anatomy. Residual subheading. Covers (i) parts and accessories of devices under 9021, and (ii) certain standalone compensatory appliances (mainly electronic aids). Function Devices that replace, support, or assume the role of a natural body part. Devices that help compensate for a defect or disability, or parts that enable/assist 9021 devices, but are not themselves artificial body parts. Standalone Use Yes, typically standalone prosthetic or implantable devices with independent therapeutic/anatomical function. Yes, may include standalone assistive appliances (e....
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....icial parts of the body, subheading 9021.90 functions as a residual category within Heading 9021. It applies to two main groups: (i) parts and accessories designed solely or principally for use with prosthetic and implantable devices of this heading, such as connectors, joints, or valves; and (ii) certain standalone therapeutic or assistive appliances, such as insulin pumps, speech aids, or electronic aids for the blind, which help compensate for a defect or disability but do not themselves replace anatomical structures. Consistent with tariff principles, this residual subheading should only be invoked when it is clearly established that the product cannot be classified more specifically under another provision of Heading 9021. 1.31. The Solitaire AB Stent is a permanent, implantable medical device used in the neuro endovascular treatment of wide-necked or complex intracranial aneurysms. Once delivered through a microcatheter, the stent acts as a self-expanding scaffold to prevent Solitaire AB Stent herniation into the parent artery and to ensure secure placement of coils within the aneurysm sac. This enables durable occlusion of the aneurysm and maintains vascular patency, ther....
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....fically covers "other artificial parts of the body" and best reflects the device's nature as a permanent implant that restores anatomical integrity of blood vessels. In contrast, sub-heading 9021.90 serves as a residual provision for parts, accessories, and certain therapeutic aids, and does not explicitly encompass such implantable devices. Accordingly, applying GRI 6 and the principle of specificity under GRI 3(a), classification under sub-heading 9021.39 is more appropriate and legally justified classification. 1.36. In this regard, reliance is also placed on U.S. Customs and Border Protection (CBP) Ruling No. N076947, which addresses the classification of various stents and stent grafts intended for permanent implantation to treat conditions such as coronary artery disease and aortic aneurysms. The CBP noted that these devices made from surgical-grade metals and biocompatible materials are intended to be implanted in the human body to restore or maintain normal physiological function by supporting or replacing damaged vascular structures. The ruling held that such devices fall under subheading 9021.39.0000, HTSUS, as "other artificial parts of the body," given their role....
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....erefore, HS Code 9021.39 is a more appropriate classification for the Solitaire AB stent. * Subheading 9021.90 further pertains to the residual entry under Heading 9021 and does not specifically describe the Solitaire AB stent, which is designed to remain permanently implanted within the vascular system as a structural support. Hence, it is not the most suitable classification. * In accordance with GRI 3(a), HS Code 9021.39, which explicitly covers "other artificial parts of the body," is more specific than the residual subheading 9021.90 and therefore takes precedence. * Therefore, by application of GRI 1, 3(a), and 6, the Solitaire AB stent is appropriately classifiable under HS Code 9021.39, which encompasses implantable devices that function as artificial body parts, including devices designed to replace or restore the structure and function of blood vessels. Whether the question(s) raised is pending in the applicant's case before any officer of Customs, Appellate Tribunal or any Court of Law? 1.38. The Applicant respectfully submits that no question or issue pertaining to the classification of the subject product, i.e., Solitaire AB stent, ....
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.... through the catheter and deployed across the aneurysm neck by retracting the delivery microcatheter. The nitinol structure self-expands, conforming to the vessel wall and creating a stable scaffold. After the stent is deployed, a second microcatheter is navigated through the stent struts into the aneurysm sac, and detachable Solitaire AB Stents are delivered and packed until adequate filling is achieved. The coils promote thrombosis inside the aneurysm, effectively isolating it from normal circulation. The stent ensures that coils remain securely within the aneurysm and prevents migration into the parent vessel. Fluoroscopic imaging is performed to confirm correct stent expansion, secure coil placement, and continued patency of the parent vessel. iv. The Solitaire AB Stent is designed to provide structural support to the parent blood vessel while facilitating coil embolization treatment. The stent remains permanently implanted in the patient's body to achieve therapeutic benefit. 2.6. CTI 9021 39 00 - OTHER ARTIFICIAL PARTS OF THE BODY i. Sub-heading 9021 39 00 covers "Other artificial parts of the body"- a residual category for artificial body parts that ....
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...., comprising a plate of vulcanised rubber, plastics or metal to which the false teeth are fitted. (4) Other articles such as, prefabricated metal crowns (gold, stainless steel, etc.) used for the protection of real teeth; cast tin bars ("heavy bars") for weighting and increasing the stability of dentures; stainless steel bars for reinforcing vulcanised rubber dental plates; various other dentists' accessories, clearly identifiable as such, for making metal crowns or dentures (sockets, rings, pivots, hooks, eyelets, etc.). (C) Other artificial parts of the body, e.g., arms, forearms, hands, legs, feet, noses, artificial joints (e.g., for hips, knees), and tubes of synthetic fabric for replacing blood vessels and heart-valves. The heading excludes pieces of bone or skin for grafting, in sterile containers (heading 30.01) and bone reconstruction cements (heading 30.06). This sub-heading covers devices that wholly or partially replace defective parts of the body and usually resemble them in appearance. The defining characteristic is replacement of existing body parts or structures. The examples illustrated in para (C) of the Explanatory Notes are also on tho....
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....f hearing aids 9021 90 90: Other ii. Applicability to Solitaire AB Stent a. The Solitaire AB Stent falls within the scope of heading 9021 but does not fit within the specific sub-headings 9021 10 to 9021 50. Therefore, it falls under the residual category CTH 9021 90 "Other." b. The stent is an appliance "implanted in the body, to compensate for a defect or disability" and it is implanted to treat cerebral aneurysms by providing scaffolding support and facilitating coil embolization, which are bodily defects or medical conditions requiring intervention. c. Not an Artificial Body Part: As established above, the stent does not replace any body part and therefore cannot be classified under sub-headings 9021 31 to 9021 39. d. Falls Under "Other": By elimination, the stent falls under CTH 9021 90 - "Other." Since it is not a part or accessory of a hearing aid (9021 90 10), it is classified under CTI 9021 90 90. 2.10. APPLICATION OF GENERAL RULES FOR INTERPRETATION i. GIR Rule 1: Classification is determined according to the terms of the headings and Section/Chapter Notes: a. Heading 9021 covers: "Orthopaedic appl....
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....oes not satisfy the essential characteristics of CTI 9021 39 00. The issue is not choosing between two equally applicable descriptions and rather, only one description (9021 90 90) applies because the stent fails the definitional test for artificial body parts. b. The Explanatory Notes explicitly states that artificial parts must "wholly or partially replace defective parts of the body." The Solitaire AB Stent does not replace and it provides scaffolding support. This is a qualitative difference, not a matter of specificity. iv. CONCLUSION UNDER GENERAL RULES FOR INTERPRETATION a. Application of GIR Rules 1 and 6 leads unambiguously to classification under CTI 9021 90 90. b. The Solitaire AB Stent falls within heading 9021 (Rule 1) as an implanted medical appliance. Within the subheadings, it does not qualify as an artificial body part (9021 39 00) because it does not replace any body structure - it provides internal scaffolding support to existing blood vessels while facilitating coil embolization. The WCO Explanatory Notes' emphasis on "replacement" and "resemblance" excludes the Solitaire AB Stent from 9021 39 00. c. By eliminatio....
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.... Personal hearing in the matter was conducted through virtual mode on 25.11.2025, wherein the authorized representatives of the applicant attended the same and reiterated facts which were already submitted in the application. No one attended the PH on behalf of the Department. 4. Additional Submission of the Applicant: 4.1. It is submitted that the applicant proposed the following competing tariff entries for classification of the impugned product: Competing entry 1 Competing entry 2 Tariff entry 9021 39 00 9021 90 90 Heading Description Other artificial parts of the body Others 4.2. The applicant had proposed classification of the product under sub-heading 9021 39 00 on the grounds that the product meets the essential characteristics of an artificial part of the body intended to compensate for a defect or disability. The applicant has further relied on the General Rules for Interpretation, particularly Rule 3(a), to support that when two or more headings are under consideration as probable entry, the classification should be made under the heading which provides the most specific description. Accordingly, it is submitted that sub-hea....
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....ing coil embolization. 4.5. Before we proceed to provide our submission in respect of classification under 9021 39, it is important to understand the coverage of products under 9021 39 vis-à-vis 9021 90. In terms of explanatory notes (EN), 9021 39 covers "other artificial parts of the body." Relevant extract of EN reproduced below for reference: EN 9021(III)(C) covers: (III) Artificial Limbs, Eyes, Teeth and Other Artificial Parts of The Body These wholly or partially replace defective parts of the body and usually resemble them in appearance. (A) ... (B) ... (C) Other artificial parts of the body, e.g., arms, forearms, hands, legs, feet, noses, artificial joints (e.g., for hips, knees), and tubes of synthetic fabric for replacing blood vessels and heart valves. 4.6. Further, 9021 90 covers "Other". Relevant extract of EN reproduced below for reference: (V)OTHER APPLIANCES WHICH ARE WORN OR CARRIED, OR IMPLANTED IN THE BODY, TO COMPENSATE FOR A DEFECT OR DISABILITY This group includes: (1) Speech aids for persons having lost the use of their vocal cords as a result of an injury or a surgic....
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....es, may include standalone assistive appliances (e.g., electronic aids) or accessories/parts for 9021 devices. Implantability/Wearability Often permanently implanted (e.g., heart valves, stents, SOLITAIRE AB STENTs) or externally worn (e.g., prosthetic limbs, eyes). Generally worn, carried, or implanted electronic aids; also includes non- implantable parts/accessories (e.g., connectors, valves). Function Specificity Mimic, replace, or structurally compensate for the form or function of the body part. Support body function or mitigate disability without being a direct anatomical replacement. Medical Use Cardiovascular, orthopedic, reconstructive, and dental applications. Assistive or therapeutic aids (speech, vision, insulin delivery), and components/parts for prosthetic devices. Examples Artificial limbs, eyes, teeth; artificial heart valves; vascular stents; SOLITAIRE AB STENTs; orthopedic implants. Speech aids, electronic aids for the blind, insulin pumps; connectors, valves, fittings for prosthetic/implant devices. Customs Classification Focused on functional or structural anatomical replacement/support devices. Based on residual cove....
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....sents a technological progression rather than a change in therapeutic purpose. Therefore, such devices should continue to fall within the ambit of "artificial parts of the body" under sub-heading 9021 39 00. 4.10. Additionally, it is important to note that when the Explanatory Notes do not explicitly cover newer medical technologies, classification should be determined by referring to comparable items that existed at the time the Notes were drafted. Reliance may also be placed on US CBP Ruling E89824, which specifically pertains to an embolic liquid and contains a similar observation. The relevant extract is reproduced below for reference: EN III to HS 90.21 does state that they "wholly or partially replace defective parts of the body ... " Normally an embolism is avoided whenever possible, instead of being produced artificially, as here. However, we believe the EN language has to be interpreted noting that this item did not exist at the time the EN was written. It was true at the time of its writing that the only artificial body parts that achieved a medically necessary purpose were ones that replaced defective parts, such as the tubes which replace damaged blood vesse....
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....defect or disability but are not artificial body parts in themselves. The latter group primarily covers electronic or assistive devices, for example speech aids, electronic aids for the blind, or insulin pumps, which support or compensate for a disability without being a structural replacement of anatomy. Accordingly, classification under 9021.90 is appropriate only where the item is either a part/accessory intended solely or principally for use with a 9021 device, or a compensatory appliance of the type described in the Explanatory Notes. 4.12. In contrast, the Solitaire AB Stent is neither an accessory nor an external assistive electronic device. It is an implantable, biocompatible prosthetic component designed to perform a therapeutic structural function within the human body. Once deployed across the aneurysm neck, it acts as an internal scaffold that enables secure placement and retention of Solitaire AB Stents inside the aneurysm sac, while simultaneously stabilizing and supporting the compromised vessel segment. By facilitating coil embolization and compensating for the underlying vascular defect, the device performs a corrective anatomical function that clearly places....
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....nction fully aligns it with the intent of subheading 9021.39.00 as an artificial part of the body. 4.15.4. Prosthetic definition includes functional compensation: "Artificial parts of the body" extends beyond physical replacement to devices that compensate for functional defects. Modern biomedical practice recognizes implants like stents as prosthetic devices serving structural and functional correction. Hence, the SOLITAIRE AB STENT qualifies under sub-heading 9021.39. 4.15.5. Explanatory Notes have provided examples, not prescribed limitation: The Explanatory Notes have mentioned "synthetic fabric tubes for replacing blood vessels" merely as examples. They do not impose a restrictive condition. CTH 9021 covers all implants designed to replace or compensate for body parts or their functions, regardless of their structural form, since structural form have been rapidly changing due to technological progress. 4.15.6. Specific Subheading Alignment: While the product falls under CTH 9021, it meets the criteria of "artificial parts of the body" under subheading 9021.39, which covers implantable prosthetic devices. Subheading 9021.90 is limited to accessories and assistive appli....
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....cal use involves a structured sequence comprising stent deployment, coil embolization and post-deployment angiographic verification to confirm correct stent expansion. Further, the applicant in his application contended that the impugned goods merit classification under CTI 9021 39 00, which is meant for 'artificial part of body'. 5.2.1 I note that the jurisdictional Commissionerate in its comments has observed that the Solitaire AB Stent, though an implantable medical device, functions by providing a scaffold across the aneurysm neck and facilitating secure placement of embolization coils and does not replace, restore, or resemble any anatomical structure. They have taken support of HSN Explanatory notes which explain that "artificial parts of the body" under CTI 9021 39 00 are those which wholly or partially replace defective body parts, the Solitaire AB Stent does not satisfy this criterion. Since it also docs not fall within any of the specific subheadings 9021 10 to 9021 50, the Commissionerate concludes that the device is appropriately classifiable under the residual entry CTI 9021 90 90, being an appliance implanted in the body to compensate for a defect or disabi....
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.... human eye (sclera, iris, pupil). They may be of single or of double shell types. (2) Intra-ocular lenses. Artificial eyes for tailors dummies, for furs, etc., are excluded (generally classified heading 39.26 or 70.18); artificial eyes identifiable as parts of dolls or of toy animals fall in heading 95.03 or in heading 70.18, if they are of glass (B) Artificial teeth and dental fittings, for example: (1) Solid artificial teeth, usually made of porcelain or plastics (acrylic polymers in particular). These may be "diatoric" teeth having a small number of holes into which the fixing material penetrates (generally molars), or may be fitted with two metallic pins for fixing (generally incisors and canines) or with a groove for sliding on to metal ridge fixed to the dental plate (also usually incisors and canines). (2) Hollow artificial teeth, also made of porcelain or plastics and with the external shape of teeth (incisors, canines or molars). According to the method of fixing, they are called "pivot teeth" (placed on a small metallic pin or pivot fitted into the prepared root), or "crowns" (fitted by means of artificial resin on to ....
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....ce audible speech. (2) Pacemakers for stimulating defective heart muscles. These are roughly the size and weight of a pocket watch and are implanted beneath the skin of the patient's chest. They incorporate an electric battery and are connected by electrodes to the heart, which they provide with the impulses necessary for its functioning. Other types of pacemakers are used to stimulate other organs (for example, the lungs, the rectum or the bladder). (3) Electronic aids for the blind. These consist essentially of an ultrasonic transmitter-receiver powered by an electric battery. The frequency variations resulting from the time taken for the ultrasonic beam to travel out to an obstacle and be reflected back enable the user, through an appropriate device (e.g., an internal ear-piece), to detect the obstacle and judge its distance. (4) Appliances implanted in the body, used to support or replace the chemical function of certain organs (e.g., secretion of insulin). PARTS AND ACCESSORIES Subject to the provisions of Notes 1 and 2 to this Chapter (see the General Explanatory Note), parts and accessories of apparatus or appliances of this heading....
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.... 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. 5.3.5 I observe that the applicant has argued that "usually resemble them in appearance" is descriptive and should not be limiting, provided examples of stents as modern equivalents. In this regard, I note that while resemblance is not an absolute test, substitution or replacement of anatomy is a non-negotiable legal condition for an item to fit within CTI 9021 31 00 and 9021 39 00. The examples cited in the Explanatory Notes are limbs, joints, graft tubes, heart valves and all these act by structural substitution of a defective or missing anatomical part with an artificial equivalent or inlay that assumes the anatomical role of the substituted part. 5.3.6 I further observe that 'Solitaire AB stent' is used inside brain blood vessels (intracranial) during endovascular treatment acting as a support frame (scaffold) across the aneurysm opening, keeping Solitaire AB Stents securely in place, preventing them from slipping into the main vessel (parent artery), and ensuring the aneurysm is safely....