AI OCR 
TaxTMI 
TaxTMI 
TaxTMI 
2026 (1) TMI 59
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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 Embolization coil (hereinafter referred to as "the product", "the product under consideration", or "the product in question") for use in medical and surgical procedures. It is a small, implantable medical device used to block or reduce blood flow within a blood vessel. It is commonly used to treat aneurysms, arteriovenous malformations (AVMs), and tumors by promoting clot formation at the target site. 1.4. The Applicant has approached the Customs Authority for Advance Rulings, New Delhi for determining the appropriate classification of the product. Although the product is imported under various material codes and descriptions, all variants perform substantially similar functions and fall within the general category of ....
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.... discussing about the implantation procedure, it is important to understand certain key medical terms: * Embolization refers to a minimally invasive endovascular procedure in which an embolic agent, such as a coil or particle, is introduced into a blood vessel to intentionally block blood flow to a specific area. This is commonly performed to prevent rupture or bleeding in abnormal vascular structures. * Aneurysm is a localized, abnormal dilation or ballooning of a blood vessel wall, typically resulting from weakness in the vessel structure. In the intracranial context, aneurysms pose a risk of rupture, leading to potentially life-threatening haemorrhage. * Thrombosis denotes the formation of a blood clot (thrombus) within a blood vessel, which can obstruct blood flow. In the context of embolization, inducing thrombosis within an aneurysm sac is a therapeutic objective to achieve permanent occlusion of the aneurysm. 1.9. Procedure of Embolization Coil: * Microcatheter Navigation Under fluoroscopic guidance, a microcatheter is navigated intravascularly via an appropriate access point (e.g., femoral artery) to the site of the intracrani....
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....ation device designed for the treatment of intracranial aneurysms. It consists of a pre-formed platinum coil, delivered through a micro catheter and detached at the treatment site using an advanced detachment system. Based on its nature, design, and intended therapeutic function, the device squarely falls within the ambit of Heading 9021. Accordingly, there exists no prima facie ambiguity in respect of the classification of the Embolization Coil under the said Heading at the four-digit level. 1.12.3. However, it is understood from the trade circles that there are divergent practices being followed with respect to the classification of the products under consideration at the 6-digit level. Specifically, while some importers are classifying the product under sub-heading 9021.39, which covers 'Other artificial parts of the body,' others are classifying it under sub-heading 9021.90, which is a residual category for 'Other' appliances of CTH 9021, which are not elsewhere specified. This divergent practice is creating ambiguity regarding the appropriate classification of the product at the sub-heading level. 1.12.4. It is pertinent to mention that there are no alter....
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....ed a preliminary assessment of the product's characteristics and medical application. Based on this assessment, the applicant is of the considered opinion that the "Embolization Coil" 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 intended for the treatment of intracranial aneurysms; and that being so, it gets covered under the subheading 9021.39. Since the competing subheading 9021.90 is a residual entry, covering other devices of heading 9021 (emphasis supplied), for a product to be covered under this residual entry, there must exist some basis for the product to be not covered by the scope of preceding entries at the single (-) level under the said CTH 9021, including subheading 9021.39. 1.13. To substantiate this position and resolve the ambiguity, the present application undertakes a reasoned and systematic interpretation of the relevant tariff entries. This includes a comparative analysis of the scope, legal notes, and explana....
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....ation to those goods, even if one of them gives a more complete or precise description of the goods. 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. Rule 6: "For legal purposes, the classification of goods in the subheadings of a heading shall be determined according to the terms of those subheadings and any related subheading notes and, mutatis mutandis, to the above rules, on the understanding that only subheadings at the same level are comparable. For the purposes of this rule, the relative section, chapter and subchapter notes also apply, unless the context otherwise requires." Classification of the product under consideration under CTH 9021. 1.16. Chapter 90 of the Indian Customs Tariff Act encompasses a broad spectrum of instruments and apparatus used in scientific, medical, optical, and technical domains. These include....
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....he 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 Orthopedic 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 appliances - Other artificial parts of the body: 9021 31 00 -- Artificial joints 9021 39 00 -- Other 9021 90 - Other 9021 90 90 --- Other 1.20. Furthermore, the World Customs Organization (WCO) Explanatory Notes to Heading 9021 clarify that subheading 9021.39 pertains to "other artificial parts of the body." This subheading is not limited to devices that physically replace missing anatomy, but also includes implantable devices that compensate for or correct defective anatomical structures by assuming or supporting their function. Examples include vascular stents, which ke....
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.... 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.g., electronic aids) or accessories/parts for 9021 devices. Implantability / Wearability Often permanently implanted (e.g., heart valves, stents, embolization coils) 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,....
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....atment of intracranial aneurysms, arteriovenous malformations (AVMs), fistulas, tumors, and vascular hemorrhages. Once delivered through a microcatheter, the coil is designed to conform to the aneurysm cavity, achieve dense packing, and promote thrombosis (blood clot formation). This results in durable occlusion of the abnormal vessel and restoration of vascular stability, thereby preventing rupture, re-bleeding, or abnormal blood flow. 1.28. Unlike appliances under subheading 9021.90, which primarily assist or regulate physiological functions, the Embolization Coil directly restores the anatomical integrity of defective blood vessels. Its function is structural rather than regulatory, aligning it with subheading 9021.39, which covers "other artificial parts of the body." Classification under sub-heading 9021.39 is, therefore, technically more appropriate and legally correct, consequently, classification under residual sub-heading 9021.90 would be inappropriate. 1.29. The distinction between anatomical and physiological aspects is critical in HSN classification of medical devices. Anatomical relates to physical structures of the body (bones, tissues, organs), and devices that....
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....und not to be drugs nor instruments, but rather implantable devices that remain indefinitely within the patient's body to achieve therapeutic benefit. CBP determined they qualify as "other artificial parts of the body" under subheading 9021.39. Although microspheres and the Embolization detachable coil differ in form, both serve the same anatomical purpose: to occlude a vascular defect and provide structural support. The microsphere ruling thus reinforces the classification of the Embolization coil under subheading 9021.39, by virtue of both its permanent implantable nature and its function in restoring anatomical integrity through vascular occlusion. 1.33. In conclusion, the Applicant respectfully submits that the product under consideration Embolization coil appears to be most appropriately classifiable under subheading 9021.39.00, based on the following grounds: * The Embolization Coil is a surgically implantable, biocompatible device made from platinum- tungsten alloy, specifically designed to occlude abnormal vascular cavities such as aneurysms, AVMs, and fistulas. By promoting thrombosis and ensuring durable occlusion, it restores the structural integrity of d....
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....er consideration is classifiable under tariff entry 9021 39 00 as Other; Other artificial parts of the body; and * Allow us to present our case in a personal hearing before your good self-prior to issuance of any Order. 2. Comments of the Port Commissionerate: 2.1 As per the provision of CAAR Regulation, 2021, the complete application of the applicant was provided to the concerned Custom Port, and requested to furnish the requisite comments in the instant matter. The port authority vide letter dated 10.11.2025 furnished its comments, as follows: 2.2. The Importer is having IEC CODE: 3496003171 hence is eligible in terms of c(i). 2.3. As per the available records the specific matter is not pending in any appellate tribunal or Court. 2.4. The Importer has started importing the said goods vide BE 3420939 dated 22.07.2025 bearing description "00847536045002 Concerto Detachable Coil System-PGLA Fibre PV-12-30-HELIX" and others under CTI 90219090 hence the activity is ongoing in INMAA4. 2.5. CLASSIFICATION ANALYSIS - EMBOLIZATION COIL (CONCERTOTM DETACHABLE COIL SYSTEM) 2.6. THE PRODUCT - EMBOLIZATION COIL i. The importer vide application for advanc....
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....he body and usually resemble them in appearance. They include: (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." (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. They include: (A) Artificial ocular fittings: (1) Artificial eyes. These are usually made of plastics or glass to which small quantities of metallic oxides have been added in order to imitate the features and colouring of the various parts of the human eye (sclera, iris. pupil). They may be of single or of double shell types. (2) Intra-ocular Lense. Artificial eyes for tailors' dummies; for furs. etc., are excluded (generally classified in heading 39.26 or 70.18); artificial eyes identifiable as parts of doll 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) ....
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....vessel - it does not replace an absent, defective, or removed body part. The blood vessel into which it is deployed continues to exist; the coil merely blocks it. c. Does Not Resemble Body Parts: The Explanatory Notes state artificial parts "usually resemble them in appearance:" The embolization coil does not resemble any natural anatomical structure - it is a small metallic coil/spring-like device that bears no resemblance to blood vessels, organs, or any body part. d. The fundamental purpose of the coil is to create an artificial blockage (embolism) where none existed naturally. This is the opposite of replacing or restoring normal anatomical structure or function. The coil intentionally causes vascular occlusion - it creates a therapeutic abnormality rather than replacing an abnormality. e The Explanatory Notes specifically mention "tubes of synthetic fabric\for replacing blood vessels"-these are prosthetic vessels that replace damaged or diseased blood vessel segments. In contrast, the embolization coil does not replace the blood vessel; it blocks a functioning vessel from the inside. f. While the coil may compensate for a defect (e.g., preve....
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....of those subheadings a. Having established that the embolization coil falls within heading 9021 under Rule 1, Rule 6 requires determination of the appropriate subheading based on the specific terms of each subheading. b. Analysis of competing subheadings: 90213900 vs 9021 90 90 i. The critical question is whether the embolization coil qualifies as "Other artificial parts of the body" under 9021 3900, or falls into the residual category 9021 90 90 "Other." ii. The WCO Harmonized System Explanatory Notes state: "These wholly or partially replace defective parts of the body and usually resemble them in appearance." iii. The embolization coil FAILS the test for 90213900 because: 1. No Replacement Function: The coil does not replace any body part. It is inserted into a functioning, existing blood vessel which remains in place - the coil merely blocks it from the inside. 2. No Resemblance: The coil does not resemble any anatomical structure. 3. Creates Dysfunction vs. Replaces Dysfunction: The coil's therapeutic mechanism is to intentionally create a blockage (embolism) where none existed. 4. The emboliz....
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.... tumors) by promoting blood clot formation and blocking blood vessels. While it falls within the scope of heading 9021 as an implanted appliance that compensates for bodily defects or disabilities, it does not satisfy the specific criteria for classification under 9021 39 00 "Other artificial parts of the body." c. The WCO Harmonized System Explanatory Notes clearly define artificial parts of the body as items that "wholly or partially replace defective parts of the body and usually resemble them in appearance." The examples provided (artificial limbs, eyes, joints, blood vessel replacement tubes, heart valves) all share the common characteristic of replacing or substituting for absent, damaged, or defective anatomical structures. d. The embolization coil does not replace any body part - it is inserted into a functioning blood vessel to intentionally create an occlusion. It does not resemble any anatomical structure in appearance. Its function is to create a therapeutic blockage, not to replace a defective structure with an artificial equivalent. e. By process of elimination, the coil does not fit within any of the specific subheadings 9021 10 through 902....
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....tion under sub-heading 9021 90 90 (Other). 4.4. Further, the Office of Principal Commissioner of Customs has primarily relied on the following to suggest classification under sub-heading 9021 90: 4.4.1. Doesn't resemble any body parts: The Explanatory Notes state artificial parts "usually resemble them in appearance." The embolization coil does not resemble any natural anatomical structure - it is a small metallic coil/spring-like device that bears no resemblance to blood vessels, organs, or any body part. 4.4.2 Doesn't replace any body part: The coil is inserted into a functioning blood vessel - it does not replace an absent, defective, or removed body part. The blood vessel into which it is deployed continues to exist; the coil merely blocks it. 4.4.3. Does not treat any defect or dysfunction rather create one: The fundamental purpose of the coil is to create an artificial blockage (embolism) where none existed naturally. This is the opposite of replacing or restoring normal anatomical structure or function. The coil intentionally causes vascular occlusion - it creates a therapeutic abnormality rather than replacing an abnormality. Further it has been mentione....
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.... (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 earpiece), 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 remain classified here. Applicability of CTH 90213900 to the product in question: 4.7. In light of the above, we have made broad comparison in table below for coverage under 902139 vs 902190: 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....
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....nthetic fabric for replacing blood vessels" reflects the medical technology available at the time those notes were drafted, when synthetic vascular grafts were the primary method for surgically replacing or reinforcing damaged blood vessels. Over time, vascular treatment has progressed substantially, and minimally invasive endovascular devices such as stents now achieve the same therapeutic objective by restoring patency and providing structural support from within the vessel without the need for open surgery. Although the techniques have evolved, both synthetic grafts and stents address the same clinical requirement of compensating for diseased or compromised vascular segments and therefore remain functionally comparable prosthetic devices. In a similar manner, embolization coils are used to manage vascular abnormalities such as aneurysms, hemorrhages, and arteriovenous malformations by creating a controlled occlusion that stabilizes or redirects blood flow. Through this function, embolization coils operate as implantable prosthetic devices intended to correct or compensate for defects within the vascular system, in the same clinical sense that stents and synthetic grafts perform ....
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....21 namely, to compensate for, reinforce, or restore the function of defective or compromised anatomical structures. Although the underlying medical technology has evolved from surgical grafts to minimally invasive endovascular implants, the essential nature, intended function, and clinical role of the devices remain substantially comparable. Accordingly, under GIR 4, the product is most akin to such prosthetic implants and therefore, merits classification under subheading 9021.39. 4.13. In this regard, reliance is also placed on CBP ruling NY N040455, which deals with the classification of vascular microspheres used for embolization under subheading 9021.39.0000. These microspheres designed as solid, inert spheres and injected for vascular embolization to intentionally block blood vessels were found not to be drugs nor instruments, but rather implantable devices that remain indefinitely within the patient's body to achieve therapeutic benefit. CBP determined they qualify as "other artificial parts of the body" under subheading 9021.39. Although microspheres and the Embolization detachable coil differ in form, both serve the same anatomical purpose: to occlude a vascular defe....
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....ficial parts of the body." Consequently, classification under residual sub-heading 9021.90 would be inappropriate. 4.18. Accordingly, the nature, function, and mode of use of the embolization coil distinguish it clearly from the items covered under the residual subheading 9021.90, which is confined to ancillary parts and external appliances, not to primary implantable prosthetic devices. Therefore, classification under sub-heading 9021.90 would be inconsistent with both the scope and the intent of that subheading. 4.19. In light of the comments received by the Office of the Principal Commissioner of Customs, the applicant requests your good office to consider following points: 4.20. Residual subheading does not apply: Subheading 9021.90.90 is restricted to assistive devices (mostly electronics) such as insulin pumps or speech aids and accessory parts. The embolization coil is a self-contained, permanently implantable prosthetic device, making classification under 9021.90.90 inconsistent with the scope and intent of that category. 4.21. Physical appearance should not be the deciding factor: Classification under CTH 9021 does not depend on physical resemblance to a body p....
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....c devices. Subheading 9021.90 is limited to accessories and assistive appliances, not implantable prosthetic parts. Therefore, 9021.39 is more specific and appropriate as per GRI 3(a). 4.27. GRI 4 supports classification by essential similarity: GRI 4 also supports this classification. Where goods are not clearly covered by specific wording or prior rules, they must be classified with those to which they are most similar. The embolization coil, by its implantable nature, biocompatibility, and role in stabilizing or correcting vascular defects, is most akin to prosthetic implants covered under subheading 9021.39. Its essential character matches that of grafts and other internal artificial devices, confirming that 9021.39 remains the correct and closest classification. 4.28. Thus, in view of the above submission, the applicant humbly submits that the appropriate classification of the product "Embolization coil" would be under sub-heading 9021 39 00 as "Other artificial parts of body". 5. Discussion, Findings & Conclusion: 5.1 Having examined the CAAR-1 application, the comments received from the jurisdictional Customs Commissionerate, Additional submission of the applican....
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.... for a defect or disability. Issue of classification: 5.3 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 1 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. Accordingly, to determine the correct classification of the impugned goods, it is necessary to examine Tariff Heading 9021 and the competing CTIs 9021 39 00 and 9021 90 90, read with the relevant Section Notes, Chapter Notes, and Explanatory Notes. The relevant tariff entries read as under: 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 appliances ....
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....artificial resin on to a previously shaped stump). (3) Dentures, whole or part, 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.). It should be noted that dental cements and other dental fillings fall in heading 30.06; the preparations known as "dental wax" or as "dental impression compounds", put up in sets, in packings for retail sale or in plates, horseshoe shapes, sticks or similar forms, and other preparations for use in dentistry, with a basis of plaster (of calcined gypsum or calcium sulphate). fall in heading 34.07. (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....
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....s of this heading remain classified here. " 5.3.2 On perusal of the entries in the table supra, it is evident that tariff heading 9021 covers "orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial teeth and dental fittings, artificial parts of the body; hearing aids; and other appliances which are worn, carried, or implanted in the body to compensate for a defect or disability". Within this tariff heading, CTI 9021 39 00 constitutes a residual sub-category under "other artificial parts of the body" which includes implantable devices not specifically enumerated elsewhere in the heading. Similarly, CTI 9021 90 90 is a residual entry under the heading 9021 90, covering "parts and accessories of hearing aids" and "others". Thus, I observe that both CTIs 9021 39 00 and CTI 9021 90 90 represent broad "other" categories, and their applicability depends on whether the impugned goods can be regarded as artificial body parts or "other" appliances under 9021 90 90 intended to compensate for a defect or disability as contemplated under Heading 9021. 5.3.3 I note that the Explanatory Notes to Heading 9021 further clarifie....
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....defect cavity to induce thrombosis and terminate flow, without substituting any anatomical segment. I find, therefore, that the goods "Embolization coil", 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. 5.3.7 Accordingly, I reject the applicant's claim for classification under 9021 39 00, on the basis that the coil 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. 5.3.8 I find that the goods viz. "Embolization coil", 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 und....