TaxTMI 
TaxTMI 
2026 (1) TMI 864
X X X X Extracts X X X X
X X X X Extracts X X X X
.... 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 Annuloplasty Bands/Rings (hereinafter referred to as "the product", "the product under consideration", or "the product in question") for use in medical and surgical procedures. The product is a flexible ring or band composed of polyester fabric, designed for use in annuloplasty, a surgical technique employed to repair a leaking heart valve. The device 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. 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 varian....
X X X X Extracts X X X X
X X X X Extracts X X X X
....s, they collectively fall under the broader category of "Annuloplasty Band/Ring." These products perform an identical functional purpose but differ in size, shape, and material composition. These variations do not appear to influence the classification of the product under consideration as their functionality remains consistent across the various material numbers. Therefore, a single application is being submitted to request a ruling on their appropriate classification. Product applications, functions, and other technical capabilities 1.6. Product Description As mentioned above, the Annuloplasty Band/ Ring is a prosthetic medical device used in cardiac valve repair surgery, primarily to reshape and stabilize the annulus (the ring-like base of a heart valve). It is commonly used in mitral and tricuspid valve repairs to correct conditions like valvular regurgitation or annular dilation, where the valve fails to close properly. When the annulus becomes dilated, distorted, or dysfunctional, it can prevent the valve leaflets from closing properly, leading to regurgitation (backward blood flow). The annuloplasty ring reinforces and reshapes the annulus, enabling effective valve ....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ucted to maintain a fixed annular shape, these devices are typically indicated in cases of ischemic or degenerative valve regurgitation, where structural support is paramount. * Semi-Rigid Rings: Designed to offer partial flexibility, these rings provide a balance between annular stabilization and physiological motion, making them suitable for a broader range of valve repair scenarios. * Flexible Rings/Bands: Engineered to conform to the dynamic motion of the cardiac annulus, these devices are preferred when preservation of native annular function is clinically desirable. 1.9.2. Classification by Annular Coverage * Complete Rings: These devices encircle the entire annulus, offering 360-degree support, and are generally used when comprehensive annular remodelling is required. * Partial Rings (Bands): These cover only a segment of the annulus, typically the posterior portion, and are employed in cases where targeted support is sufficient. 1.10. Product Images: Chain of events leading to the present Application: 1.11. The applicant has been importing the medical device 'Annuloplasty Band/Ring' into India, classifying the same und....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ces, not mechanical support structures like annuloplasty rings. 9021 90 Other 9021 90- Another relevant subheading if the product does not fall in any of the above subheadings 1.14. Hence, it is evident that prima facie there are two plausible classifications for the product, viz. sub-heading 9021.90 'a residual subheading under Heading 9021', which covers other devices designed to support or replace parts of the human body not specifically provided for elsewhere under the heading; and sub-heading 9021.39, which more precisely pertains to other artificial parts of the body. This ambiguity may be arising from the progressive and multidisciplinary nature of modern medical technologies, wherein certain implantable devices may exhibit features and functionalities that conceptually align with both subheadings. 1.15. Given the product's implantable nature and its role in anatomical and functional restoration, a detailed analysis is required to determine the most appropriate classification between the two competing tariff entries. 1.16. In view of the classification ambiguity and the possibility of answering to the scope of the relevant subheadings, the appli....
X X X X Extracts X X X X
X X X X Extracts X X X X
.... reference and have no legal standing. Rule 1: "The titles of Sections, Chapters and sub-Chapters are provided for ease of reference only; for legal purposes, classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes and, provided such headings or Notes do not otherwise require, according to the following provisions." 1.19.2. Further, GRI 3(a) of the Harmonized System provides that when goods are, prima facie, classifiable under two or more headings, classification shall be determined by the heading that 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 ....
X X X X Extracts X X X X
X X X X Extracts X X X X
....eyes, and hearing aids. The heading also includes appliances worn externally or implanted surgically, provided they serve a structural or functional medical purpose. The relevant description of Heading 9021 is reproduced below for reference: 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. 1.22. In accordance with the General Rules for the Interpretation (GRI)- Rule 1 of the Harmonized System, 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. 1.23. For ease of reference, the relevant extract of the Schedule 1 to ....
X X X X Extracts X X X X
X X X X Extracts X X X X
....uman body. These include wearable or implantable devices like speech aids, electronic aids for the blind, and insulin pumps, which may not be artificial body parts but serve a support device to compensate defect. Classification under 9021.90 depends on whether the item is either a part/accessory suitable solely or principally for use with a 9021 device, or a standalone appliance that aligns with the functional scope of Heading 9021. 1.28. Accordingly, any medical device or component that is designed to compensate for a defect or disability in the human body but is not specifically classified under any other subheading of 9021 and is either a standalone appliance or a part/accessory identifiable as being used solely or principally with a device under Heading 9021, should be appropriately classified under HSN code 9021.90.90 of the Indian Customs Tariff. 1.29. 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 HS code 9021.90 Description Other artificial body parts not elsewhere specified Other appliances and parts/accessories of devices ....
X X X X Extracts X X X X
X X X X Extracts X X X X
.... assist, regulate, or support physiological functions without replicating or replacing anatomical structures. In contrast, HS Code 9021.39 is specifically intended for "other artificial parts of the body," encompassing devices that wholly or partially replace or support defective anatomical components. These devices are classified under this heading when they are designed to replicate both the structural and functional characteristics of the natural body part they substitute. Given the Annuloplasty Ring's role in reinforcing and reshaping the heart valve annulus, it aligns more closely with the anatomical purpose outlined under HS Code 9021.39. 1.32. The terms anatomical and physiological, as used above, refer to two distinct aspects of the human body. Anatomical pertains to the structure-the physical parts of the body such as bones, organs, and tissues (e.g., heart valves, spinal vertebrae, or limbs). In contrast, physiological relates to the functions and processes carried out by these structures, such as blood circulation, breathing, or hormone regulation (e.g., the pumping action of the heart or the release of insulin by the pancreas). This distinction is crucial in medi....
X X X X Extracts X X X X
X X X X Extracts X X X X
....lantation. The ruling recognizes such devices as falling within the scope of "other artificial parts of the body" under Heading 9021. Given the functional and anatomical similarities-both devices being surgically implanted and integral to restoring heart valve function-the rationale adopted in this ruling provides a strong basis for classifying the Annuloplasty Band/Ring under HSN Code 9021.39.00 of the Indian Customs Tariff. 1.37. Further, reliance is also placed on another CBP Ruling No. R03500, which pertains to the classification of implantable cardiac stents under subheading 9021.39. These small, expandable mesh tubes, typically made of metal or polymer, are implanted in coronary arteries to restore and maintain blood flow in patients with coronary artery disease. Though deployed in a different anatomical region, cardiac stents share a comparable therapeutic objective with annuloplasty rings-both are permanently implanted prosthetic devices designed to restore and support critical cardiovascular functions. The Annuloplasty Ring, affixed to the heart valve annulus, reshapes and reinforces the valve structure to ensure proper closure and uninterrupted circulatory flow. The fu....
X X X X Extracts X X X X
X X X X Extracts X X X X
....body parts. 1.39. The Applicant respectfully submits that no question or issue pertaining to the classification of the subject product, i.e., Annuloplasty Band/Ring, is pending for consideration before any officer of Customs, the Appellate Tribunal, or any Court of Law, in the Applicant's case. 1.40. In light of the facts, relevant legal provisions and our submissions made in the above paragraphs, our humble prayer before your good self is as follows: * Confirm that the product under consideration is classifiable under tariff entry 9021 39 00 as Other; Other artificial parts of the body. 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 18.11.2025 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 stated that they have imp....
X X X X Extracts X X X X
X X X X Extracts X X X X
....y or partially replace defective parts of the 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 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 e....
X X X X Extracts X X X X
X X X X Extracts X X X X
....e band/ring is deployed around a functioning valve annulus and it does not replace an absent, defective, or removed body part. The valve annulus around which it is deployed continues to exist; the band/ring provides external structural support and reinforcement to the existing annulus while facilitating proper valve closure. c. Does Not Resemble Body Parts: The Explanatory Notes state artificial parts "usually resemble them in appearance." The Annuloplasty Band/Ring does not resemble any natural anatomical structure and it is a fabric-reinforced device that bears no resemblance to heart valves, valve annulus, or any body part. d. The fundamental purpose of the band/ring is to provide structural support for annular reshaping and stabilization. This is different from replacing or restoring normal anatomical structure. The band/ring supports and reinforces an existing annulus rather than substituting for a missing or removed structure. e. The Explanatory Notes specifically mention "heart-valves" as examples of artificial parts of the body and these are prosthetic valves that replace damaged or diseased heart valves. In contrast, the Annuloplasty Band/Ring do....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ted in the body, to compensate for a defect or disability." b. The Annuloplasty Band/Ring clearly falls within the scope of heading 9021 because it is an appliance implanted in the body to compensate for defects or disabilities (valvular regurgitation caused by annular dilation). c. Conclusion under Rule 1: The Annuloplasty Band/Ring is prima facie classifiable within heading 9021. 2.10.2. GIR Rule 6: Classification of goods in subheadings shall be determined according to the terms of those subheadings a. Having established that the Annuloplasty Band/Ring 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: 9021 39 00 vs 9021 90 90 i. The critical question is whether the Annuloplasty Band/Ring qualifies as "Other artificial parts of the body" under CTI 9021 39 00 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 An....
X X X X Extracts X X X X
X X X X Extracts X X X X
....ading 9021 90 90 "Other" - a category for medical implants and devices within heading 9021 that do not fit specific subheading descriptions. 2.11. SUMMARY a. Proposed Classification: 9021 90 90 - Other b. Rationale: The Annuloplasty Band/Ring is a medical device implanted in the body to treat valvular regurgitation by providing structural support and reinforcement to reshape and stabilize the valve annulus. 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 Annuloplasty Band/Ring does not replace any body part and it is deployed ....
X X X X Extracts X X X X
X X X X Extracts X X X X
.... entry under sub-heading 90219090. 4.3. However, based on the comments received from the Office of the Principal Commissioner of Customs (Air Cargo), Chennai vide File No. GEN/LGL/OTH/124/2025-GR-5B dated 24.11.2025, we understand that between the two competing entries, sub-heading 9021 39 00 and sub-heading 9021 90 90, the said office is of the view that the latter appears more appropriate, as the product is not specifically covered elsewhere under the CTH 9021. 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 Annuloplasty band does not resemble any natural anatomical structure - it is a fabric-reinforced device that bears no resemblance to heart valves, valve annulus, or any body part. 4.4.2. Doesn't replace any body part: The band/ring is deployed around a functioning valve annulus and it does not replace an absent, defective, or removed body part. The valve annulus around which it is deployed continues to exist; the band/ring pr....
X X X X Extracts X X X X
X X X X Extracts X X X X
.... consist essentially of an electronic impulse generator. When pressed against the neck, for example, they generate vibrations in the cavities of the throat which are modulated by the user to produce 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 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)....
X X X X Extracts X X X X
X X X X Extracts X X X X
....rts, accessories, or standalone aids compensating disability but not artificial body parts. 4.8. Applicability of CTH 90213900 to the product in question: 1. Basis above Explanatory Notes, it is evident that sub-heading 9021.39 covers "other artificial parts of the body," which include devices that wholly or partially replace, reinforce, or functionally compensate for defective or diseased anatomical structures. The reference to "tubes of synthetic fabric for replacing blood vessels, heart valves" illustrates that this heading extends to implantable devices that restore or support essential physiological function. 2. The examples cited in the Explanatory Notes must also be understood in the context of the medical technology available when those notes were drafted, a period in which open surgical vascular grafts and complete heart valve replacement were the primary means of treating severe cardiovascular damage. While these examples describe earlier prosthetic methods, they reflect the consistent underlying principle that implantable devices designed to correct or compensate for defective anatomical parts fall within this sub-heading. 3. A similar progr....
X X X X Extracts X X X X
X X X X Extracts X X X X
....s which replace damaged blood vessels. All Tariffs must be interpreted to include new items that fit the legal language of the provision. Explanatory material cannot be used to defeat the language's intention. 7. Accordingly, the aforesaid ruling reinforces that novel medical products should be classified in line with the broader tariff intent, even where explanatory notes may appear outdated or incomplete. 8. Similarly, and without prejudice to the above submissions, it is respectfully submitted that even if the product in question is not expressly enumerated in the text of CTH 9021 or its corresponding Explanatory Notes, classification under subheading 9021.39 is nevertheless supported by General Rules of Interpretation Rule 4. Under GIR 4, goods which cannot be classified by reference to the terms of the headings or by applying the preceding Rules are to be classified under the heading appropriate to the goods to which they are most akin. In the present case, the device serves the same therapeutic purpose as the synthetic vascular grafts and other implantable prosthetic devices already recognized under CTH 9021 namely, to compensate for, reinforce, or resto....
X X X X Extracts X X X X
X X X X Extracts X X X X
....upport 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. 4.10. In contrast, an annuloplasty band is neither an accessory nor an external assistive device. It is an implantable, biocompatible prosthetic component designed to restore structural integrity within the heart. Once implanted, it provides durable anatomical correction by reinforcing and reshaping the valve annulus, thereby compensating for the underlying functional defect in the native heart valve. By performing this corrective prosthetic function inside the human body, the annuloplasty band falls squarely within the scope of "artificial parts of the body" under CTH 9021.39. 4.11. Unlike appliances classified under subheading 9021.90, which are intended primarily to assist, support, or regulate physiological functions, an annuloplasty band provides a direct structural correction to a defective cardiac valve annulus. Its role is restorative and anatomi....
X X X X Extracts X X X X
X X X X Extracts X X X X
....etic devices serving structural and functional correction. Hence, the Annuloplasty band qualifies under sub- heading 9021.39. 4.13.5. Therapeutic restoration, not Pathological Obstruction: The Annuloplasty band restores the normal function of a diseased heart valve by reinforcing and reshaping the annulus, ensuring proper leaflet closure and preventing regurgitation. Its role is corrective and structural, not merely supportive, aligning it with other implantable prosthetic devices under CTH 9021 designed to compensate for defective anatomical parts. 4.13.6. Explanatory Notes have provided examples, not prescribed limitation: The reference in the Explanatory Notes to "heart valves" is illustrative of the types of implantable prosthetic devices covered under CTH 9021. It does not restrict the heading to devices that fully replace a valve. Modern implants such as annuloplasty bands, which restore the functional integrity of the native valve without complete replacement, fall squarely within the scope of "artificial parts of the body" under subheading 9021.39. 4.13.7. Specific Subheading Alignment: While the product falls under CTH 9021, it meets the criteria of "artificial pa....
X X X X Extracts X X X X
X X X X Extracts X X X X
....r 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 Annuloplasty Bands/Ring, though an implantable medical device, functions by providing structural support and reinforcement to the existing valve annulus by facilitating optimal valve repair 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 Annuloplasty Bands/Ring does not satisfy this criterion. Since it also does 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 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 GR....
X X X X Extracts X X X X
X X X X Extracts X X X X
....iable 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 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.) use....
X X X X Extracts X X X X
X X X X Extracts X X X X
....rodes 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 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 denta....
X X X X Extracts X X X X
X X X X Extracts X X X X
....pliance 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 is not restrictive, 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 understand that 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 Band....