TaxTMI 
TaxTMI 
2026 (7) TMI 380
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....her" of the First Schedule to the Customs Tariff Act, 1975 (hereinafter referred to as 'the Tariff")? ii. Whether the product in question i.e., knee implants, hip implants and shoulder implants are eligible for exemption benefit under Sr No. 385 of Notification No. 45/2025-Cus dated 24.10.2025? 3. Submission by Applicant- 3.1 1 Medacta India Pvt. Ltd is a private limited company that was incorporated in the year 2025 under the Companies Act, 2013. The Applicant is engaged in import, and trading of orthopaedic solutions such as knee implants, hip implants, shoulder implants etc. The Applicant is Part of the internationally renowned Medacta group, based out of Switzerland. 3.2 Copy of certificate of incorporation of the Applicant Company is filed along with this application. 3.3 The Applicant is now proposing to import various models of "knee implants", "hip implants", "shoulder implants". Each model is sold under a unique brand name. Each model consists of numerous different components, which when fitted together form the complete system. Each component, depending on its nature, might or might not be available in differing size specifications. Details of the....
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....appliances - Artificial teeth and dental fittings 90212100 -- Artificial teeth 90212900 -- Other - Other artificial parts of the body 90213100 -- Artificial joints 90213900 -- Other 902140 - Hearing aids, excluding parts and accessories **** (Emphasis supplied) 4.6 HSN Explanatory Notes to Heading 9021 defines the term artificial body parts as parts which wholly or partially replace defective parts of the body and usually resemble in appearance. The relevant extract from the HSN 9021 is as under: (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 : 4.7 The product in question i.e., knee implant, hip implant and shoulder implant are specifically covered under Heading 9021. The relevant extract from HSN Explanatory to Heading 9021 is reproduced below for ease of reference: (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 repla....
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....tem 90211000 "Orthopaedic or fracture appliances" / 90213100 "artificial joints" 4 Short Medacta Stem (SMS) 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 5 M-Vizion Monobloc stem 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 6 Medacta shoulder system 90211000 "Orthopaedic or fracture appliances" / 90213100 "artificial joints" 7 Moto partial knee system 90211000 "Orthopaedic or fracture appliances" / 90213100 "artificial joints" 8 Mpact 3D Metal Two-hole 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 9 Masterloc 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 4.14 Alternatively, the products are classifiable as orthopaedic appliances under Tariff Item 90211000. Reliance is this regard on the decision of Smith & Nephew Healthcare Private Vs. Commissioner of Customs (Import) Air Cargo Complex, Sahar, Andheri East - 2025 (7) TMI 1346 wherein implants for knee, hip implants such as Screw Biosure, Regenesorb, Legion etc., were considered to be orthopaedic appliances. 5. THE PRODUCTS IN QUESTION ARE ELIGIBLE FOR EXEMPTION BENEFIT UNDER SR. NO. UNDER SR NO....
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....and other instruments and vocational aids specifically adapted for use of the blind (7) Assistive listening devices, audiometers (8) External catheters, special jelly cushions to prevent bed sores, stair lift, urine collection bags (9) Implants for severely physically handicapped patients including bone cement 5.3 Benefit under the aforesaid exemption is available to all products that are set out is List 21. The description in the exemption notification makes it clear that all products in the List are entitled to the exemption and all the products so mentioned are considered to be "Assistive devices, rehabilitation aids and other goods for disabled". Thus, as long as products are mentioned in List 21, it need not be separately seen whether they are "Assistive devices, rehabilitation aids and other goods for disabled", as presumption is that they are. The implants in question are Orthopaedic Appliances as described in Entry B(1) of List 21 and thereby, the implants in question are eligible for exemption benefit under Sr No. 385 of Notification 45/2025-Cus dated 24.10.2025 5.4 As per Note 6 to Chapter 90 'Orthopaedic Appliances' means appliances for ....
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....aille writing instruments (2) Hand writing equipment Braille Frames, Slates, Writing Guides, Script Writing Guides, Styli, Braille Erasers (3) Canes, Electronic aids like the Sonic Guide (4) Optical, Environmental Sensors (5) Arithmetic aids like the Taylor Frame (arithmetic and algebra types), Cubarythm, Speaking or Braille calculator (6) Geometrical aids like combined Graph and Mathematical Demonstration Board, Braille Protractors, Scales, Compasses and Spar Wheels (7) Electronic measuring equipment, such as calipers, micrometers, comparators, gauges. Gauge blocks Levels, Rules, Rulers and Yardsticks (8) Drafting, Drawing aids, tactile displays (9) Specially adapted clocks and watches B. (1) Orthopaedic appliances falling under heading No.90.21 of the First Schedule (2) Wheel chairs falling under heading No. 87.13 of the First Schedule C. Artificial electronic larynx and spares thereof D. Artificial electronic ear (Cochlear implant) E. (1) Talking books (in the form of cassettes, discs or other sound reproductions) and large- print books, braille embossers, talking....
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.... also the use of the expression 'Assistive devices, rehabilitation aids and other goods" becomes ineffective; and as seen above, the appropriate expression in such case would be "goods specified in List 30 for use of disabled". Furthermore, if the entire description is to be read together, by ignoring the punctuation mark i.e., "[comma]," then it would give absurd meaning, as can be seen from an illustrative item under (E)(7) of the List-30 'Assistive listening devices, audiometers which is assistive devices/rehabilitation aids for disabled'; Therefore, proper construction of the description under column (3) for the exemption entries at Serial No. 578/Serial No.257 would be: (i) assistive devices covered under Chapter 90 or any other chapter; (ii) rehabilitation aids covered under Chapter 90 or any other chapter; (iii) other goods for disabled which are specified under List-30 covered under Chapter 90 or any other chapter. Thus, it would appear that the punctuation mark 'comma' in the exemption entry under Serial No. 578 of the Notification No. 50/2017 Customs (supra) and similarly for Serial No.257 of the Notification No. 01/....
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....10.2025 and thereby the goods are entitled to exemption benefit. Alternatively, imported goods being implants for severely physically handicapped patients, are equally covered by Entry E(9) of List 21 of Notification 45/2025-Cus dated 24.10.2025. Accordingly, they will be eligible for nil rate of BCD in terms of Sr No. 385 of Notification 45/2025-Cus dated 24.10.2025 5.11 It is submitted that on a perusal of description of the goods of Sr No. 385 and description of Entry No. E (9) of List 21, it is clear that the terms "disabled" and "severely physically handicapped patients" have not been defined in the Notification. The Notification also does not specify the duration of the physical disability or handicap i.e., whether temporary or permanent. Entry E (9) under List 21 merely requires that the imported implants be meant for severely physically handicapped patients. 5.12 It is a settled law that if the expressions or terms used in the act or Notification have not been defined under the said act or Notification, regard can be given to the natural and ordinary meaning of the said expression. To arrive at such a meaning, as per the rule of literal interpretation, one can poss....
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....at no distinction was made between the terms, 'disabled' and 'severely handicapped' patients. The Hon'ble CESTAT held that the subject goods being implants meant for joint replacement and spinal instruments for persons requiring such replacement, are clearly eligible for the exemption under SI. No. 373 read with List 41 of Notification No. 21/02-Cus., dated 01.03.2002 which covered "instruments and implants for severely physically handicapped patients and joint replacement and spinal instruments and implants including bone cement". This Notification was in existence prior to Notification No. 50/2017-Cus., dated 30.06.17. The relevant extract from the decision is reproduced below for ease of reference: 2. The appellants imported the impugned consignment "nkll ultra congruent tibial insert (Implants)". The same has been classified under Heading 90.21 but has been denied exempt on under Notification No. 21/2002. 3. We find that the said Notification No. 21/2002 as amended by Notification No. 66/2004 and as applicable at the relevant time exempts "assistive devices, rehabilitation aids and other goods for disabled, specified in List 41" under SI. N....
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....c daily mobility. 3 Mpact System (Hip Implant) This implant is used as total hip replacement to reconstruct the hip socket. Without these implants it is severely limited / impossible for human to perform basic function such as weight-bearing, walking, balance, and basic daily mobility. 4 Short Medacta Stem (SMS) (Femur (upper thigh bone) It is a bone-preserving short femoral stem used in total hip replacement. This implant replaces femoral component of the hip joint. Without these implants it is severely limited / impossible for human to perform basic function such as weight-bearing, walking, balance, and basic daily mobility. 5 M-Vizion Monobloc stem (Hip Implant) It is a femoral replacement stem used when the natural femur (upper portion of the thigh bone forming the hip joint) is damaged beyond repair. This implant replaces femoral component of the hip joint. Without it, standing, walking, and even transferring between sitting and standing become severely limited or impossible. 6 Medacta shoulder system (Shoulder Implant) It is a shoulder joint implant. It replaces the shoulder joint. Without this, pain-free arm elevation, lifting, rotation, o....
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.... Applicant's Understanding: Yes, the products shall be classifiable as under: Sr No. Product being imported Classification 1 GMK Sphere 90211000 "Orthopaedic or fracture appliances" / 90213100 "artificial joints" 2 AMIStem-P/ Quadra-P 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 3 Mpact System 90211000 "Orthopaedic or fracture appliances" / 90213100 "artificial joints" 4 Short Medacta Stem (SMS) 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 5 M-Vizion Monobloc stem 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 6 Medacta shoulder system 90211000 "Orthopaedic or fracture appliances"/ 90213100 "artificial joints" 7 Moto partial knee system 90211000 "Orthopaedic or fracture appliances" / 90213100 "artificial joints" 8 Mpact 3D Metal Two- hole 90211000 "Orthopaedic or fracture appliances" / 90213900 "Other" 9 Masterloc 90211000 "Orthopaedic or fracture appliances* / 90213900 "Other" b) Question 2: Whether the product in question i.e., knee implants, hip implants and shoulder implants are eligible for exemption benefit under ....
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....amaged joint with a metallic/polymeric prosthesis. They are not external appliances. The correct classification therefore appears to be as under: (a) Complete artificial joint - CTI 9021 31 00 - Artificial joints; (b) Individual components which are not themselves a joint or complete item - CTI 9021 39 00 - Other artificial parts of the body or CTI 90219090 - Others respectively; (c) The alternative plea under CTI 9021 10 00 merits rejection. The tariff structure and HSN Explanatory Notes which are a safe guide place artificial joints separately from orthopaedic appliances. The two therefore cannot be conflated. 8.2.3 Classification is required to be determined primarily in terms of Rule 1 of the General Rules for Interpretation of the Import Tariff, having regard to the terms of the headings and the relevant Section and Chapter Notes. The Applicant's attempt to claim alternate classification under CTI 9021 1000, 9021 3100 and 9021 3900 is, therefore, not acceptable, as classification cannot be kept open between multiple competing tariff items. 8.2.4 Where more than one heading or tariff item appears prima facie applicable, Rule 3(a) mandates th....
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....2017 and List 41 of Notification No. 21/2002 respectively). The ratio of both decisions turns entirely on these words. Those very words are no longer present in List 21 of Notification No. 45/2025-Cus. The decisions are, accordingly, distinguishable per incuriam to the present notification. 8.3.4 Goods do not fall under Entry B(1) to List 21 - they are not "orthopaedic appliances" a. Entry B(1) of List 21 covers "Orthopaedic appliances falling under heading No. 90.21". However, classification is required to be determined primarily in terms of Rule 1 of the General Rules for Interpretation of the Import Tariff, having regard to the terms of the headings and the relevant Section and Chapter Notes. The Applicant's attempt to bring the goods within the broader description of "orthopaedic appliances" is not acceptable where the goods are more specifically described under Heading 9021 as "artificial joints" or "other artificial parts of the body". Where more than one tariff description appears prima facie applicable, Rule 3(a) mandates that the most specific description shall be preferred over a more general description. Consequently, Entry B(1) of List 21 cannot be expan....
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....nstrated beyond ambiguity that either Entry B(1) or Entry E(9) covers the present goods. The benefit of doubt, if any, must therefore go to the Revenue. 8.5 Accordingly it was requested to: (a) Rule that the goods are classifiable under TI 9021 31 00 (complete artificial joint assemblies) or TI 9021 39 00 (other artificial parts / components), as the case may be; and reject the alternative plea under TI 9021 10 00; (b) Hold that the goods are NOT ELIGIBLE for exemption under Sr. No. 385 of Notification No. 45/2025-Customs dated 24.10.2025 read with List 21; (c) Pass such further orders as deemed fit and proper in the interest of revenue. 9. Details of Personal Hearing: A personal hearing in this matter was conducted on 29.05.2026 at 12:30 pm. Advocates represented the applicant in the instant case of classification of various Body implants Knee, Shoulder, Hip. They argued the classification in chapter 90, either 902110000 or 90213900 & eligibility of exemption under notification 45/2025, effective rate being NIL. They provided source literature on definition and quoted few case laws, pronounced by Hon'ble CESTAT, Mumbai and Chennai. ....
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....PLINTS 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." Further, the relevant extract of Heading 9021, from the Tariff is set out below: Headings / Sub-Headings / Tariff Item Tariff Description 9021 ORTHOPAEDIC APPLIANCES, INCLUDING CRUTCHES, SURGICAL BELTS AND TRUSSES; SPLINTS AND OTHER FRACTURE APPLIANCES; ARTIFICIAL PARTS OF THE BODY; HEARINGAIDS AND OTHER APPLIANCES WHICH ARE WORN OR CARRIED, OR IMPLANTED IN THE BODY, TO COMPENSATE FOR A DEFECT OR DISABILITY 90211000 - Orthopaedic or fracture appliances - Artificial teeth and dental fittings 90212100 -- Artificial teeth 90212900 -- Other - Other artificial parts of the body 90213100 -- Artificial joints 90213900 -- Other 902140 - Hearing aids, excluding parts and accessories **** 10.6 A plain reading of the above heading shows that it encompasses several distinct categories of products, namely: * Orthopaedic appliances; * Fracture appliances; * Artificial teeth and de....
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....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. ..... 10.8 From the above, it is evident that the HSN draws a clear distinction between orthopaedic appliances and artificial parts of the body. The orthopaedic appliances enumerated in Part (I), such as splints, braces, trusses, corsets, orthopaedic footwear, crutches and appliances for treating deformities or supporting body parts, are all intended to prevent or correct bodily deformities or to support or hold parts of the body following an illness, operation or injury. These appliances assist, stabilise or correct the functioning of an existing body part but do not replace it. In contrast, Part (III) specifically covers articles which "wholly or partially replace defective parts of the body" and expressly includes "artificial joints (e.g., for hips, knees)" within the cat....
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....general or residuary entry (HPL Chemicals Ltd. v. CCE, 2006 (197) ELT 324 (SC); CCE v. Wockhardt Life Sciences Ltd., 2012 (277) ELT 299 (SC)). Accordingly, goods specifically covered under Tariff Item 90213100 or 90213900 cannot be classified under Tariff Item 90211000 or the residuary Tariff Item 90219090 merely because they are used in orthopaedic surgery or in the treatment of orthopaedic conditions. 10.11 Chapter Note 6 to Chapter 90 defines the expression "orthopaedic appliances" as follows: 6. For the purpose of heading 9021, the expression -orthopaedic appliances means appliances for: (i) preventing or correcting bodily deformities; or (ii) supporting or holding parts of the body following an illness, operation or injury. Orthopaedic appliances include footwear and special insoles designed to correct orthopaedic conditions, provided that they are either (1) made to measure, or (2) mass produced, presented singly and not in pairs and designed to fit either foot equally. The HSN Explanatory Notes further illustrate orthopaedic appliances by reference to products such as appliances for hip diseases, humerus splints, jaw appliances, trac....
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....implantable components such as femoral stems, acetabular cups, liners, heads and similar prosthetic components, although designed for incorporation into artificial joint systems, do not by themselves constitute complete artificial joints at the time of importation. Nevertheless, upon implantation they become permanent artificial replacements for parts of the human body. Such goods are therefore appropriately classifiable under tariff item 90213900 as "Other artificial parts of the body." 10.15A The applicant has further contended that individual components such as femoral stems, acetabular cups, liners, femoral heads and similar prosthetic parts are specifically designed for use in artificial joint systems and should therefore be classified in the same manner as complete artificial joints. The contention cannot be accepted. Classification is required to be determined according to the condition of the goods as presented for importation. The individual components under consideration do not themselves constitute complete artificial joints at the time of importation. While they are designed for incorporation into joint replacement systems, they remain separate prosthetic components ....
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....as a complete prosthetic assembly comprising the interacting femoral, tibial and bearing components necessary to perform the articulating function of the replaced compartment, the product constitutes an artificial joint for tariff purposes and is appropriately classifiable under tariff item 90213100. However, where individual components of such system are imported separately, their classification would fall for determination according to their individual character and condition as imported. 10.22 The products marketed as P Family Stems, SMS Stem, M-Vizion Monobloc Stem and Masterloc are implantable femoral stem components intended for insertion into the femur as part of a hip replacement procedure. These products do not by themselves constitute complete artificial joints but are prosthetic components forming part of a joint replacement system. Accordingly, they are classifiable under tariff item 90213900 as "Other artificial parts of the body". 10.23 Similarly, the Mpact 3D Acetabular System, including acetabular shells, cups, liners and analogous acetabular components, represents implantable prosthetic parts designed to replace the acetabular portion of the hip anatomy. Such....
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....d 24.10.2025 reads as under: Sr No. Chapter or Heading or sub-heading or tariff item Description of goods Standard rate IGST Condition No. 385 90 or any other Chapter Assistive devices, rehabilitation aids and other goods for disabled, specified in List 21. Nil 10.28 Further, the relevant portion of List 21 as referred in Sr No. 385 of Notification 45/2025-Cus dated 24.10.2025 reads as under: A. (1) Braille writers and braille writing instruments ................ ................ B. (1) Orthopaedic appliances falling under heading No. 90.21 of the First Schedule (2) Wheel chairs falling under heading No. 87.13 of the First Schedule C. Artificial electronic larynx and spares thereof D. Artificial electronic ear (Cochlear implant) E. (1) Talking books (in the form of cassettes, discs or other sound reproductions) and large-print books, braille embossers, talking calculators, talking thermometers ..................... ..................... (9) Implants for severely physically handicapped patients including bone cement "Assistive devices, rehabilitation aids and other goods....
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....lly or partially replace defective anatomical structures and perform their physiological function. Accordingly, the Customs Tariff and the HSN Explanatory Notes clearly recognize orthopaedic appliances on the one hand and artificial joints/artificial parts of the body on the other as separate and distinct classes of goods. 10.32 In the present case, it has already been held while determining the classification issue that the subject goods are not classifiable under tariff item 90211000 as orthopaedic appliances. Complete knee, hip and shoulder replacement systems, being complete prosthetic joint assemblies intended to replace natural joints, are appropriately classifiable under tariff item 90213100 as "Artificial joints". Individual implantable prosthetic components such as femoral stems, acetabular cups, liners, heads and similar components, which do not constitute complete artificial joints at the time of importation, are appropriately classifiable under tariff item 90213900 as "Other artificial parts of the body". The essential function of the subject goods is not to support, stabilize, hold or correct an existing anatomical structure. Rather, they are implanted as perm....
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....Artificial joints" and "Other artificial parts of the body" would become redundant. A tariff entry must be interpreted in a manner that gives effect to all constituent parts of the heading and avoids rendering any specific entry otiose. Since the tariff specifically provides separate classifications for artificial joints and other artificial parts of the body, such goods must be classified in their respective specific entries and cannot be absorbed into the broader category of orthopaedic appliances merely because they alleviate disability. 10.34 The applicant has further contended that, since the subject goods are implanted by orthopaedic surgeons and are used in the treatment of orthopaedic disorders, they should be regarded as orthopaedic appliances. The contention cannot be accepted. Classification under the Customs Tariff, and consequently eligibility under an exemption notification, is determined by the objective characteristics, nature and function of the goods and not by the branch of medicine in which they are used or the medical specialization of the practitioner who implants them. The mere fact that a product is used in orthopaedic surgery does not, by itself, rend....
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....e referred to "all goods of Heading 9021" or "goods falling under Heading 90.21". Instead, the legislature has consciously employed the narrower expression "orthopaedic appliances". The expression used in the notification must be given its ordinary meaning and cannot be expanded so as to encompass goods which are specifically classifiable as artificial joints or other artificial parts of the body. 10.37 It is a settled principle that exemption notifications are required to be construed strictly, and the burden lies upon the claimant to establish that the goods fall squarely within the terms of the exemption. An exemption entry cannot be enlarged by implication or by an interpretation that renders any part of the statutory language redundant. Since the subject goods are classifiable as "Artificial joints" under tariff item 90213100 or as "Other artificial parts of the body" under tariff item 90213900, and not as "Orthopaedic appliances" under tariff item 90211000, they do not satisfy the description prescribed in Entry B(1) of List 21. Accordingly, the subject goods are not ineligible for exemption under Entry B(1) of List 21 appended to Notification No. 45/2025-Custo....
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....ld continue to receive exemption notwithstanding the deliberate omission of the very words which expressly covered them under the earlier notifications. Such an interpretation would render the amendment otiose and defeat the manifest legislative intent underlying the change in language. 10.41 Consequently, the decisions in Smith & Nephew Healthcare Pvt. Ltd. and Centerpulse India do not advance the applicant's case. In those cases, the exemption entries specifically contained an independent limb extending the benefit to joint replacement implants. It was in that statutory context that exemption was held to be available. The ratio of those decisions cannot be mechanically applied to the present notification after the legislature has consciously removed the language relating to joint replacement implants. The said decisions are therefore distinguishable both on facts and on law. 10.42 The applicant has further argued that the expressions "disabled" and "severely physically handicapped" are not defined in the notification and should therefore receive a broad interpretation. It has also been contended that patients suffering from severe arthritis, degenerative joint ....
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....dicap, rather than to all persons who may experience pain, reduced mobility or functional limitation arising from orthopaedic conditions. Joint replacement procedures are routinely undertaken for a broad spectrum of patients, including those suffering from age-related degeneration, osteoarthritis, rheumatoid arthritis, traumatic injury and revision requirements. The degree of impairment among such patients may vary considerably depending upon the nature and progression of the underlying condition. Consequently, it cannot be presumed that every recipient of a knee, hip or shoulder implant falls within the category of a severely physically handicapped patient merely because the implant is used in the treatment of an orthopaedic condition. In the absence of any material demonstrating that the subject goods are specially intended for, or principally used by, the specific class of severely physically handicapped patients contemplated by Entry E(9), the benefit of the exemption cannot be extended on the basis of a general association with orthopaedic treatment. 10.44 The applicant has also contended that, in the absence of the implants, the patient may become severely disabled o....
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...., relevant Chapter Notes and the HSN Explanatory Notes, which constitute a safe guide for interpreting tariff entries; (ii) Heading 9021 and the HSN Explanatory Notes draw a clear distinction between "orthopaedic appliances" and "artificial parts of the body", including "artificial joints", treating them as separate and distinct categories of goods; (iii) Orthopaedic appliances are intended to prevent or correct bodily deformities or to support or hold existing body parts following illness, operation or injury, whereas artificial joints and other artificial parts of the body are implantable prosthetic devices designed to wholly or partially replace defective anatomical structures and perform their physiological function; (iv) Consequently, complete knee, hip and shoulder replacement systems, namely GMK, Sphere, SpheriKA, Mpact System, Medacta Shoulder System and Moto Partial Knee System, when imported as complete prosthetic joint assemblies, are classifiable under CTI 90213100 as "Artificial joints"; (v) Implantable prosthetic components such as P Family Stems, SMS Stem, M-Vizion Monobloc Stem, Masterloc, acetabular shells, cups, liners, femoral ....
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....eration and other orthopaedic conditions, who may exhibit varying degrees of impairment. The applicant has not established that the goods are specifically designed, exclusively intended or principally used for the narrower and identifiable class of "severely physically handicapped patients" contemplated under Entry E(9) of List 21; and (xii) In view of the Constitution Bench judgment in Commissioner of Customs (Import), Mumbai v. Dilip Kumar & Co., (2018) 9 SCC 1, exemption notifications are required to be construed strictly and the burden lies upon the claimant to establish that the goods fall squarely within the exemption entry; and (xiii) Accordingly, the subject goods are classifiable under CTI 90213100 or CTI 90213900, as the case may be, do not answer the description of "Orthopaedic appliances" under Entry B(1), are not covered by Entry E(9) of List 21, and are therefore not eligible for exemption under Sr. No. 385 of Notification No. 45/2025-Customs dated 24.10.2025. 11. In view of the facts and circumstances of the case and the foregoing discussion and findings, I conclude that: (a) The subject goods named and marketed as GMK, Sphere and Spheri....