Case Law Details
In re Medacta India Pvt. Ltd. (CAAR Mumbai)
The Customs Authority for Advance Rulings (CAAR), Mumbai, considered an application seeking an advance ruling on the customs classification of various imported knee, hip, and shoulder implants and their eligibility for exemption under Serial No. 385 of Notification No. 45/2025-Customs dated 24 October 2025.
The applicant proposed to import multiple models of knee implants, hip implants, and shoulder implants under different brand names. The application described these products, their components, intended medical use, and the body parts they replace. It also stated that the implants would be imported under the required medical device licence and supplied to registered hospitals and surgical centres for use by orthopaedic surgeons.
The applicant sought rulings on two issues:
- Whether the products should be classified under Heading 9021 as “artificial joints,” “orthopaedic appliances,” or another category under the Customs Tariff.
- Whether the products qualified for exemption under Serial No. 385 of Notification No. 45/2025-Customs dated 24 October 2025.
In support of its application, the applicant referred to the General Rules for Interpretation, Heading 9021 of the Customs Tariff, HSN Explanatory Notes, Chapter Note 6 to Chapter 90, dictionary meanings, and judicial decisions. It submitted that the implants replace damaged body parts and should be regarded as artificial parts of the body. According to the applicant, certain products constituted artificial joints while others were classifiable as other artificial parts of the body. Alternatively, it contended that the products could also be regarded as orthopaedic appliances under tariff item 90211000.
The applicant further argued that the imported implants were eligible for exemption under Serial No. 385 because List 21 to the notification included orthopaedic appliances under Heading 9021 and also covered implants for severely physically handicapped patients. It referred to earlier decisions to support its submissions and also relied upon dictionary meanings of terms such as “deformity,” “disabled,” and “handicap.” The application explained that the implants are permanently fitted in patients and restore mobility and bodily functions by replacing damaged joints or body parts.
After examining the tariff provisions, HSN Explanatory Notes, Chapter Notes, the notification, the submissions made, and the product descriptions, the Authority distinguished between complete prosthetic joint assemblies and implantable prosthetic components.
The Authority held that complete prosthetic joint assemblies imported as knee replacement systems, hip replacement systems, shoulder replacement systems, and partial knee replacement systems perform the articulating function of natural joints. These products were held to be classifiable under tariff item 90213100 as “Artificial joints.”
The Authority further held that implantable femoral stem components and other implantable prosthetic components, including acetabular systems, shells, cups, liners, femoral heads, and similar products which do not themselves constitute complete artificial joints at the time of importation, are classifiable under tariff item 90213900 as “Other artificial parts of the body.”
On the exemption issue, the Authority concluded that products classifiable as “Artificial joints” under tariff item 90213100 and “Other artificial parts of the body” under tariff item 90213900 do not satisfy the description of “Orthopaedic appliances” specified in Entry B(1) of List 21 appended to Notification No. 45/2025-Customs dated 24 October 2025.
The Authority also held that the imported goods are not covered by Entry E(9) of List 21 relating to “Implants for severely physically handicapped patients including bone cement.” Accordingly, the goods were held to be ineligible for exemption under that entry as well.
Accordingly, the CAAR ruled that:
- Complete prosthetic joint assemblies are classifiable under tariff item 90213100 as “Artificial joints.”
- Implantable prosthetic components that do not constitute complete artificial joints at the time of import are classifiable under tariff item 90213900 as “Other artificial parts of the body.”
- The imported goods are not eligible for exemption under Serial No. 385 of Notification No. 45/2025-Customs dated 24 October 2025.
FAQs
Q.1 What questions were raised before the Customs Authority for Advance Rulings?
Ans. The application sought rulings on the customs classification of knee, hip and shoulder implants and whether they qualified for exemption under Serial No. 385 of Notification No. 45/2025-Customs.
Q.2 How were complete prosthetic joint assemblies classified?
Ans. The Authority classified complete prosthetic joint assemblies under tariff item 90213100 as “Artificial joints.”
Q.3 How were implantable prosthetic components that are not complete artificial joints classified?
Ans. They were classified under tariff item 90213900 as “Other artificial parts of the body.”
Q.4 Did the Authority allow exemption under Serial No. 385 of Notification No. 45/2025-Customs?
Ans. No. The Authority held that the imported goods were not eligible for exemption under Serial No. 385.
Q.5 Why was the exemption denied?
Ans. The Authority held that the goods did not satisfy the description of “Orthopaedic appliances” under Entry B(1) of List 21 and were also not covered by Entry E(9) of List 21.
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