Orthopeaedic or fracture appliances

Orthopaedic appliances, splints and fracture appliances

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9021 10 00 (Orthopaedic or fracture appliances) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import of used or refurbished high-end, high-value units is additionally restricted under an Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023.

What this is

HSN code

9021 10 00

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020 (Medical Devices Rules, 2017)

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Compliance declaration from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Obtain CDSCO registration for the orthopaedic or fracture appliance under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must cover the specific device category and be held by the authorised Indian importer; devices without current CDSCO registration are detained at the port of import.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
For used or refurbished high-end, high-value orthopaedic equipment, verify eligibility against the restricted-import conditions in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023 before placing the purchase order. Critical-care medical equipment is treated under a separate sub-regime; confirm the applicable classification with DGHS before shipment.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is importing used or refurbished orthopaedic equipment without first confirming whether the unit qualifies as 'critical care' or 'high-end, high-value' under the MEFCC Office Memorandum — the two sub-categories carry materially different restriction levels. A consignment cleared under the wrong sub-category attracts detention, mandatory re-export, and potential confiscation; the CDSCO registration alone does not satisfy the MEFCC condition for restricted used equipment.

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Frequently asked

Does HSN 9021 10 00 require BIS certification?

No, orthopaedic and fracture appliances are not covered by a BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under G.S.R. 102(E) dated 11-02-2020, with a concurrent restricted-import overlay for used or refurbished high-end, high-value units under the Ministry of Environment, Forest and Climate Change.

Does the CDSCO registration requirement apply to all orthopaedic appliances under this tariff line?

CDSCO registration applies to devices listed in G.S.R. 102(E) dated 11-02-2020; importers should verify whether the specific appliance — splint, brace, fracture device, or surgical belt — appears in that notification's schedule before assuming the device is unregulated.

What restrictions apply to importing used or refurbished orthopaedic equipment?

Import of high-end, high-value used or refurbished medical equipment that is not classified as critical care is restricted under the MEFCC Office Memorandum dated 15-12-2023, subject to conditions recommended by the Directorate General of Health Services; non-compliance exposes the consignment to seizure or compulsory re-export.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / MOHFW / MEFCC / Indian Customs CUSDATA.