Other

Other orthopaedic appliances and fracture devices

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 29 00 (Other orthopaedic appliances) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, for medical devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must ensure CDSCO registration and upload mandatory documents in e-Sanchit before out-of-charge at the bill-of-entry stage.

What this is

HSN code

9021 29 00

Chapter

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

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Batch release certificate from CDSCO
Label of consignment from importer

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify that the orthopaedic appliance or fracture device falls within the medical devices listed in G.S.R. 102(E) dated 11-02-2020 issued by MOHFW, and obtain the requisite CDSCO registration before shipment. Import without a valid CDSCO registration renders the consignment liable to detention and seizure under the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020 (MOHFW) · Medical Devices Rules, 2017
2
Upload the mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The proper officer will verify these uploads before granting out-of-charge.
CDSCO PGA facilitation requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is assuming that all orthopaedic appliances under HSN 9021 29 00 require CDSCO registration — the obligation is triggered only for devices specifically listed in G.S.R. 102(E) dated 11-02-2020. Importers of products outside that scheduled list must nonetheless ensure that the bill of entry is not presented without the requisite uploaded documents, because PGA-facilitated bills not routed through CDSCO for NOC are subject to spot verification by the proper officer, and a missing upload causes out-of-charge denial and consequential demurrage.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 9021 29 00 require BIS certification?

No, orthopaedic appliances and fracture devices under this tariff line are not subject to any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, for devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Which documents must be uploaded in e-Sanchit for clearance of this HSN?

Three documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc). All three must be uploaded in e-Sanchit before the bill of entry is presented, as the proper officer verifies these prior to out-of-charge.

Does every orthopaedic appliance under HSN 9021 29 00 require CDSCO registration?

No — the CDSCO registration requirement applies only to medical devices specifically listed in G.S.R. 102(E) dated 11-02-2020 issued by MOHFW. Products falling outside that scheduled list are not subject to the same registration conditions, though e-Sanchit document compliance remains applicable.

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