Artificial joints

Artificial joints for orthopaedic implantation

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 31 00 (Artificial joints) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a listed medical device under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is conditional on CDSCO registration and full compliance with the conditions notified in G.S.R. 102(E), including mandatory document upload in e-Sanchit before customs out-of-charge.

What this is

HSN code

9021 31 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
Certificate of analysis from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for the artificial joint product under the Medical Devices Rules, 2017, in compliance with the conditions specified in G.S.R. 102(E) dated 11-02-2020. An importer or Authorised Indian Representative acting on behalf of a foreign manufacturer must hold a valid registration before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit before filing the bill of entry. The proper officer will verify these mandatory uploads prior to granting out-of-charge.
CDSCO e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most frequent error on this tariff line is presenting a CDSCO registration that covers the device class but does not name the specific model or variant being imported — customs officers treating artificial joints as a single product family will examine the registration certificate against the device description on the commercial invoice. A model-level mismatch between the CDSCO registration and the shipment documentation results in consignment detention and demurrage pending regularisation, and no retroactive amendment to the registration is available at the port.

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 31 00 require BIS certification?

No, artificial joints are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to 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 artificial joints at the bill of entry?

Three documents are mandatory: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc); all must be uploaded before customs out-of-charge is granted.

Does the CDSCO registration requirement apply to both new and established foreign manufacturers?

Yes. G.S.R. 102(E) dated 11-02-2020 requires CDSCO registration and compliance with its stated conditions for all imports of listed medical devices, including artificial joints, regardless of whether the foreign manufacturer was previously supplying the Indian market.

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