Other

Other implantable or worn medical devices compensating defect or disability

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 39 00 covers medical devices listed under G.S.R. 102(E) dated 11-02-2020, issued by the Ministry of Health and Family Welfare (MOHFW), and is subject to registration with the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. Mandatory document uploads in e-Sanchit — including a Certificate of Analysis, Batch Release Certificate, and consignment label — are required before customs out-of-charge.

What this is

HSN code

9021 39 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 manufacturer
Certificate of Analysis from manufacturer

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Confirm that the medical device falls within the scope of G.S.R. 102(E) dated 11-02-2020 and that a valid CDSCO registration is in place for the device. Import of devices listed in that notification without CDSCO registration is not permitted under the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · 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 CCR requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is uploading only the CDSCO registration certificate while omitting the Batch Release Certificate (0030dc) or the consignment label (0110dc) — each is independently mandatory and a missing upload triggers detention pending re-submission in e-Sanchit. Because this is a residual '9021 39 00' entry, importers should also verify at the time of purchase order whether the specific device was notified under G.S.R. 102(E) and whether a separate import licence condition applies; devices added to the notified list after the purchase order is placed remain subject to the full CDSCO registration requirement.

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Frequently asked

Does HSN 9021 39 00 require BIS certification?

No, no BIS Quality Control Order covers this product family. 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 document codes must be uploaded in e-Sanchit for this tariff line?

Three documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all must be uploaded before the proper officer grants out-of-charge.

Does G.S.R. 102(E) cover all medical devices under HSN 9021 39 00?

No. G.S.R. 102(E) dated 11-02-2020 notifies specific device categories; devices falling under the residual HSN that are not listed in that notification may be subject to different or transitional CDSCO requirements, and the importer should verify scope directly with CDSCO before shipment.

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