Other

Hearing aids, other than parts and accessories

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 40 90 (Other hearing aids) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Registration with CDSCO is a mandatory pre-import condition, and consignments without a valid device registration are liable to detention at the bill-of-entry stage.

What this is

HSN code

9021 40 90

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

Device registration certificate from CDSCO
Import licence from CDSCO
MOHFW notification compliance declaration

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 hearing aid under the Medical Devices Rules, 2017, confirming the device is listed within the scope of G.S.R. 102(E) dated 11-02-2020. The registration certificate must be valid and in the name of the Indian authorised representative or importer before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Upload all mandatory CDSCO registration and import-licence documents in e-Sanchit prior to the bill of entry. Customs out-of-charge will not be granted until the proper officer confirms that the device registration and associated compliance documentation under G.S.R. 102(E) have been uploaded.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is importing under a registration obtained for a related hearing-aid model and assuming it covers variant configurations classified as 'Other' under 9021 40 90. CDSCO registration is device-specific; each model or configuration requires its own registration, and a mismatch between the registered device description and the imported product description results in consignment detention pending regularisation, with demurrage accruing throughout.

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Frequently asked

Does HSN 9021 40 90 require BIS certification?

No, hearing aids classified under this tariff line 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.

Is a separate CDSCO import licence required in addition to device registration?

Yes. The conditions specified in G.S.R. 102(E) dated 11-02-2020 require both device registration and compliance with all attendant licensing conditions under the Medical Devices Rules, 2017; registration alone does not constitute authorisation to import.

What happens if the CDSCO registration expires before the consignment arrives?

An expired registration renders the import non-compliant at the bill-of-entry stage, exposing the consignment to detention and potential seizure under the Drugs and Cosmetics Act, 1940; renewal must be secured and the updated certificate uploaded in e-Sanchit before the vessel arrives.

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