Parts and accessories of hearing aids

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 90 10 (Parts and accessories of 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). Import requires compliance with all conditions, including CDSCO registration, specified in that notification before a bill of entry can be out-of-charged.

What this is

HSN code

9021 90 10

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
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 parts and accessories under the Medical Devices Rules, 2017 prior to filing the bill of entry. The registration must cover the specific device category and must be current; unregistered medical devices are liable to seizure and confiscation at the port of import.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Verify and comply with all conditions of G.S.R. 102(E) dated 11-02-2020 before the consignment arrives at the Indian port. Upload the CDSCO registration certificate and any other documents mandated by the notification in e-Sanchit at the bill of entry stage.
G.S.R. 102(E) dated 11-02-2020 · CDSCO import conditions under Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is importing hearing-aid parts and accessories under the assumption that components and accessories attract a lighter compliance burden than the finished hearing aid itself. G.S.R. 102(E) dated 11-02-2020 brings parts and accessories within the same CDSCO registration requirement as the finished device; a consignment arriving without a current, category-specific registration is subject to detention, demurrage, and confiscation regardless of the end-use intended by the importer.

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Frequently asked

Does HSN 9021 90 10 require BIS certification?

No, no BIS Quality Control Order covers parts and accessories of hearing aids. 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.

Does the CDSCO registration requirement apply to parts and accessories, or only to finished hearing aids?

G.S.R. 102(E) dated 11-02-2020 explicitly covers parts and accessories of hearing aids; registration with CDSCO is mandatory before import, and the registration must be specific to the device category being imported.

What happens if a consignment of hearing-aid accessories arrives without a valid CDSCO registration?

Customs will not grant out-of-charge; the consignment faces detention, accumulating demurrage and ground rent, and is liable to seizure and confiscation under the Medical Devices Rules, 2017 for non-compliance with G.S.R. 102(E) dated 11-02-2020.

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