Frequency modulated hearing aid system used for hearing by handicapped persons in group situation

FM hearing aid systems for group hearing situations

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 40 10 (Frequency modulated hearing aid system for group situations) 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 requires compliance with all conditions, including CDSCO registration, specified in that notification.

What this is

HSN code

9021 40 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 FM hearing aid system as a listed medical device under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must cover the specific device and its manufacturer, and must be current at the time of import.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Ensure all conditions prescribed in G.S.R. 102(E) dated 11-02-2020 are satisfied at the bill of entry stage and that the requisite CDSCO registration documentation is uploaded in e-Sanchit prior to out-of-charge. Non-compliance renders the consignment liable to detention and seizure under the Drugs and Cosmetics Act, 1940.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

A word of counsel

The most common error on this tariff line is conflating device registration with import licence issuance — CDSCO registration under G.S.R. 102(E) is a prerequisite, but the importer must separately ensure that the foreign manufacturer is authorised and that an Authorised Indian Representative has been designated where required under the Medical Devices Rules, 2017. A consignment cleared without a valid, in-scope CDSCO registration is subject to seizure and the importer faces criminal liability under the Drugs and Cosmetics Act, 1940.

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Frequently asked

Does HSN 9021 40 10 require BIS certification?

No, FM hearing aid systems are not within the BIS Quality Control Order regime. 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 specific regulatory instrument lists this device and what conditions apply?

G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare lists this device and mandates CDSCO registration along with all other conditions specified therein as prerequisites to import.

Does the CDSCO registration requirement apply to both new and existing importers of FM hearing aid systems?

Yes. G.S.R. 102(E) dated 11-02-2020 applies to all importers of listed medical devices; there is no grandfather exemption, and any consignment imported without a valid in-scope CDSCO registration is non-compliant regardless of prior import history.

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