Stethoscopes

Stethoscopes for medical diagnosis

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 12 (Stethoscopes) 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 without a valid CDSCO registration certificate is not permitted at the bill-of-entry stage, and the importation of old or refurbished stethoscopes is governed by CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024.

What this is

HSN code

9018 90 12

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · Medical Devices Rules, 2017 read with G.S.R. 102(E) dated 11-02-2020

Customs documentation

Registration certificate from CDSCO
MOHFW G.S.R. 102(E) compliance declaration
Import permit from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain a valid CDSCO registration certificate for stethoscopes as a listed medical device under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must be current; consignments imported without a valid registration are liable to detention and confiscation under the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017 · MOHFW notification
2
If importing stethoscopes in an old or refurbished state, confirm the device falls within the list of equipment permitted in such condition under CBIC Instruction 08/2024-Customs dated 05-04-2024, as amended by Instruction 25/2024-Customs dated 28-10-2024. Consignments not appearing on the permitted list are barred from import in refurbished condition.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024

A word of counsel

The most common error on this tariff line is presenting a CDSCO registration that covers only specific models or the foreign manufacturer's principal product line, while the consignment contains a variant or sub-model not explicitly listed on the certificate. CDSCO registration in India is device-specific, and a certificate covering one model does not extend by implication to a related model; an undisclosed variant arriving at the port faces detention and referral back to CDSCO for a separate registration before out-of-charge can be granted.

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Frequently asked

Does HSN 9018 90 12 require BIS certification?

No, stethoscopes 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.

Can refurbished or second-hand stethoscopes be imported under this HSN?

Only if the specific device appears on the permitted list of old or refurbished equipment under CBIC Instruction 08/2024-Customs dated 05-04-2024 as updated by Instruction 25/2024-Customs dated 28-10-2024; devices not on that list are barred from import in refurbished condition.

Does CDSCO registration need to be in the importer's name, or can the foreign manufacturer hold it?

Under the Medical Devices Rules, 2017, the registration certificate for an imported device is granted to the Indian importer or their authorised representative; a certificate held solely by the foreign manufacturer without a valid Indian registration does not satisfy the G.S.R. 102(E) condition at the bill of entry.

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