ENT precision instruments

ENT precision instruments for medical use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 42 (ENT precision instruments) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare (MOHFW) under G.S.R. 102(E) dated 11-02-2020. Import is conditional on compliance with the registration and licensing requirements specified in that notification. Separate CBIC Instruction conditions apply to the import of old or refurbished equipment under this tariff line.

What this is

HSN code

9018 90 42

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 ENT precision instruments prior to import, in compliance with the conditions specified in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. The registration must cover the specific device category and must be current and valid at the time of filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
If importing ENT precision instruments in old or refurbished condition, verify that the specific equipment falls within the permitted list issued under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Equipment not on the permitted list is not eligible for import in refurbished or used condition and will be detained at the port of entry.
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 importing old or refurbished ENT instruments without verifying the permitted-equipment list under CBIC Instructions 08/2024-Customs and 25/2024-Customs. CDSCO registration is a necessary but not sufficient condition for such imports — the instrument must also appear on the approved refurbished-equipment list, and a consignment that satisfies the CDSCO registration requirement but fails the refurbished-equipment gate will be detained and is liable to re-export or confiscation.

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Frequently asked

Does HSN 9018 90 42 require BIS certification?

No, no BIS Quality Control Order covers ENT precision instruments under this tariff line. 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.

Are all ENT precision instruments eligible for import in refurbished or old condition?

No. Only equipment specifically listed in the annexures to CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024 may be imported in old or refurbished state; instruments outside those lists are restricted to new condition only.

What happens if CDSCO registration has not been obtained before the consignment arrives at the Indian port?

A consignment of medical devices arriving without a valid CDSCO registration is liable to detention at the port of entry, with demurrage and ground rent accruing until either registration is regularised or the consignment is re-exported.

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