Baby incubators

Baby incubators for neonatal medical use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 92 (Baby incubators) is subject to Central Drugs Standard Control Organisation (CDSCO) registration as a medical device under G.S.R. 102(E) dated 11-02-2020, issued by the Ministry of Health and Family Welfare (MOHFW). Import is conditional on compliance with all registration and licensing requirements specified in that notification, and separate CBIC instructions govern the conditions under which old or refurbished incubators may be imported.

What this is

HSN code

9018 90 92

Chapter

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

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Refurbished-equipment clearance from CBIC

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 baby incubator as a listed medical device under G.S.R. 102(E) dated 11-02-2020. The registration — covering manufacturer, device class, and model — must be current and valid at the date the bill of entry is filed; consignments from unregistered manufacturers or for unregistered models are liable to detention and confiscation.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules
2
If the consignment comprises old or refurbished baby incubators, verify that the specific equipment falls within the category permitted for import in that condition per CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical devices not listed in the permitted-equipment schedule attracts outright refusal of out-of-charge.
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 a brand-new model variant — including an upgraded version of a previously registered incubator — without first confirming that the specific model-device combination holds a separate CDSCO registration. CDSCO registration is device-model-specific and manufacturer-specific; a registration for a related product or an older model does not extend to a newer variant, and customs out-of-charge will be withheld until the correct registration certificate is produced.

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Frequently asked

Does HSN 9018 90 92 require BIS certification?

No. Baby incubators are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, with CDSCO registration as the binding clearance requirement.

Can refurbished baby incubators be imported under this HSN?

Only if the specific equipment type appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024; refurbished devices not on that list are barred from import regardless of CDSCO registration status.

What happens if the CDSCO registration has expired at the time of import?

An expired registration is treated as no registration: customs will withhold out-of-charge, and the consignment faces detention and ground rent accumulation until a valid registration is produced or the goods are re-exported.

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