Heart-lung machines

Heart-lung machines for cardiac surgery

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 93 (Heart-lung machines) 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) via G.S.R. 102(E) dated 11-02-2020. Importers must ensure the device is registered with CDSCO and that all conditions specified in G.S.R. 102(E) are met before filing the bill of entry. Import of old or refurbished heart-lung machines is additionally 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 93

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
Refurbished-equipment approval 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 heart-lung machine under the Medical Devices Rules, 2017, as mandated by G.S.R. 102(E) dated 11-02-2020. The registration certificate must be current and uploaded in e-Sanchit at the bill of entry; consignments without a valid CDSCO registration are liable to detention and refusal of out-of-charge.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
If the heart-lung machine is old or refurbished, verify that the specific equipment model appears on the permitted list issued under CBIC Instruction 08/2024-Customs dated 05-04-2024 and updated by CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of old or refurbished medical equipment not on that list is not permitted.
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 refurbished or second-hand heart-lung machine under the assumption that a valid CDSCO registration for the new equivalent device is sufficient. The old/refurbished equipment regime under CBIC Instructions 08/2024-Customs and 25/2024-Customs operates as an independent gate: the equipment type must appear on the permitted list regardless of CDSCO registration status, and a consignment that clears CDSCO review but falls outside the permitted-equipment list faces confiscation at the port of import.

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Frequently asked

Does HSN 9018 90 93 require BIS certification?

No, heart-lung machines 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, as notified by the Ministry of Health and Family Welfare via G.S.R. 102(E) dated 11-02-2020.

Which conditions under G.S.R. 102(E) must an importer satisfy at the bill of entry?

The importer must hold a valid CDSCO registration for the device and comply with all conditions specified in G.S.R. 102(E) dated 11-02-2020, including registration of the foreign manufacturer where applicable under the Medical Devices Rules, 2017.

Can a hospital import a refurbished heart-lung machine directly?

Only if the specific equipment is listed in the permitted old/refurbished equipment schedule under CBIC Instruction 08/2024-Customs dated 05-04-2024, as updated by CBIC Instruction 25/2024-Customs dated 28-10-2024; equipment not on that list cannot be imported in refurbished condition regardless of intended end-use.

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