Defibrillators

Defibrillators, electromedical cardiac resuscitation devices

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 94 (Defibrillators) 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) vide G.S.R. 102(E) dated 11-02-2020. Import is conditional on the device and its manufacturer holding valid CDSCO registration before the bill of entry is filed.

What this is

HSN code

9018 90 94

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 G.S.R. 102(E) 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 defibrillator as a medical device listed under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. Both the device and the foreign manufacturer must be registered with CDSCO before the bill of entry is filed; unregistered devices are liable to detention and refusal of out-of-charge.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
Where the defibrillator is imported in an old or refurbished condition, confirm the specific model and equipment type appear 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 assuming that a valid CDSCO import licence for a new-condition defibrillator also covers a refurbished or second-hand unit of the same model. Old and refurbished electromedical equipment requires separate verification against the CBIC-notified permitted-equipment list; a device absent from that list cannot lawfully be imported regardless of its CDSCO registration status, and a consignment found non-compliant on this point faces confiscation rather than mere detention.

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Frequently asked

Does HSN 9018 90 94 require BIS certification?

No, defibrillators 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 mandated by the Ministry of Health and Family Welfare vide G.S.R. 102(E) dated 11-02-2020.

Can a refurbished defibrillator be imported under this HSN?

Only if the specific model appears on the permitted list of old or refurbished equipment notified under CBIC Instruction 08/2024-Customs dated 05-04-2024, as updated by CBIC Instruction 25/2024-Customs dated 28-10-2024; models absent from that list may not be imported in used condition.

Which conditions under G.S.R. 102(E) must an importer satisfy before shipment?

The importer must ensure valid CDSCO registration for both the device and the foreign manufacturing facility, and compliance with all conditions specified in G.S.R. 102(E) dated 11-02-2020, including any labelling and post-market surveillance requirements prescribed therein.

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