Laproscopes

Laparoscopes, surgical visualisation instruments

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9018 90 96 (Laparoscopes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, read with G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import of used or refurbished high-end laparoscopes is additionally restricted under conditions notified by the Ministry of Environment, Forest and Climate Change (MEFCC) vide O.M. dated 15-12-2023, with CBIC Instructions 08/2024-Customs and 25/2024-Customs governing the permitted equipment list.

What this is

HSN code

9018 90 96

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
Import licence from CDSCO
Compliance declaration from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Obtain CDSCO registration for the laparoscope under the Medical Devices Rules, 2017, as mandated by G.S.R. 102(E) dated 11-02-2020. The registration certificate and any applicable import licence must be uploaded in e-Sanchit before the bill of entry is filed; customs out-of-charge will not be granted without verified CDSCO registration.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
If importing used or refurbished laparoscopes, confirm the specific equipment model appears on the permitted list notified under CBIC Instruction 08/2024-Customs dated 05-04-2024 and updated by Instruction 25/2024-Customs dated 28-10-2024. High-end, high-value used medical equipment not on the permitted list is Restricted and subject to the conditions in the MEFCC O.M. dated 15-12-2023; non-compliance renders the consignment liable to detention and re-export.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024 · MEFCC O.M. dated 15-12-2023

A word of counsel

The most common error on this tariff line is assuming that CDSCO registration for a new laparoscope automatically covers a used or refurbished variant of the same device. The used/refurbished track is a separate restricted-import regime under MEFCC conditions, and a consignment of refurbished laparoscopes arriving with only the CDSCO new-device registration will be detained at the port of import pending MEFCC condition compliance. Verify the equipment's condition-of-import status against the CBIC Instruction 25/2024-Customs permitted list before placing the purchase order.

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Frequently asked

Does HSN 9018 90 96 require BIS certification?

No. Laparoscopes 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, read with G.S.R. 102(E) dated 11-02-2020, with an additional MEFCC-administered restriction for used or refurbished equipment.

Which used or refurbished laparoscopes are permitted for import under the CBIC instructions?

CBIC Instruction 08/2024-Customs dated 05-04-2024, as modified by Instruction 25/2024-Customs dated 28-10-2024, provides the current list of medical equipment permitted in old or refurbished condition; only models explicitly listed may be imported, subject to MEFCC O.M. conditions dated 15-12-2023.

Does CDSCO registration need to be obtained before shipment, or can it be completed after arrival?

CDSCO registration must be in place before the bill of entry is filed; customs out-of-charge cannot be granted without it, and a consignment arriving without valid registration is liable to detention and ground rent accumulation pending regularisation or re-export.

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