Other

Other ophthalmic instruments and appliances

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9018 50 90 (Other ophthalmic instruments and appliances) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under 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 ophthalmic equipment is additionally restricted under conditions notified by the Ministry of Environment, Forest and Climate Change (MEFCC) vide O.M. dated 15-12-2023.

What this is

HSN code

9018 50 90

Chapter

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

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020 (Medical Devices Rules, 2017)

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 ophthalmic device under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. Devices listed in that notification may not be imported without a valid registration; upload the registration certificate in e-Sanchit prior to out-of-charge.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
If importing used or refurbished high-end ophthalmic equipment, confirm the specific equipment model appears on the permitted list in CBIC Instruction 08/2024-Customs dated 05-04-2024 or Instruction 25/2024-Customs dated 28-10-2024. Equipment not on the permitted list is Restricted and subject to the MEFCC O.M. dated 15-12-2023 conditions for high-value used medical equipment.
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 importing used or refurbished ophthalmic equipment without verifying its appearance on the CBIC-notified permitted lists. A device that is not enumerated in Instruction 08/2024-Customs or Instruction 25/2024-Customs is treated as a Restricted import regardless of CDSCO registration status, and the consignment is liable to detention and re-export. New and refurbished equipment attract separate compliance tracks; treating them interchangeably at the bill-of-entry stage is the primary cause of port detention on this HSN.

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Frequently asked

Does HSN 9018 50 90 require BIS certification?

No, no BIS Quality Control Order covers this product family. Import of ophthalmic instruments and appliances under this tariff line is governed by the Central Drugs Standard Control Organisation under G.S.R. 102(E) dated 11-02-2020, with additional restrictions on used and refurbished equipment under the MEFCC O.M. dated 15-12-2023.

Which used or refurbished ophthalmic equipment may be imported under this HSN?

Only equipment specifically enumerated in the permitted lists attached to CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024 may be imported in used or refurbished condition; all other high-end or high-value equipment under this heading is Restricted.

Does CDSCO registration alone satisfy import clearance for new ophthalmic devices under this HSN?

For new devices, valid CDSCO registration under G.S.R. 102(E) dated 11-02-2020 is the primary requirement. For used or refurbished devices, CDSCO registration is necessary but not sufficient — compliance with the MEFCC O.M. dated 15-12-2023 conditions and appearance on the CBIC permitted lists are also mandatory.

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