Ophthalmic lasers

Ophthalmic lasers for medical and surgical use

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9018 50 30 (Ophthalmic lasers) 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 ophthalmic laser equipment is additionally restricted under the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change (MEFCC) dated 15-12-2023.

What this is

HSN code

9018 50 30

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, MOHFW)

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 laser as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration must be current at the time the bill of entry is filed; an unregistered device is liable to detention and refusal of out-of-charge at the port of import.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
For import of used or refurbished high-end ophthalmic laser equipment, comply with all conditions prescribed in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023. This restriction applies to high-value, non-critical-care medical equipment as designated by the Directorate General of Health Services.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is importing used or refurbished ophthalmic lasers under a valid CDSCO registration without separately addressing the MEFCC Office Memorandum conditions applicable to high-end second-hand medical equipment. CDSCO registration establishes device conformity but does not satisfy the environmental and health-ministry overlay on used equipment; a consignment detained under the MEFCC O.M. conditions remains subject to re-export or confiscation regardless of CDSCO registration status.

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Frequently asked

Does HSN 9018 50 30 require BIS certification?

No, ophthalmic lasers are not covered by any BIS Quality Control Order. Import is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020, issued by the Ministry of Health and Family Welfare, with an additional MEFCC overlay for used or refurbished units.

Does the MEFCC restriction on used medical equipment apply to all ophthalmic lasers or only specific categories?

The restriction under the MEFCC O.M. dated 15-12-2023 applies to high-end and high-value used or refurbished medical equipment other than critical care medical equipment, as designated by the Directorate General of Health Services; new ophthalmic lasers are subject only to CDSCO registration.

What happens if an ophthalmic laser is imported without a valid CDSCO registration?

An unregistered medical device is liable to seizure and confiscation at the port of import, and the importer faces monetary penalty and potential prosecution under the applicable medical devices regulatory framework notified via G.S.R. 102(E) dated 11-02-2020.

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