Ophthalmoscopes

Ophthalmic instruments and appliances, ophthalmoscopes

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 50 10 (Ophthalmoscopes) 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). Compliance with the registration and conditions prescribed in that notification is mandatory before import is permitted, and refurbished or old equipment is subject to additional controls under CBIC Instruction 08/2024-Customs.

What this is

HSN code

9018 50 10

Chapter

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

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
MOHFW notification 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 ophthalmoscope under the conditions prescribed in G.S.R. 102(E) dated 11-02-2020. The registration must cover the specific device and manufacturer; import of an unregistered medical device is prohibited and attracts detention and confiscation at the port of entry.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
If importing ophthalmoscopes in old or refurbished condition, confirm that the specific equipment is listed in the permitted categories published under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical equipment not on the permitted list is not allowed.
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 registration for the new-device variant also covers refurbished or second-hand units of the same model. The permitted-list regime for old and refurbished equipment under CBIC Instructions 08/2024-Customs and 25/2024-Customs operates independently of the G.S.R. 102(E) registration; a consignment of refurbished ophthalmoscopes not appearing on the permitted list will be detained and faces re-export or confiscation regardless of registration status.

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Frequently asked

Does HSN 9018 50 10 require BIS certification?

No, ophthalmoscopes are not subject to any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, which mandates device registration before import.

Are refurbished ophthalmoscopes permitted for import into India?

Only if the specific equipment appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024; equipment not on that list may not be imported in old or refurbished condition.

What happens if an ophthalmoscope is imported without CDSCO registration?

The consignment is liable to detention at the port of entry, and the proper officer may order re-export or confiscation under the conditions prescribed in G.S.R. 102(E) dated 11-02-2020; criminal liability under the Medical Devices Rules framework may also apply.

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