Tonometers

Ophthalmic tonometers for intraocular pressure measurement

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 50 20 (Tonometers) 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) via G.S.R. 102(E) dated 11-02-2020. Import is permitted only after the device is registered with CDSCO, and consignments of old or refurbished units are additionally subject to the equipment-category conditions set out in CBIC Instruction 08/2024-Customs and Instruction 25/2024-Customs.

What this is

HSN code

9018 50 20

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 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 tonometer under the Medical Devices Rules, 2017 as mandated by G.S.R. 102(E) dated 11-02-2020. The registration must cover the specific device model and must be current at the time of bill of entry; import of an unregistered medical device attracts detention and confiscation under the Drugs and Cosmetics Act, 1940.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
If importing tonometers in old or refurbished condition, verify that the specific equipment category is listed in the annexure to CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of old or refurbished units not appearing on the permitted-equipment list is prohibited regardless of CDSCO registration status.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024

A word of counsel

The single most common error on this tariff line is assuming that a valid CDSCO registration for the new-device version automatically authorises import of refurbished units of the same model. The old/refurbished permission is a separate determination made against the equipment-category list in the CBIC Instructions; a consignment of refurbished tonometers arriving without confirmed list-inclusion faces seizure at the port of import regardless of the registration certificate on file.

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Frequently asked

Does HSN 9018 50 20 require BIS certification?

No, tonometers 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, pursuant to G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Are there specific conditions for importing refurbished tonometers under this tariff line?

Yes. CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024 provide a list of equipment categories permitted to be imported in old or refurbished condition; only tonometers appearing on that list may be imported in such state.

What happens if a tonometer consignment arrives without CDSCO registration?

An unregistered medical device consignment is liable to detention at the port of import and confiscation under the Drugs and Cosmetics Act, 1940; re-export at the importer's cost is the typical customs outcome where confiscation is not ordered.

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