Vetrasonic lithotripsy instruments

Vetrasonic lithotripsy instruments for veterinary use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 97 (Vetrasonic lithotripsy instruments) 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 is conditional on compliance with the registration and import-licensing requirements prescribed in G.S.R. 102(E), and second-hand or refurbished equipment is separately governed by CBIC Instruction 08/2024-Customs and Instruction 25/2024-Customs.

What this is

HSN code

9018 90 97

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
MOHFW G.S.R. 102(E) 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 Vetrasonic lithotripsy instrument in accordance with G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must cover the specific device category and must be current; an import licence from CDSCO is also required under the same notification.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
If importing in old or refurbished condition, confirm that the device model appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. Refurbished medical devices not covered by that list are not eligible for import and will be detained or directed for re-export.
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 a new device automatically authorises import of a refurbished version of the same equipment. The CBIC Instructions 08/2024-Customs and 25/2024-Customs create a separate, device-specific permitted list for old and refurbished equipment — a device absent from that list cannot be imported in used condition regardless of new-device registration status, and consignments presented at customs without the permitted-list confirmation face detention and re-export at the importer's cost.

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Frequently asked

Does HSN 9018 90 97 require BIS certification?

No, no BIS Quality Control Order covers Vetrasonic lithotripsy instruments. 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 CDSCO registration and import licensing.

Which documents must be uploaded in e-Sanchit at the bill of entry for this device?

The CDSCO registration certificate and import licence issued under G.S.R. 102(E) dated 11-02-2020 are the mandatory PGA documents; for refurbished units, evidence of inclusion in the CBIC Instruction 08/2024-Customs or 25/2024-Customs permitted list must also be presented before out-of-charge.

Can second-hand Vetrasonic lithotripsy instruments be imported into India?

Only if the specific equipment model is listed in the permitted schedule under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024; instruments not appearing on those lists may not be imported in used or refurbished condition.

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