Hilerial or venous shunts

Hilerial or venous shunts for medical or surgical use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 91 (Hilerial or venous shunts) 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) vide G.S.R. 102(E) dated 11-02-2020. Import requires a valid CDSCO registration and compliance with all conditions specified in that notification before customs out-of-charge is granted.

What this is

HSN code

9018 90 91

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
Certificate of analysis from manufacturer
Batch release certificate from manufacturer

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 hilerial or venous shunt under the Medical Devices Rules, 2017, satisfying all conditions of G.S.R. 102(E) dated 11-02-2020. The registration must be current at the time of filing the bill of entry; an expired or absent registration results in consignment detention.
G.S.R. 102(E) dated 11-02-2020 issued by MOHFW · Medical Devices Rules, 2017
2
Upload all mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). Customs out-of-charge will not be granted until all three documents are verified in e-Sanchit.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024
3
If importing in old or refurbished condition, confirm the device is listed in the equipment schedule permitting such imports under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Importing a refurbished device not on the approved list constitutes an unauthorised import and is liable to seizure.
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 alone is sufficient without pre-uploading all three e-Sanchit document codes — 0010dc, 0030dc, and 0110dc — before the bill of entry is filed. Customs proper officers are instructed to withhold out-of-charge even on PGA-facilitated bills if any of these documents are absent in e-Sanchit; ground rent and demurrage begin accruing from vessel discharge, not from the date of the document deficiency notice.

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Frequently asked

Does HSN 9018 90 91 require BIS certification?

No, hilerial or venous shunts 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.

Which e-Sanchit document codes are mandatory at the bill of entry for this HSN?

Three documents must be uploaded: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all three must be present before customs out-of-charge is granted.

Can hilerial or venous shunts be imported in a refurbished or second-hand condition?

Only if the specific device is listed in the equipment schedules annexed to CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024; devices not on those lists may not be imported in old or refurbished state.

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