Hilerio venus fistula needles

Haemodialysis needles for arteriovenous fistula access

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 32 30 (Hilerio venus fistula needles) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a listed medical device under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Certificate of analysis, batch release certificate, and consignment label must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

9018 32 30

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
Batch release certificate from CDSCO
Certificate of analysis 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 arteriovenous fistula needle as a listed medical device under G.S.R. 102(E) dated 11-02-2020. All conditions of registration, including foreign-manufacturer registration and Authorised Indian Representative appointment, must be satisfied before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Upload the mandatory documents in e-Sanchit before customs out-of-charge: certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc). Bills not routed through the PGA for NOC must still carry these uploads for the proper officer's verification.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024
3
Confirm whether the consignment is new or refurbished: CBIC Instructions 08/2024-Customs and 25/2024-Customs specify the list of medical equipment permitted in old or refurbished condition. Fistula needles not on that permitted list must be imported as new; a refurbished consignment of a non-listed item is liable to confiscation.
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 presenting a CDSCO registration that covers the device class but does not specifically name the foreign manufacturing facility for this product. G.S.R. 102(E) conditions require facility-level registration, and a registration scoped to a different facility or a different needle model results in consignment detention pending rectification — a process that accrues demurrage and ground rent at the port of import.

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Frequently asked

Does HSN 9018 32 30 require BIS certification?

No, tubular metal needles for medical use are not within the BIS Quality Control Order regime. 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 document codes must be uploaded in e-Sanchit at the bill of entry for this tariff line?

Three documents are mandatory: certificate of analysis (0010dc), batch release certificate (0030dc), and consignment label (0110dc); all must be uploaded before the proper officer grants out-of-charge.

Can refurbished or second-hand fistula needles be imported under this HSN?

Only if the specific equipment appears on the permitted list in CBIC Instruction 08/2024-Customs dated 05-04-2024 or CBIC Instruction 25/2024-Customs dated 28-10-2024; items not on that list must be imported as new or face confiscation.

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