Catheters (for urine, stool)

Catheters for urine and stool drainage

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 39 10 (Catheters for urine, stool) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as mandated by G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must ensure that mandatory documents — certificate of analysis, batch release certificate, and consignment label — are uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

9018 39 10

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 catheters as listed in G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. Registration must cover the specific device and manufacturer; an unregistered device is not importable and is liable to seizure under the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017 (MOHFW notification)
2
Upload the certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc) in e-Sanchit before the bill of entry is assessed. Customs out-of-charge will not be granted until all three documents are verified in the system.
CBIC CCR · e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
If the consignment comprises old or refurbished catheters, verify that the specific equipment category appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and updated by Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical devices outside that permitted list is prohibited.
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 satisfies customs clearance — without uploading all three e-Sanchit documents (0010dc, 0030dc, 0110dc) at the bill-of-entry stage. A bill routed through the PGA-facilitated channel that lacks even one of these uploads will be held for manual verification by the proper officer, triggering detention, demurrage, and ground-rent exposure at the port of import.

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Frequently asked

Does HSN 9018 39 10 require BIS certification?

No, catheters for urine and stool drainage 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 (0010dc), batch release certificate (0030dc), and consignment label (0110dc). Out-of-charge is not granted until the proper officer confirms all three are present in e-Sanchit.

Can refurbished or second-hand catheters be imported under this tariff line?

Only if the specific device category appears on the permitted list for old or refurbished equipment under CBIC Instruction 08/2024-Customs dated 05-04-2024, as updated by Instruction 25/2024-Customs dated 28-10-2024; import of refurbished devices outside that list is prohibited.

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