Needles for suture

Needles for suture, surgical suturing needles

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 32 10 (Needles for suture) 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 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 the suturing needle as a listed medical device under G.S.R. 102(E) dated 11-02-2020. The registration must be current and all conditions specified in the G.S.R. notification — including importer and foreign-manufacturer registration — must be satisfied before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · Medical Devices Rules, 2017
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 submitted. The proper officer will verify these documents are present before granting out-of-charge.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024
3
If the consignment comprises old or refurbished suturing needles, confirm that the specific equipment is listed in the permissible schedule under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical devices outside the listed categories is not permitted.
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 uploading the CDSCO registration certificate without the full documentary triad — certificate of analysis (0010dc), batch release certificate (0030dc), and consignment label (0110dc) — in e-Sanchit. A missing batch release certificate alone is sufficient grounds for the proper officer to withhold out-of-charge, resulting in port detention and demurrage. Each document code must map to the specific consignment batch, not to a prior shipment.

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Frequently asked

Does HSN 9018 32 10 require BIS certification?

No, suturing needles 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 e-Sanchit document codes are mandatory at the bill of entry for this HSN?

Three documents must be uploaded: certificate of analysis under code 0010dc, batch release certificate under code 0030dc, and the consignment label under code 0110dc — all verified by the proper officer before out-of-charge is granted.

Can refurbished or second-hand suturing needles be imported under HSN 9018 32 10?

Only if the specific equipment appears in the permissible list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024; suturing needles not on that list are barred from import in old or refurbished condition.

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