Syringes, with or without needles

Syringes with or without needles, medical use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 31 00 (Syringes, with or without needles) 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) governing import of listed medical devices. CDSCO registration and mandatory document upload in e-Sanchit are binding conditions at the bill-of-entry stage before out-of-charge is granted.

What this is

HSN code

9018 31 00

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 CDSCO

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 syringe product under the conditions of G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. Confirm the registration is current and covers the specific device class and manufacturer before the purchase order is placed.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Upload all three 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). Out-of-charge will not be granted until all three are verified in e-Sanchit.
CCR mandatory-document requirement; e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
If importing syringes in old or refurbished condition, verify that the specific equipment appears on the permitted list in CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical devices not on that list 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 frequent error on this tariff line is presenting a valid CDSCO registration but omitting one or more of the three mandatory e-Sanchit documents — particularly the Batch Release Certificate (0030dc) — treating it as optional for well-known device brands. All three documents are independently mandatory; a missing upload triggers detention at the port and accumulating demurrage, regardless of the registration's currency or the consignment's clinical urgency.

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Frequently asked

Does HSN 9018 31 00 require BIS certification?

No, syringes with or without needles are not within the BIS Quality Control Order regime. 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, with mandatory CDSCO registration and e-Sanchit document compliance at the bill of entry.

Which documents must be uploaded in e-Sanchit and what are their document codes?

Three documents are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all must be uploaded in e-Sanchit before out-of-charge is granted at any port of import.

Can refurbished or second-hand syringes 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 and Instruction 25/2024-Customs dated 28-10-2024; syringes not appearing on that list may not be imported in old or refurbished condition.

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