Hollow needles for injection, aspiration, biopsy and transfusion

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 32 20 (Hollow needles for injection, aspiration, biopsy and transfusion) 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 is conditional on CDSCO registration and full compliance with the conditions prescribed in that notification.

What this is

HSN code

9018 32 20

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 hollow needles as a medical device listed under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. Registration must be current and the certificate uploaded in e-Sanchit before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
Upload all three mandatory documents in e-Sanchit before out-of-charge: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). Absence of any one document is grounds for detention pending PGA NOC.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO PGA facilitation protocol
3
If the consignment comprises old or refurbished equipment, verify inclusion in the list published under 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 common error on this tariff line is uploading a CDSCO registration certificate that covers a different device class or a related product family but does not specifically cover hollow needles for aspiration, biopsy, or transfusion — each sub-indication may carry a distinct registration scope. A registration valid for injection needles alone will not satisfy a customs officer reviewing a consignment declared for biopsy or transfusion use, and the consignment will be detained until a corrected or additional CDSCO registration is uploaded in e-Sanchit.

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Frequently asked

Does HSN 9018 32 20 require BIS certification?

No. No BIS Quality Control Order covers hollow needles under this tariff line. 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 Label of Consignment (0110dc). Out-of-charge will not be granted until all three are verified in e-Sanchit.

Can refurbished hollow needles be imported under HSN 9018 32 20?

Only if the specific equipment appears in the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 or its modification under Instruction 25/2024-Customs dated 28-10-2024; refurbished devices not on that list are barred from import.

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