Blood transfusion apparatus

Blood transfusion apparatus, medical infusion devices

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 32 (Blood transfusion apparatus) 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), which conditions import on device registration and specified compliance requirements. 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 90 32

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 blood transfusion apparatus as a listed medical device under G.S.R. 102(E) dated 11-02-2020. All conditions of registration — including any Authorised Indian Representative appointment — 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
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 presented. The proper officer will verify these uploads prior to granting out-of-charge.
CDSCO mandatory document codes 0010dc, 0030dc, 0110dc · e-Sanchit upload requirement
3
If importing blood transfusion apparatus in old or refurbished condition, confirm that the specific equipment is listed on the permitted schedule in CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical devices not listed in those instructions 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 presenting a valid CDSCO registration but failing to upload all three mandatory e-Sanchit documents — certificate of analysis (0010dc), batch release certificate (0030dc), and consignment label (0110dc) — before the bill of entry. A single missing document code triggers detention and demurrage at the port even where the device registration is current; the proper officer has no discretion to grant out-of-charge until all three codes are verified in e-Sanchit.

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Frequently asked

Does HSN 9018 90 32 require BIS certification?

No. No BIS Quality Control Order covers blood transfusion apparatus under this tariff line. 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 CDSCO device registration as the operative requirement.

Which document codes must be uploaded in e-Sanchit for this medical device at the bill of entry stage?

Three documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Consignment Label (0110dc). All three must be uploaded in e-Sanchit before out-of-charge is granted.

Can blood transfusion apparatus be imported in refurbished or second-hand condition?

Only if the specific equipment appears on the permitted schedule in CBIC Instruction 08/2024-Customs dated 05-04-2024 or CBIC Instruction 25/2024-Customs dated 28-10-2024; refurbished medical devices not listed in those instructions are not permitted for import.

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