For blood-grouping

Blood-grouping diagnostic reagents and laboratory kits

MEFCC CLEARANCE

HSN 3822 13 00 (Blood-grouping diagnostic reagents) is subject to oversight by the Ministry of Environment, Forest and Climate Change (MEFCC) under its O.M. dated 15-12-2023, which conditions the import of high-end and high-value used or refurbished medical equipment. At the bill of entry, the Central Board of Indirect Taxes and Customs (CBIC) mandates upload of a certificate of analysis, batch release certificate, and label of consignment in e-Sanchit before out-of-charge is granted.

What this is

HSN code

3822 13 00

Chapter

38 · Miscellaneous chemical products

Primary regulator

MEFCC · O.M. dated 15-12-2023 (used/refurbished medical equipment conditions)

Customs documentation

Certificate of analysis from supplier
Batch release certificate from supplier
Label of consignment from importer

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Where the blood-grouping reagent equipment being imported is used or refurbished and classified as high-end or high-value, ensure compliance with all conditions stipulated in the Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023 before shipment. Critical care medical equipment is specifically excluded from the restricted category and follows a separate clearance path.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
2
Upload all three mandatory documents in e-Sanchit before filing the bill of entry: certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc). The proper officer will verify these uploads before granting out-of-charge; consignments with missing uploads are detained pending document rectification.
CBIC e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is misreading the critical-care-equipment carve-out as a broad exemption covering all diagnostic reagent kits. The MEFCC O.M. dated 15-12-2023 restricts only high-end, high-value used or refurbished equipment; new blood-grouping reagents do not attract that restriction but still require the full e-Sanchit document set (0010dc, 0030dc, 0110dc) — omitting any one of the three triggers detention at the port of entry pending upload.

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Frequently asked

Does HSN 3822 13 00 require BIS certification?

No, blood-grouping diagnostic reagents are not covered by any BIS Quality Control Order. Import is governed by the Ministry of Environment, Forest and Climate Change conditions under the O.M. dated 15-12-2023, with mandatory e-Sanchit document uploads required at the bill of entry.

Which documents must be uploaded in e-Sanchit for this tariff line?

Three documents are mandatory: certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc). All three must be uploaded before out-of-charge is granted by the proper officer.

Does the MEFCC restriction apply to new blood-grouping reagents or only to used equipment?

The MEFCC O.M. dated 15-12-2023 applies specifically to high-end and high-value used or refurbished medical equipment; new diagnostic reagent consignments are not subject to those conditions but remain subject to the mandatory e-Sanchit document requirements.

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