Skip to main content
Access IndiaPLATFORM
HomeHSNChapter 38HSN 3822 19 10

Pregnancy test kit

Pregnancy test kit, in-vitro diagnostic reagent

MEFCC CLEARANCE

HSN 3822 19 10 (Pregnancy test kit) is subject to import controls administered by the Ministry of Environment, Forest and Climate Change (MEFCC) under the Office Memorandum dated 15 December 2023, which restricts import of high-end and high-value used or refurbished medical equipment. Certificate of analysis, batch release certificate, and label of consignment must be uploaded in e-Sanchit before customs out-of-charge.

What this is
HSN code
3822 19 10
Chapter
38 · Miscellaneous chemical products
Primary regulator
MEFCC · O.M. dated 15-12-2023 (used/refurbished medical equipment import conditions)
Customs documentation
  • Certificate of analysis from drug authority
  • Batch release certificate from manufacturer
  • Label of consignment from importer
Applicable Partner Government Agencies
MEFCCMEFCC·Ministry of Environment, Forest and Climate Change
Compliance steps
  1. 1
    Upload the mandatory e-Sanchit documents 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). The proper officer will verify these uploads before granting out-of-charge.
    CCR mandatory document requirement · document codes 0010dc, 0030dc, 0110dc
  2. 2
    Where the pregnancy test kit is imported as used or refurbished equipment, confirm that all conditions prescribed in the Ministry of Environment, Forest and Climate Change O.M. dated 15 December 2023 are satisfied before shipment. Import of such high-end, high-value used or refurbished medical equipment is Restricted and subject to those conditions.
    O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
A word of counsel

The most common error on this tariff line is importing used or refurbished pregnancy test kits without verifying compliance against the MEFCC O.M. dated 15 December 2023, which imposes specific conditions on high-end, high-value second-hand medical equipment. New units require only the three e-Sanchit documents, but a misclassification of device condition — treating a refurbished kit as new — can result in consignment detention and restricted-import enforcement at the bill of entry stage.

Need a regulatory steer on this product?
Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.
Speak to an Expert
Frequently asked
Does HSN 3822 19 10 require BIS certification?
No, pregnancy test kits under this tariff line are not covered by any BIS Quality Control Order. Import is governed by the Ministry of Environment, Forest and Climate Change O.M. dated 15 December 2023 for used or refurbished units, with mandatory e-Sanchit documentation applicable to all imports.
Which documents must be uploaded in e-Sanchit for a pregnancy test kit consignment?
Three documents are mandatory: certificate of analysis — drug (0010dc), batch release certificate (0030dc), and label of consignment (0110dc). These must be uploaded before the proper officer grants out-of-charge.
Does the MEFCC restriction on used or refurbished medical equipment apply to all pregnancy test kits?
No. The MEFCC O.M. dated 15 December 2023 applies specifically to high-end, high-value used or refurbished medical equipment; new pregnancy test kits are not subject to those additional conditions, though the e-Sanchit document requirements remain applicable to all imports.
Last verified against gazette notifications: 2026-05-16. Source: MEFCC / Indian Customs CUSDATA.
Related