Clinical diapers

Clinical diapers, disposable absorbent hygiene articles

BIS QCO APPLICABLE · ISI MARK SCHEME · IS 17509

HSN 9619 00 40 (clinical diapers) is covered by a Bureau of Indian Standards Quality Control Order. Conformity to IS 17509:2021 is mandatory under the ISI Mark Scheme with effect from 01 January 2025 for large and medium enterprises, and from 01 April 2025 for small and micro enterprises, under the Medical Textiles Quality Control Order Second Amendment 2025. No separate customs-clearance overlay applies beyond the mandatory document verification requirement at the bill of entry stage.

What this is

HSN code

9619 00 40

Chapter

96 · Miscellaneous manufactured articles

BIS QCO

Applicable · ISI Mark Scheme · CM/L required

Indian Standard

IS 17509:2021 · effective 01-01-2025

Applicable Partner Government Agencies

BISBIS·Bureau of Indian Standards

Compliance steps

1
Source only from a Bureau of Indian Standards CM/L-licensed manufacturer holding a current licence against IS 17509:2021. Verify the supplier's CM/L number, licensed product scope, and licensed manufacturing facility on the BIS online register before placing the purchase order.
Medical Textiles Quality Control Order Second Amendment 2025 · S.O. 4634(E) dated 23-10-2024 · Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018
2
Confirm that the enforcement date applicable to the foreign manufacturer's enterprise size has been reached: large and medium enterprises are covered from 01-01-2025, small and micro enterprises from 01-04-2025. Retain documentary evidence of the supplier's enterprise classification against the enterprise-size threshold.
S.O. 4(E) dated 01-01-2025 · S.O. 3526(E) dated 30-07-2025 · Medical Textiles Quality Control Order Second Amendment 2025
3
Ensure every clinical diaper unit in the consignment bears the ISI mark and the supplier's CM/L licence number per Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018. Marking must appear on the product or its innermost packaging, not on the outer carton alone.
Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018 · S.O. 4634(E) dated 23-10-2024
4
Upload the Certificate of Analysis, batch release certificate, and label of consignment into e-Sanchit before the bill of entry is filed. The Proper Officer verifies these mandatory documents before granting Out-of-Charge; absence of any one document triggers detention.
CCR mandatory document requirement: Certificate of Analysis [0010dc] · Batch Release Certificate [0030dc] · Label of Consignment [0110dc] · e-Sanchit filing obligation
5
If the consignment qualifies as a Schedule A exempted goods category, retain and produce documentation establishing the exemption basis under Para 2 of the Medical Textiles Quality Control Order as amended. The BIS QCO obligation is not waived absent a confirmed Schedule A carve-out.
Medical Textiles Quality Control Order Second Amendment 2025 · S.O. 4634(E) dated 23-10-2024 — Para 2 exemption schedule

A word of counsel

The most common failure on this tariff line is assuming a single implementation date applies to all suppliers: the 01 January 2025 date governs large and medium enterprises, while small and micro enterprises are covered only from 01 April 2025. Importers who source from a small-enterprise manufacturer and apply the large-enterprise enforcement date — or vice versa — risk either premature rejection of a compliant consignment or, more critically, acceptance of an uncertified consignment that is in fact already within scope. Verify the manufacturer's enterprise-size classification under the Micro, Small and Medium Enterprises Development Act, 2006 before determining which cut-off applies.

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Frequently asked

Does HSN 9619 00 40 require BIS certification?

Yes. Clinical diapers must conform to IS 17509:2021 and bear the ISI mark under a BIS CM/L licence, mandatory under the Medical Textiles Quality Control Order Second Amendment 2025 from 01 January 2025 (large and medium enterprises) or 01 April 2025 (small and micro enterprises).

Do small and micro enterprise manufacturers face the same enforcement date as large manufacturers?

No. Large and medium enterprises are covered from 01 January 2025; small and micro enterprises are covered from 01 April 2025. The enterprise-size classification of the foreign manufacturer — not the importer — determines which date applies.

Are any clinical diaper imports exempt from the IS 17509:2021 requirement?

Exemptions exist for goods listed in Schedule A of the Medical Textiles Quality Control Order as amended from time to time. The importer must establish the exemption basis under Para 2 of the Order; the BIS QCO obligation is not waived by default.

Does a single CM/L licence cover all diaper variants and manufacturing facilities of a supplier?

No. The CM/L licence is scope-specific by product specification and manufacturing facility; variants outside the licensed scope or produced at an unlicensed plant are not covered, and customs will detain a consignment on any scope mismatch with the BIS register.

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