Other
Paper-based and medical-textile sanitary and hospital articles
HSN 4818 90 00 (residual household, sanitary and hospital articles of paper pulp, cellulose wadding or textile fibres) is covered by a Bureau of Indian Standards Quality Control Order. Conformity to IS 17349:2020, IS 17354:2020, and IS 17630:2021 is mandatory under the ISI Mark Scheme by virtue of the Medical Textiles (Quality Control) Order and its Second Amendment 2025. Paper Import Monitoring System registration administered by the Directorate General of Foreign Trade applies as a separate customs-clearance overlay.
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Identify the product sub-type before sourcing: IS 17349:2020 applies to medical-textile shoe covers; IS 17354:2020 applies to medical-textile dental bibs or napkins; IS 17630:2021 applies to medical-textile bed sheets and pillow covers. Source only from a BIS CM/L-licensed manufacturer whose licence specifies the matching IS and product scope.Medical Textiles QCO Second Amendment 2025 · S.O. 4634(E) dated 23-10-2024 · S.O. 04(E) dated 01-01-2025 · S.O. 3526(E) dated 30-07-2025
- 2Verify the supplier's BIS CM/L number on the BIS online register before placing the purchase order. Confirm that the licence is current, identifies the correct IS number and version year, and covers the specific product variant and manufacturing facility being shipped.Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018 · Medical Textiles QCO Second Amendment 2025
- 3Ensure every article bears the ISI standard mark and the supplier's CM/L number on the product itself. Marking on outer packaging alone does not satisfy the marking obligation under Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018.Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018
- 4Register the consignment under the Paper Import Monitoring System no earlier than 75 days and no later than 5 days before the expected arrival date. Fee ₹500; the automatic registration number is valid for 75 days. Quote the PIMS registration number and its expiry date on the bill of entry.DGFT Notification 11/2015-2020 dated 25-05-2022; PIMS effective from 01-10-2022 for bills of entry filed on or after that date
- 5If the consignment transits through or is processed in an SEZ, FTWZ, or EOU, confirm PIMS registration status. Registration is required at point of entry into the SEZ/FTWZ/EOU; re-registration at DTA clearance is required only if processing has changed the 8-digit HS code to a PIMS-covered tariff line.DGFT Policy Circular 41/2015-2020 dated 05-07-2022; DGFT Policy Circular 45/2015-2020 dated 23-01-2023
The most common error on this tariff line is treating the three Indian Standards as interchangeable or applying IS 17630:2021 (bed sheets and pillow covers, operative from 01-04-2024) to a consignment of shoe covers or dental bibs, which are separately governed by IS 17349:2020 and IS 17354:2020 respectively. A CM/L licence issued against one IS does not authorise import of a product variant mapped to a different IS — customs verifies product description against the licensed IS at the bill-of-entry stage, and a scope mismatch triggers detention regardless of whether the supplier holds a BIS licence for another product in the same family.