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Mandatory BIS-ISI Certification for Medical Textiles in India

11. January 2024

On September 27, 2023 the Indian Ministry of Textiles has released the “Medical Textiles (Quality Control) Order, 2023”. This publication aims to enhance the quality control measures within the production of medical textiles and key components of healthcare devices. The standards concerned refer to the ISI certification scheme (Scheme I) of the BIS certification.

BIS-ISI certification is required for many different product groups, such as electronics, household appliances, safety glass, etc.

The affected standards will come into effect throughout the course of 2024. BIS certification will be be mandatory for many types of medical textiles.

Here you will find an overview of the affected product groups for which new standards and mandatory BIS certification are expected as well as their implementation dates:

No.Good or articleIndian StandardTitle of Indian StandardTimeline for Implementation
1Sanitary NapkinsIS 5405:2019Sanitary Napkins – Specification (second revision)For Small & Micro Enterprises (SME) –October 1, 2024   For Others – April 1, 2024
2Baby DiaperIS 17509:2021Disposable Baby Diaper – Specification
3Reusable Sanitary Pad
Sanitary Napkin
Period Panties
IS 17514:2021Reusable Sanitary Pad/ Sanitary Napkin/ Period Panties -Specification
4Shoe CoversIS 17349:2020Medical Textiles – Shoe Covers – SpecificationApril 1, 2024
5Dental Bib/ NapkinsIS 17354:2020Medical textiles – Dental Bib or Napkins – Specification
6Bedsheets and Pillow CoversIS 17630:2021Medical Textiles – Bed Sheets and Pillow Covers -Specification

If you are interested in understanding what requirements are needed for your product to be imported into India, please do not hesitate to contact us by email or phone (Europe: +49-69-271 37 69 261, US: +1 773 654-2673). There is no cost or obligation for us to check for you. If a certification need is discovered we can provide a quotation to make sure that all your certification needs are covered.

If you have any questions you can also use our chat-window in the bottom right. (Please check your browser settings if you can’t see the window)

For more information about BIS certification, please refer to our free brochure “BIS Certification Made Easy“.

MPR Author

About the author: Julian Busch is founder and Managing Director of MPR International GmbH
Publisher: MPR International GmbH

Tel.: +49 69 271 37 69 261