Mandatory BIS-ISI Certification for Medical Textiles in India
11. January 2024On 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 article | Indian Standard | Title of Indian Standard | Timeline for Implementation |
| 1 | Sanitary Napkins | IS 5405:2019 | Sanitary Napkins – Specification (second revision) | For Small & Micro Enterprises (SME) –October 1, 2024 For Others – April 1, 2024 |
| 2 | Baby Diaper | IS 17509:2021 | Disposable Baby Diaper – Specification | |
| 3 | Reusable Sanitary Pad Sanitary Napkin Period Panties | IS 17514:2021 | Reusable Sanitary Pad/ Sanitary Napkin/ Period Panties -Specification | |
| 4 | Shoe Covers | IS 17349:2020 | Medical Textiles – Shoe Covers – Specification | April 1, 2024 |
| 5 | Dental Bib/ Napkins | IS 17354:2020 | Medical textiles – Dental Bib or Napkins – Specification | |
| 6 | Bedsheets and Pillow Covers | IS 17630:2021 | Medical 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.
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