ISI Mark for medical textile - QCO

ISI Mark Made Mandatory for Medical Textile in India 

To promote the health and safety of healthcare workers and patients, The Ministry of Textiles ordered on September 27, 2023, that the following medical textile products should carry the ISI Mark and conform to the corresponding Indian Standard.

  • Sanitary Napkins: IS 5405:2019 
  • Baby Diaper: IS 17509:2021 
  • Reusable Sanitary Pad, Sanitary Napkin, Period Panties: IS 17514:2021 
  • Shoe Covers: IS 17349:2020 
  • Dental Bib/Napkins: IS 17354:2020 
  • Bedsheet and Pillow Cover: IS 17630:2021 

This order applies to all stakeholders including manufacturers, wholesalers, retailers, and importers engaged in the sale and marketing of finished products in India. 

Note- This Order does not apply to goods or articles designated for export or those produced by Self Help Groups (SHGs).  

Timelines for implementation: 

  • For all other entities: April 1, 2024. 
  • For small and micro-enterprises (SMEs): October 1, 2024.

Any person, who contravenes the provisions of this Order, shall be punishable by the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016)

Access the official notification from here. 

We at Vincular take pride in offering various certification services ranging from BIS-ISI to waste management to PESO certification and so on. So if you want assistance in acquiring ISI certification contact us at fmcs-isi@vincular.in

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