On September 17, 2023, the Ministry of Textiles issued the Medical Textiles (Quality Control) Order, 2023 to regulate the quality of medical textiles, including Shoe Covers. This order mandates that all such products produced, sold, or imported in India must meet specific quality standards outlined by the Bureau of Indian Standards (BIS), ensuring they are safe and durable for use, particularly in healthcare settings. 

If you manufacture or sell Shoe Covers, this order will directly affect your business operations. The government introduced this regulation under the BIS Act, 2016, in the interest of public safety, after consultations with the BIS. 

Key Provisions of the Medical Textiles (Quality Control) Order, 2023 

1. Title and Implementation Timeline 

This regulation is officially titled the Medical Textiles (Quality Control) Order, 2023. It comes into effect as per the item-wise timeline specified in the order: 

   • For Small & Micro Enterprises (SMEs), Medium, and Large scale enterprises, the deadline to comply is October 1, 2024. 

2. Mandatory BIS Certification 

Manufacturers of Shoe Covers must obtain BIS certification to use the ISI Mark, signifying compliance with Indian Standard IS 17349:2020. 

   • The products must bear this mark to indicate they meet the necessary quality and safety standards. 

   • Products meant solely for export or items manufactured by Self Help Groups (SHGs) are exempt from this requirement. 

3. Exemptions 

   • Goods produced for export are exempt from this regulation. 

   • SHGs manufacturing these textiles are also excluded from the requirement for BIS certification. 

4. BIS as Certifying Authority 

The Bureau of Indian Standards (BIS) will serve as the certifying and enforcement authority. BIS will ensure that all manufacturers, importers, and sellers comply with the standards set by the order. 

5. Penalties for Non-Compliance 

Any person who fails to comply with the provisions of this order will face penalties as per the BIS Act, 2016. This regulation is designed to ensure the quality of Shoe Covers, promoting hygiene and safety, particularly in medical facilities. 

This order represents a crucial step in improving the quality and safety of medical textiles in India.

Implementation Dates: Date of implementation for Small Enterprises, Micro Enterprises, Medium & Large Enterprises: 1^st October 2024.

BIS Certification for Shoe Covers IS 17349: 2020