Medical Textiles
Shoe Covers – IS 17349:2020
Strategic Recommendations – Shoe Covers
Engage Early with BIS & Labs
All manufacturers (large, medium, small, and micro) must comply with IS 17349:2020 under Scheme-I by 1 April 2024.
Partner with Compliance Experts
Consult BIS/QCO specialists ERA Compliance team to streamline license application, documentation, and testing coordination. Full technical support available for shoe cover manufacturers.
Contact ERA Support Team
📧 cs@eraglobal.co.in | 📞 +91 9599296331 | 💬 WhatsApp
Assistance provided for certification filing, lab setup, and product labeling with ISI mark.
Track Notifications & Circulars
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Do a Gap Assessment
Identify uncertified inventory. Ensure packaging carries the ISI mark and discontinue any non-compliant product sale or manufacture.
| Section | Details |
|---|---|
| Product Name | Shoe Covers |
| IS Standard | IS 17349:2020 |
| Title of IS | Medical Textiles — Shoe Covers — Specification |
| Quality Control Order | Medical Textiles (Quality Control) Order, 2024 |
| Notification & Amendments | Notified via S.O. 4634(E) dated 23 October 2024 - Supersedes Medical Textiles QCO, 2023 [S.O. 4247(E)] - Referred in Amendment Order 2025 [S.O. 04(E)] — no change for this item |
| Final Enforcement Date | 1 April 2024 – Applies to all manufacturers (Large, Medium, Small & Micro) |
| Objective & Scope | To standardize quality and hygiene requirements of disposable and reusable shoe covers used in healthcare and sterile environments |
| Products Covered | All types of shoe covers made from medical-grade non-woven or polymeric materials used for infection control and contamination prevention |
| Exemptions | Items meant exclusively for export |
| Industries Impacted | Hospitals and Clinics - Pharmaceutical Manufacturing & Cleanrooms - Medical Garments and PPE Suppliers |
| Mandatory Compliance | Mandatory BIS Certification under Scheme-I - Product must comply with IS 17349:2020 - ISI Marking required on every unit or packaging |
| Next Steps for Stakeholders | Apply to BIS for certification - Get products tested from BIS-approved labs - Stop sale/manufacture of uncertified stock post 1 April 2024 |
| Legal Framework & Enforcement | Enforced under the BIS Act, 2016 – Sections 16, 17, and 25(3); implementation by BIS and Textiles Committee |
| Penalties for Non-Compliance | Seizure of non-compliant goods - Cancellation of BIS license - Fines or imprisonment up to 2 years, or both |
| Conclusion | From 1 April 2024, all Shoe Covers sold in India must be BIS certified and conform to IS 17349:2020. The product is not exempt under Schedule A and must carry the ISI mark. Export-only goods are the sole exemption. Early compliance is critical to avoid penalties. |
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Notification
The product Shoe Covers is governed under the Medical Textiles (Quality Control) Order, 2024, notified by the Ministry of Textiles through S.O. 4634(E) dated 23 October 2024. This notification supersedes the 2023 Order. Although a subsequent Amendment Order (S.O. 04(E), dated 1 January 2025) was issued, there was no change to the enforcement timeline for this product.
Final Enforcement Date is 1 April 2024.
Overview
Shoe covers are essential components of hygiene and safety protocols in healthcare and cleanroom environments. Designed to prevent cross-contamination from footwear, these products are used in hospitals, laboratories, pharmaceutical units, and food-handling zones.
Objective & Scope
The standard IS 17349:2020 outlines the material, construction, and performance criteria for shoe covers intended for use in medical and hygiene-critical applications. The objective is to ensure that only certified products that meet uniform safety and quality benchmarks are manufactured or sold in India.
Products Covered
The specification applies to medical-grade shoe covers made from nonwoven, polymeric, or other hygienic barrier materials. These may include both disposable and reusable variants used for infection control in medical and allied settings.
Exemptions Provided
Only products meant exclusively for export are exempt from the provisions of the QCO.
Industries Impacted
- Healthcare and Medical Services(Hospitals & Clinics)
- Pharmaceutical Manufacturing and Packaging
- Diagnostic Laboratories and Research Facilities
- Cleanroom and Food Processing Environments
- PPE and Medical Consumables Manufacturing
Mandatory Compliance Requirements
Effective 1 April 2024, it is mandatory for all manufacturers and sellers of shoe covers in India to obtain BIS certification under Scheme-I (ISI Mark Scheme). All shoe covers must conform to the IS 17349:2020 standard and bear the ISI mark. Post-enforcement, uncertified products are not permitted in the Indian market.
Next Steps for Stakeholders
Stakeholders must:
- Apply for a BIS license specific to IS 17349:2020
- Submit product samples for type testing at BIS-recognized laboratories
- Undergo factory inspection as per BIS norms
- Ensure labeling and ISI marking on all certified stock before sale
- Discontinue manufacturing and selling non-certified items post-deadline
Legal Provisions, Enforcement & Penalties
This requirement is enforced under the BIS Act, 2016, specifically Sections 16, 17, and 25(3). Implementation is overseen by BIS and the Textiles Committee. Penalties for non-compliance include:
- Seizure of non-compliant goods
- Suspension or cancellation of BIS license
Fines and/or imprisonment up to two years
Conclusion
All manufacturers, importers, and sellers of shoe covers must ensure mandatory BIS certification under IS 17349:2020 by 1 April 2024. Only BIS-certified products with the ISI mark will be permitted in the Indian market. Timely compliance is critical to avoid enforcement action, legal penalties, and disruption of operations.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.