The Government of India, through the Ministry of Textiles, has issued the Medical Textiles (Quality Control) Order, 2024, making BIS certification mandatory for several medical textile products. The objective of this Quality Control Order (QCO) is to ensure that products supplied in the Indian market meet prescribed quality, safety, hygiene, and performance standards. Manufacturers and importers dealing in the notified products must obtain a valid BIS licence before manufacturing, selling, importing, or distributing these products in India.
What is the Medical Textiles (Quality Control) Order, 2024?
The Medical Textiles (Quality Control) Order, 2024 has been issued under the provisions of the Bureau of Indian Standards Act, 2016. It supersedes the earlier Medical Textiles (Quality Control) Order, 2023 and mandates that specified products conform to the applicable Indian Standards and bear the ISI Mark under a BIS licence issued under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018.
Implementation Date
The Order came into force on the date of its publication (23 October 2024). However, compliance deadlines vary depending on the product category.
Schedule A Products
Implementation Date: 1 January 2025
- Sanitary Napkins
- Baby Diapers
- Reusable Sanitary Pads
- Reusable Sanitary Napkins
- Period Panties
Schedule B Products
Implementation Date: 1 April 2024
- Shoe Covers
- Dental Bibs/Napkins
- Medical Bedsheets
- Pillow Covers
Products Covered Under the QCO
| Product | Applicable Indian Standard |
| Sanitary Napkins | IS 5405:2019 |
| Baby Diapers | IS 17509:2021 |
| Reusable Sanitary Pads / Period Panties | IS 17514:2021 |
| Shoe Covers | IS 17349:2020 |
| Dental Bib/Napkins | IS 17354:2020 |
| Medical Bedsheets & Pillow Covers | IS 17630:2021 |
Who is Affected?
The Order is applicable to:
- Indian manufacturers of notified medical textile products
- Foreign manufacturers exporting notified products to India
- Brand owners getting products manufactured under third-party manufacturing arrangements
- Importers sourcing products from overseas manufacturers
Every manufacturer must obtain a BIS licence before placing these products on the Indian market.
Exemptions
The QCO does not apply to:
- Products manufactured exclusively for export.
- Products listed in Schedule A that are manufactured by eligible Self-Help Groups (SHGs), as defined in the Order.
Mandatory BIS Requirements
Manufacturers must ensure that:
- Products conform to the applicable Indian Standard (IS).
- Products bear the ISI Mark.
- A valid BIS licence under Scheme-I is obtained. Manufacturers often work with a BIS registration consultant in India to streamline documentation, product testing, factory inspections, and licence approval.
- Manufacturing facilities maintain consistent quality systems.
- Products undergo testing in accordance with the applicable Indian Standard.
BIS Certification Procedure
Step 1: Gap Analysis
Review manufacturing processes, testing facilities, and quality management systems against BIS requirements.
Step 2: Documentation Preparation
Prepare manufacturing documents, quality manuals, process flow charts, testing procedures, calibration records, and legal documents.
Step 3: Product Testing
Products are tested in BIS-recognized laboratories to verify compliance with the applicable Indian Standard.
Step 4: BIS Application Submission
Submit the online application with supporting documents and test reports.
Step 5: Factory Inspection
BIS officials conduct a factory audit to verify manufacturing capability, testing facilities, process controls, and quality assurance systems.
Step 6: Sample Verification
Samples may be drawn during the inspection for independent laboratory testing.
Step 7: Grant of Licence
After successful evaluation and compliance, BIS grants the ISI licence authorizing the use of the Standard Mark.
Estimated Timeline
| Activity | Approximate Timeline |
| Documentation Preparation | 1–2 Weeks |
| Product Testing | 1–2 Weeks |
| BIS Application Review | 2–3 Weeks |
| Factory Inspection | As scheduled by BIS |
| Grant of Licence | 30–45 Days (subject to successful compliance and BIS processing) |
Consequences of Non-Compliance
Manufacturing, selling, importing, or distributing notified products without a valid BIS licence after the applicable implementation date may lead to:
- Regulatory action by BIS.
- Product seizure or market withdrawal.
- Financial penalties under the BIS Act.
- Legal prosecution.
- Suspension of imports.
- Loss of customer confidence and business opportunities.
Why BIS Certification is Important
BIS certification:
- Demonstrates compliance with Indian regulations.
- Builds consumer confidence.
- Improves product quality and consistency.
- Enables legal sale in India.
- Reduces the risk of regulatory enforcement.
- Enhances brand reputation.
How Kar Parivartan LLP Can Help
Kar Parivartan LLP provides comprehensive BIS consulting services, including:
- Product applicability assessment
- Documentation preparation
- Testing coordination with BIS-recognized laboratories
- BIS application filing
- Factory inspection support
- Technical compliance guidance
- Post-certification compliance (AMC)
- Licence renewal and surveillance support
Our experienced team supports both Indian and foreign manufacturers throughout the entire certification process.
Need BIS Certification for Medical Textiles?
Kar Parivartan LLP offers complete support for BIS Certification, ISI Mark Licensing, Factory Audit Assistance, Product Testing Coordination, Documentation, Licence Renewal, and Annual Compliance Management (AMC).
📧 Email: bis.sales@karparivartan.com
📞 Contact: +91 7428718855
Partner with Kar Parivartan LLP to ensure seamless BIS compliance and uninterrupted market access for your medical textile products.
FAQs
Is BIS certification mandatory for medical textiles?
Yes. The notified products under the Medical Textiles (Quality Control) Order, 2024 must comply with the applicable Indian Standards and be covered by a BIS licence.
Which products are covered?
Sanitary napkins, baby diapers, reusable sanitary pads, period panties, shoe covers, dental bibs, bedsheets, and pillow covers.
Can imported products be sold without BIS certification?
No. Imported products covered under the QCO must also comply with the applicable BIS requirements before being sold in India.
Is the ISI Mark mandatory?
Yes. Products covered under this Order must bear the ISI Mark under a valid BIS licence.
Are export products covered?
No. Products manufactured exclusively for export are exempt from the QCO.
How long does BIS certification take?
Typically, the certification process takes 45–90 days, depending on testing, documentation, factory readiness, and BIS processing timelines.
What happens if a manufacturer fails to comply?
Non-compliance may result in regulatory action, penalties, product recalls, and restrictions on manufacturing or sale.
Can Kar Parivartan LLP assist foreign manufacturers?
Yes. We provide end-to-end BIS certification support for both Indian and overseas manufacturers, including Foreign Manufacturers Certification Scheme (FMCS) assistance where applicable.
