HOW TO GET BIS CERTIFIED FOR MEDICAL TEXTILE PRODUCTS IN INDIA

INTRODUCTION

The healthcare sector relies heavily on medical textiles, which serve vital functions ranging from hygiene and protection to wound care and surgical applications. Products such as baby diapers, surgical face masks, eye pads, sanitary napkins, shoe covers, adhesive plasters, and compression bandages are essential for treatment and patient care, infection control, and hygiene maintenance.

The Government of India mandates BIS certification for all medical textile manufacturers and importers to ensure that these products meet strict quality and safety standards. This certification guarantees compliance with Indian standards and assures the end-user of the product’s safety, reliability, and effectiveness.

In this article, we provide a detailed overview of BIS certification, its importance, the BIS registration process, and other key considerations such as the cost of BIS certification, documentation required, and how to apply for a BIS certificate in India.

WHAT IS BIS CERTIFICATION?

The Bureau of Indian Standards (BIS) is India’s national standard body, responsible for the development of Indian standards, quality assurance, and certification of products. BIS certification ensures that products conform to Indian safety and quality benchmarks.

For medical textiles, BIS plays a vital role in verifying that each product performs as intended in medical environments, minimizes health risks, and supports patient recovery. Products certified under the BIS license India scheme carry the ISI mark, symbolizing adherence to the applicable Indian Standard (IS).

IMPORTANCE OF BIS CERTIFICATION FOR MEDICAL TEXTILES

The application of textiles in the medical field has expanded with innovations in both materials and medicine. Today’s medical textiles range from simple dressings to advanced products such as scaffolds for tissue regeneration. Their direct contact with the human body makes it imperative that they meet stringent quality and performance standards.

Without BIS certification, medical textiles cannot legally be sold in India. Certification also:

• Ensures public safety
• Enhances consumer trust
• Prevents the circulation of substandard or hazardous materials
• Promotes fair market competition

Moreover, in the context of medical device regulation in India, BIS certification acts as a regulatory gatekeeper for certain textile-based medical products.

How TMWALA Can Help: Navigating the regulatory landscape can be complex, but TMWALA assists manufacturers in identifying applicable IS standards, compiling documentation, and ensuring end-to-end compliance with BIS norms for medical textiles.

MEDICAL DEVICE REGULATION IN INDIA AND MEDICAL TEXTILES

India’s medical device regulatory framework, governed by the Central Drugs Standard Control Organization (CDSCO), classifies medical products and imposes compliance mechanisms based on risk levels. Many medical textiles, such as bandages, surgical masks, gowns, and diapers, fall under this regulatory umbrella.

BIS certification is aligned with these regulatory objectives. It ensures that the production, packaging, labelling, and performance of medical textile products conform to relevant Indian Standards (IS codes).

BIS REGISTRATION PROCESS: STEP-BY-STEP

Acquiring BIS certification can be complex, particularly for first-time applicants. Below is a breakdown of the BIS registration process for medical textile products:

1. Documentation Preparation

Before starting the application, manufacturers must gather all relevant documents, including:

• Laboratory Test Reports (as per Indian Standard)
• Factory Registration Certificates
• Manufacturing process flow chart
• In-house testing facilities documentation
• Details of the Authorised Signatory

 2. Application Submission

Once the documents are ready, the application is submitted through the official BIS portal along with applicable fees.

3. Scrutiny of Application

BIS officials review the application and supporting documents to ensure completeness and accuracy.

4. Factory Audit

An on-site inspection is conducted at the manufacturing facility by BIS auditors. During the audit, product samples are collected for laboratory testing.

5. Sample Testing

The collected samples are tested in BIS-recognized laboratories to confirm compliance with the Indian Standard relevant to that product.

 6. Grant of BIS License

If the product meets all the specified criteria, BIS grants a license allowing the manufacturer to use the ISI Mark on the product packaging and labels.

This process generally takes 4 to 6 months, depending on the complexity of the product and the responsiveness of the applicant.

TMWALA expedites the BIS registration process by coordinating factory audits, preparing compliance-ready documentation, and managing lab testing, minimizing turnaround times and costly rejections.

HOW TO APPLY FOR A BIS CERTIFICATE?

For manufacturers wondering how to apply for a BIS certificate, the process is centralized and fully digital. Here’s a quick checklist:

• Visit the official BIS website
• Select the applicable product category (medical textiles)
• Register an account and complete the online application
• Upload the required documents
• Pay the application fee
• Wait for the scheduling of the factory audit and testing
• On approval, receive your BIS license digitally

It is advisable to consult a BIS compliance expert or authorized agent to avoid delays or rejections.

Why Choose TMWALA? With deep industry knowledge and BIS liaison experience, TMWALA provides expert support at every stage of the application from IS code selection to post-license marking compliance.

APPLICABLE BIS STANDARDS FOR MEDICAL TEXTILES

BIS has issued 54 Indian Standards (IS codes) covering different types of medical textiles. These standards specify the technical specifications, safety parameters, and test methods for each product.

Here are a few examples:

Manufacturers must determine the exact applicable IS code(s) for their product(s) before applying.

BIS CERTIFICATION COST

The BIS certification cost can vary depending on product type, factory size, testing needs, and scope of certification. However, typical components include:

• Application Fee– Paid at the time of submission
• Audit Fee– Covers the on-site inspection and associated logistics
• Sample Testing Fee– For lab analysis at BIS-approved facilities
• License Fee– Charged annually
• Marking Fee– Based on product type and quantity manufactured

Additionally, manufacturers should factor in the cost of upgrading their in-house testing facilities, especially if they don’t already meet BIS standards. On average, certification may cost anywhere between ₹75,000 to ₹2,50,000 per product per manufacturing location.

CONCLUSION

With the growing reliance on medical textiles in modern healthcare, ensuring product safety and compliance is not optional; it is essential. The BIS license India scheme offers a structured, legally mandated way to guarantee that medical textile products meet the highest standards of quality and performance.

Manufacturers aiming to enter or expand within the Indian healthcare market must understand the importance of BIS certification, comply with medical device regulations in India, and be prepared for the BIS registration process. Though the process may seem daunting, the long-term benefitsbrand credibility, legal clearance, and market trustmake the effort worthwhile.

For a smooth and successful application, it’s highly recommended to work with compliance experts who can guide you through the detailed steps of how to apply for a BIS certificate, assist in documentation, and ensure timely audits and approvals.