Whether you are a manufacturer, distributor, or healthcare provider getting BIS certification for medical textile is very important. Medical textiles products such as masks, drapes, surgical gowns, wound dressing, etc play a vital role in protecting patients’ health and hygiene. Therefore, guaranteeing these products meet the required BIS registration standards is crucial.

BIS certificate for medical textile products ensures compliance with national standards and enhances the credibility and marketability of these products. In this article, we will explore the significance of BIS certificate for medical textile products, the certification process, and the benefits.

What Is BIS Certification For Medical Textile?

BIS certification for medical textiles ensures the safety and quality of the medical textiles for consumer safety. For medical textiles such as masks, surgical gowns, etc BIS develop standards, test products stability, and then certify BIS certification to the manufacturers.

Once the BIS certificate is granted, the manufacturer can use the BIS mark on their products and ensure consumers the medical textile is reliable, high-quality and safe to use.

What Is The Process Of BIS Certification For Medical Textile?

Follow the below-listed steps to get the BIS certificate for medical textile products:

• Documentation: to get BIS certificate for medical textiles products first of all prepare all the necessary documentation before submitting your application.
• Application Submission: Submit the completed application form along with the supporting documents to the BIS Portal.
• Scrutiny of Application: BIS officials will thoroughly review the submitted documents and application before proceeding to the next step.
• Audit of Manufacturing Premises: After scrutiny, BIS will appoint an auditor to inspect the manufacturing premises. During the inspection, samples will be collected and sent to a BIS-approved laboratory for testing.
• Sample Testing: The collected samples will be tested in a BIS-approved laboratory to ensure they meet the requirements of the applicable Indian standards.
• Grant of BIS License: If the product complies with the specified Indian standards, BIS will grant a BIS license to the medical textile manufacturer.

Also read: Get BIS Certification For Medical Devices

Documents Required To Get BIS Certificate For Medical Textiles Products In India

There are several documents required to obtain BIS certification for medical textiles products in India, listed below:

• Laboratory test reports per product standards
• Factory registration documents
• Manufacturing process flowchart
• Details of in-house testing facilities
• Information on the authorized signatory and other relevant documents

List Of Medical Textile Products Under BIS Certification

The BIS has developed standards for each medical textile to ensure the consumer’s safety and health. Hence, read the full details of the Indian Standards of Medical Textile products list according to the products here:

For more information, read our other blog to get a BIS license for crepe bandages, which covers all the major concerns and queries.

What Is The BIS Certification Cost For Medical Textile Products?

There is no fixed cost of BIS certificate for medical textiles products. However, the typical costs involved in obtaining BIS certification for medical textiles products lists generally include:

• Application fee
• Audit fee
• Sample testing fee
• License fee
• Marking fee

Since the exact costs can vary, we recommend contacting a BIS registration consultancy for detailed information. You can reach us by calling +917669172198 or emailing us at info@bisregistrationcertificate.com.

Is BIS Certification Mandatory For Medical Textiles Products?

Yes, BIS certification for medical textiles is mandatory for certain medical textiles in India, such as surgical gowns, face masks, and bandages, to ensure they meet quality and safety standards​.

Can I Export Medical Textiles Without BIS Certification?

No, you cannot export medical textiles products without getting BIS certification as they must meet Indian standards for safety and quality before exporting.