Medical textiles serve a crucial protective role in healthcare, catering to a wide array of medical needs. These items span from mass-produced disposables like infant diapers and feminine hygiene products to intricately specialized textiles used in surgical sutures, blood filtration, and tissue scaffolding. Given their critical function in ensuring user health and safety, it is mandatory for manufacturers to attain BIS certification for medical textiles.

Testing the properties and performance of medical textiles using appropriate methods according to Indian standards is crucial. These standards outline the performance requirements for medical textiles in various medical applications, ensuring their effectiveness and safety. Compliance with applicable Indian standards is mandatory for all medical textiles, and BIS certification ensures that these products meet the specified requirements.

All medical textiles, including baby diapers, eye pads, dressings, sanitary pads, napkins, shoe covers, surgical face masks, bandages, adhesive plasters, handloom cotton lint, caps, and other similar products, must obtain BIS certification. This certification is essential to guarantee that these items adhere to Indian standards, ensuring their safety and reliability for consumers.

Before proceeding, let's delve into what is BIS certification?

What is BIS (Bureau of Indian standard)?

BIS, the Indian certification authority, oversees the establishment of standards, marking, and quality certification of goods. Through diverse certification schemes, BIS ensures the provision of top-quality, secure products to the public.

BIS license:BIS offers a product certification program, commonly referred to as the ISI Mark certification scheme, which grants a BIS license to manufacturers allowing them to use the ISI mark on products for sale in the Indian market. Products bearing the ISI Mark assure consumers that they adhere to the relevant Indian standards.

In order to sell their products in the Indian market using the standard mark, manufacturers are required to obtain BIS certification from BIS. This certification is only granted once it is confirmed that the product meets all the necessary requirements of relevant Indian standards. Manufacturers must ensure that their product aligns with all applicable Indian standards to obtain the BIS license. By obtaining BIS certification, companies can build consumer trust, prioritize consumer health, and guarantee the safety of their products from physical harm.

After understanding what a BIS License entails, you might be curious about the process of acquiring BIS certification for your product. Let's delve into the steps involved in obtaining BIS certification specifically for medical textile products.

Process of BIS certification for Medical Textile

Here's the process involved in obtaining BIS certification for medical textiles:

• Documentation:Before applying for BIS certification for your medical textile product, ensure all necessary documentation is completed.

• Application Submission:Once all relevant documents are ready, submit the application form and supporting materials through the BIS Portal.

• Scrutiny of application:BIS officials will meticulously review each document and application submitted.

• Audit of manufacturing premises:After the initial review, BIS will assign an auditor to inspect the manufacturing premises. During this audit, samples may be collected for testing.

• Sample testing:Samples collected during the audit will undergo testing at a BIS-approved laboratory to confirm compliance with Indian standards.

• Grant of BIS Licence: If the product meets the specified Indian standard, BIS will issue a BIS license to the manufacturer.

Documents Required to get BIS certification in India

The documentation needed for BIS Certification comprises both specific and general requirements, encompassing:

• Laboratory Test Reports as per Product Standard

• Factory Registration Documents

• Manufacturing process flow chart

• In-house Testing Facilities

• Details of Authorised Signatory and other related documents

BIS covered medical Textile:

Standardizing medical textiles is essential for safeguarding user health and safety. It involves aligning performance and functional criteria with the latest technological advancements worldwide. High-quality medical textiles are imperative to uphold user well-being and safety.

Yet, the Bureau of Indian Standards has established specific standards for medical textiles, outlined as follows:

What are the costs associated with BIS certification for Medical Textile products?

BIS certification costs include:

• Application fee

• Audit fee

• Sample testing fee

• License fee

• Marking fee

It also necessitated investment in factory facilities, particularly in the installation of testing machinery for in-house factory test labs.

WHY USE ABSOLUTE VERITAS?

Absolute Veritas is a prominent organisation from the private sector of India primarily dealing with the Inspection, Testing, Audits, Certification of products& consulting services to various industries in India and worldwide, ensuring compliance with regulatory standards and industry requirements. Offering a comprehensive range of services including product certification, testing, training, auditing, and compliance services, Absolute Veritas helps manufacturers and importers achieve higher production efficiency and quality standards.

Absolute Veritas (AV) will handle end to end pre-registration request, sample preparation, documentation, testing and application process for FMCS Certification

For any questions regarding the most recent update on FMCS registration licenses, please reach out to us via email at cs@absoluteveritas.com