How to Obtain BIS Certification for Medical Textile Products in India?

In the healthcare industry, ensuring the safety and quality of products has become essential. The textile products, like bandages and surgical masks, are directly used by the patients. While the maintenance of these items is essential for hygiene purposes. Ensuring proper hygiene helps to avert infections and also enhances comfort. Furthermore, the Indian government plays an essential role. In India, the Bureau of Indian Standards is the national regulatory authority that operates the whole operation of medical textiles. From the manufacturing of textile products to the distribution, all activities are operated by the BIS.

Apart from operating the operations, BIS is also set to set the safety and quality regulations for the products. By setting the rules, it encourages the manufacturers to meet to comply with Indian standard requirements. The major work of the Bureau of Indian Standards is to ensure and verify that the products sold in India are safe and reliable. However, when the topic turns to medical textiles, the BIS certification becomes crucial. Through the medical textile certification, the manufacturers are allowed to use the ISI mark on their products. This guide will explore how the medical textile manufacturers can secure the BIS license and many other aspects. 

Why is BIS Certification So Important for Medical Textiles?

The medical textile products, like gowns, masks, and many others, are used for specific purposes. They are not a simple fabric of cloth but play an instrumental role in the healthcare sector. These products directly interact with the human body; therefore, such textile products require more safety and quality care. Here is why BIS for textile manufacturers is vital: 

Ensuring Patient Safety: Getting serious about the health of patients is the most important reason for BIS certification. The surgical gowns and wound dressings are used by the patients during the treatment. If these medical textile products are not cured properly, they can release harmful substances. Therefore, the license ensures that surgical gowns or wound dressings must be free from reactive substances. Ensuring the safety standards protect the patients from infections or allergic reactions. 

Quality Assurance: The ISI mark on medical textile items acts as a guarantee of quality. The BIS registration process for textile products involves a thorough testing procedure. During the product testing, their durability and performance standards are verified. By setting the quality benchmark, BIS prevents possible allergies or reactions. 

Preventing Substandard Products: The market credibility can be imbalanced when the products do not test properly. Improper checking of medical textiles leads to flooding the markets with poor-quality products. Meanwhile, a medical textile BIS registration certificate filters the product’s quality before presenting it in Indian markets. It is crucial to halt the marketing of substandard medical textile products.

Building Trust: The ISI mark on the products is a guarantee to the consumers as well as healthcare professionals that the products meet strict authority requirements. It directly boosts the trust of consumers by adhering to relevant Indian standards. 

Mandatory Requirement: Medical textile products are used to cure patients. Due to direct connection to the patients, the textile product manufacturers are required to be BIS certified. Complying with the BIS standard for textile products goes beyond mere legal obligation. It signifies that the manufacturers will not get market entry until they register with the regulatory authority. 

International Recognition: The BIS license for medical textiles sets a legal benchmark that meets the international market requirements. It sets the facilities to trade internationally. 

Which Medical Textile Products Need a BIS License?

By issuing the quality control orders (QCOs), the government of India has outlined the specific textile products that need a mandatory BIS certificate. The authority has issued the quality control orders to ensure medical fibers. The items that require mandatory BIS registration include:

1. Sanitary Napkins
2. Baby Diapers
3. Reusable Sanitary Pads/Sanitary Napkins
4. Dental Bibs or Napkins
5. Medical Surgical Face Masks
6. Surgical Gowns and Drapes
7.  Bandages like crepe bandages, Plaster of Paris bandages, and elastic bandages
8. Medical bedsheets and pillow covers
9. X-ray Detectable Gauze Swabs, Laparotomy Sponges, and many more

Procedure for Acquiring the BIS License for Medical Textile Products

Securing the medical textile BIS certification can become easier by understanding its steps. The key stages of registration are:

Step 1: Magnify the Relevant Indian Standard (IS)

Before starting the process of BIS certification for textiles, the manufacturers need to know which Indian Standard (IS) is required for it. By identifying the relevant Indian Standard, it becomes easy to maintain the safety and quality standards. 

Step 2: Prepare Necessary Documents

• If required, the Authorization letter 
• Applicant Manufacturing license 
• Premises registration documents
• Manufacturing process information
• Product testing reports from a certified BIS laboratory
• Machine and equipment testing list details
• If required, the certificate of incorporation
• If required, the certificate of MSME
• If required, a  trademark registration certificate
• A complete premises layout plan
• Production flowchart information 
• Raw material used list
• ISO 9001 certificate (if applicable). 

Step 3: Prepare Your Factory and Product for Compliance

After identifying the relevant Indian Standard for your product, you need to ensure that your manufacturing process meets the authority requirements. This means:

• Quality Control System: To manage the quality of the product’s raw material, your manufacturing premises must have a proper quality control facility. 
• In-house Testing Facilities: According to the IS requirement, the manufacturers of medical textiles should have their own in-house testing facilities. The in-house testing facility is required to conduct the basic product testing. 
• Product Design and Material: Before the market presentation of the textile products, ensuring their standards, like design, materials, and manufacturing methods, is essential. The structure of products should meet the exact BIS requirements. 

Step 4: AIR for the Foreign Manufacturer

If a foreign manufacturer wants to sell the medical textile products in the Indian market, they need to appoint an Authorized Indian Representative (AIR). The appointed AIR will deal with the BIS on your behalf and is responsible for fulfilling the requirements of authority related to BIS registration. 

Step 5: Submit the Application 

This is the stage where you officially deal with the Bureau of Indian Standards by submitting an application form. The application includes: 

• Online Application: Since digital registration was introduced, the entire BIS certification of textiles has become online. For application submission, register through the BIS portal. 
• Application Form: Complete the application form by filling in the details related to product certification. 
• Necessary Documents: Attach the required documents with the application form.
• Application Fee: Pay the prescribed fee by BIS.

Step 6: Application and Document Review

To ensure the accuracy, the submitted application and the documents will be reviewed by an official of BIS. If they found any mistakes or an absent document, they raised a query. You need to provide the additional information about yourself and your manufacturing unit. Prepare the supplementary certificates to address authority inquiries without delay.

Step 7: Factory Inspection by BIS Officials

After the complete verification of the application and documents, a premises inspection will be conducted by BIS officials:

• Premises Manufacturing Audit: An on-site inspection might take place to verify the manufacturing facility and production process, as well as the quality control measures. 
• Sample Collection: During the inspection of premises, BIS officials will collect textile samples for their testing. 

Step 8: Grant of BIS License

If the premises inspection goes well and the product samples meet the specified test requirements, the Bureau of Indian Standards authority will allot a medical textile products license. After getting the license from BIS, the manufacturers can bear the ISI mark on their products. Meanwhile, the license is valid for a specific period. Before its expiry, apply for BIS license renewal.

Step 9: Post-Certification Surveillance

Obtaining the BIS for medical textiles is an ongoing obligation. Even after getting the license, the manufacturers are required to adhere to the authority’s compliance with standards. A sudden audit can be conducted by the BIS to ensure that the manufacturers are meeting the relevant standard of the BIS textile. 

Final Thoughts | BIS for Textile Manufacturing in India

For the medical textile product manufacturers, securing the BIS registration certificate is essential in India. The medical textile license is the golden pass for businesses to enter Indian markets. Registration for your products determines commitment to safety, quality, and customers’ trust. While the manufacturers can successfully navigate the certification procedure by understanding the need for the BIS standard for the textile industry.

The symbol of ISI on your products not only provides market access but also demonstrates a commitment to a safer and healthier environment in India. Commence your registration process with a reliable consultant. Get in touch with LegalRaasta experts who specialize in providing a comprehensive guide and service related to BIS license registration.