BIS Certification for Medical Textiles Ensures Quality and Compliance in Healthcare

The medical textile covers a wide range of items, from elastic adhesive dressing to absorbent cotton and various others. The Indian medical textile is the core part of the healthcare industry. To fulfill the various needs, whether it is for doctors, patients, or the general public, medical textiles serve a crucial role. But how are the safety and quality benchmarks of these products ensured? To ensure these benchmarks, following a specific and accurate testing method is critical.

Manufacturers are required to obtain BIS certification for medical products in this context. The Bureau of Indian Standards has included medical textile products in its compulsory registration requirements. From small to big medical textile products, everyone requires BIS certification. This comprehensive guide will explore how the BIS medical textile standard ensures quality and compliance, including the process for obtaining BIS registration online and the associated legal requirements. 

Understanding BIS Certification for Medical Textiles

In India, obtaining BIS certification for medical textiles is essential. It is mandatory to examine the safety, quality, and efficacy standards before selling in Indian markets. This is because these medical products must meet the high-quality standards for use in healthcare and personal hygiene. Meanwhile, BIS (Bureau of Indian Standards), which serves as the national body, sets and implements these standards. By mandating the compulsory registration, the government protects consumers from harmful medical textile products. Unregistered or substandard products can lead to adverse allergies for users.

The most recent establishment is the Quality Control Order. It was established in August 2025 and is valid till December 31, 2025. Its motive is to provide provisions for a sale period for uncertified old stock.

Why Quality and Compliance are Non-Negotiable?

The medical textile products, from simple gauze to surgical dressing gowns, come into direct contact with patients and healthcare experts. The quality of these products falls between life and death. This means certification for medical textiles is not a legal requirement but showcases a commitment to patient safety and health. In addition, the BIS mark on the products guarantees that they meet specific requirements and have been tested under stringent criteria.

BIS registration is critical because: 

• Patient Safety First: The initial motive of the ISI mark for medical devices is to provide a safe and valuable product to patients. For the safety of users, the medical device products are tested for multiple factors such as chemical composition, biocompatibility, and sterility. These tested factors demonstrate that the product won’t be the cause of infection or any other allergic reactions.
• Preventing Substandard Goods: For unsafe products, BIS certification serves as a barrier. This means the authority gets access and prevents the entry of low-quality and untested products. It doesn’t give access to such products in the Indian markets. Only BIS-certified products are allowed to be sold in markets with a valid license. 
• Boosting Trust and Credibility: To gain the confidence of healthcare professionals and patients, the businesses need to align with set standards. The ISI mark on the products is the symbol of trust and guarantee. 

How Many Products Under the BIS Mandate?

The Ministry of Textiles has released a Quality Control Order (QCO) that outlines the mandatory BIS certification list in India. Consequently, for the designated list of medical products, BIS registration is obligatory. The most frequently required medical products that necessitate a license include:

BIS Certification Advantages for Manufacturers and Consumers

BIS Certification for medical textiles is crucial for manufacturers and consumers. It provides multiple benefits that are: 

For Manufacturers

1. Market Access and Competitive Advantage: To legally sell the medical textile products in the Indian market, the manufacturers are required to bear the ISI mark on their products. Apart from it, it gives a competitive place in markets, enhances consumers’ confidence, and increases market share. 
2. Enhanced Brand Reputation: The ISI mark for medical devices is a commitment to its safety and quality. It directly develops a strong and reputable image. 
3. Reduced Business Risk: BIS certification is the way to improve textile products. It decreases the risk associated with non-compliance. 

For Consumers

1. Guaranteed Safety: The Mark of ISI on the products guarantees to the buyers that the item they are purchasing is safe and has been vetted. 
2. Reliable Performance: The confidence of consumers will increase more with a product that gives the expected performance. 
3. Informed Choice: The presence of the BIS symbol on medical textile products enables consumers to make informed purchasing decisions. They can easily identify a safe product for themselves. 

Conclusion | BIS Medical Textile Quality Control Order

To manage India’s healthcare ecosystem accurately, the Bureau of Indian Standards (BIS) mandates certification. BIS certification for medical devices is a tool that makes a connection between the authority, manufacturer, and consumers. In India, the BIS serves as a protective measure by approving only certified medical textile products.

With the large number of medical textile businesses established, the Ministry of Textiles issued a few quality control orders. Recently, the Textiles Ministry has released the Medical Textile (Quality Control) Order, 2024. To increase your brand credibility, BIS certification apply online now. To simplify the registration process, leverage a professional or a BIS certification consultant in India. Get in touch with LegalRaasta, which assists with medical textile registration.