BIS Certification for Medical Textile Products

Medical textiles are various fibre-based materials intended for medical purposes. Medical textile is a sector of technical textiles that focuses on fibre-based products used in health care applications such as prevention, care, and hygiene. It is a new field that is the result of a combination of textile technology and medical science.

From the hygienic materials and hospital bed sheets, curtains to surgical masks, gowns, etc. used in operation theatres, even surgical threads, bandages and artificial bones, ligaments, artificial kidneys, livers, there are touches of technological and smart textiles everywhere. Medical textiles have been playing an important role in medicine for centuries.

Keeping in view the protection and health of human beings and to ensure optimum quality of product, the Bureau of Indian Standards has published, Medical Textiles Quality Control Order, 2022, to bring Medical textiles under mandatory BIS certification.

The Bureau of Indian Standards (BIS) is the National Standards Body of India that develops and publishes Indian Standards, implements Conformity Assessment Schemes, recognize & runs laboratories for Conformity Assessment, implements Hallmarking, Works for Consumer empowerment, conducts capacity-building programs on quality assurance and represents the country in ISO & IEC.

• Under sections 16, 17, and 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016), the Central Government is of the opinion that it is necessary so to do in the public interest, and after consulting the Bureau of Indian Standards, hereby makes the Order –Medical Textiles (Quality Control) Order, 2022.

• As per this (Quality control) order, all the manufacturers of Medical textiles are obligated to bear the Standard Mark under a license from the Bureau in accordance with Scheme-I of Schedule-II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018

• Penalty for contravention. – Any person who contravenes the provisions of this Order shall be punishable by the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016).

For  the specification and performance requirements, the Bureau of Indian Standards has developed standards for the following Agro textiles :

Medical textile products :

·       Sanitary Napkins

·       Baby Diaper

·       Reusable Sanitary Pad, Sanitary Napkins, Period Panties

·       Shoe Covers

·       Dental Bib/ Napkins

·       Bedsheet and Pillow Cover

Indian Standard for the above Medical textile products and the corresponding Title :

• IS 5405 – Sanitary Napkins – Specification (Second Revision)
• IS 17509 – Disposable Baby Diaper - Specification
• IS 17349 – Medical Textiles – Shoe Covers - Specification
• IS 17354 – Medical Textiles – Dental bib/ Napkins - Specification
• IS 17630 - Medical Textiles – Bed Sheet and Pillow Cover Specification

Timeline for the Implementation :

For MSMEs: 1 Year from the date of Publication in the Official Gazette

For Self-Help Groups: 2 Years from the date of Publication in the Official Gazette

For Others: 6 months from the date of Publication in the Official Gazette

Benefits of getting BIS Certification for Medical textiles to sell in the Indian Market with our help

BIS Certification means that a certain product conforms to the quality standards set up by the government.

• Medical Textiles must obtain the BIS License, and violators are penalized with the material and a significant sum as a fine.
• Getting certification improves the probability of your product surviving and competing in the market.
• Customers tend to buy BIS-certified products as they ensure safety and standard quality. Hence, with certified products, you can win the confidence and trust of the buyer.
• With the word of mouth of such a client list, you can establish your credibility in the market.

Hence, with a renowned brand, you can raise the standard and benchmark the market value of the product.

Requirements to get the BIS license for Medical textiles

·       Conformity of Raw Materials as per above mentioned Indian Standards for Medical textiles

·       In-house testing laboratory for mandatory tests

·       Competent Quality Control Personnel

·       Adherence to the BIS guidelines for Medical textiles as per mentioned Indian standards

·       There are 4 major categories of documents required to get the BIS license:

a.   Administrative Details

b.   Technical Details

c.    Quality Control Personnel Details

d.   Commercial Details

Expenses involved in obtaining the BIS certificate for Medical textiles :

·       BIS Fee :

o   Application Fees

o   Audit Charges (Consolidated)

o   License Fee

o   Marking Fee

·       Testing Charges :

o   Sample test Fee

In the certification process, product testing is the most important stage as it determines whether the quality of the product meets Indian standards.

·       Consultancy and other charges : Expenses will be different for Indian Manufacturers and Foreign Manufacturers accordingly.

Role of ERCS Private Limited in getting your product certified :

• To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product follows the specified Indian Standard Specifications (ISS), which we directly interpret to you from the BIS officials as per the Indian Standards.
• ECRS Private Limited will be your friend, philosopher and guide in the whole process of getting your product certified by the concerned authorities/ departments.

It is always better to consult with an experienced team, such as ERCS Pvt Ltd., for a smooth certification process.

For more information, please feel free to contact us at info@elitasrcs.com or call at +91-9076611770 / +91-9076611766.