BIS Certification For Crepe Bandage [IS 4605: 1981]

BIS Certification for Crepe Bandage falls under the range of Medical Textile products. The use of medical textile products varies in the medical sector. Medical textile products cover feminine hygiene, including sanitary napkins, infant diapers, crepe bandages, dressings, and expensive and specialized products, such as surgical sutures, etc.

Why Do You Need BIS Certification For Crepe Bandage?

BIS Certification For Crepe Bandage of medical devices ensures maintenance of required safety standards. Medical textiles need to maintain safety standards for medical products to ensure the occurrence of any health hazards that any substandard medical textiles can cause. Medical textiles are used in direct contact with the body to cover wounds, provide personal care, etc. These products are essential for healthcare and safety. 

Therefore, crepe bandages and other products in this range must match the Indian Standards outlined to ensure their safety and quality. BIS certification ensures that the product meets safety requirements.

Is It Important To Obtain BIS Certification For Crepe Bandage?

Yes, it is important to get BIS Certification for Crepe Bandage as it assures the quality and safety standard of the product. Apart from this, having BIS mark on the product also boosts consumer trust and avoids legal penalties.

A BIS certificate is given to Crepe Bandage only when it is of excellent quality. BIS certification for crepe bandage ensures that it has passed all required tests and that the product is made as per the requirements of the Indian Standard for trustworthiness, safety, and quality. It helps to protect consumers from purchasing sub-standard and flawed products.

Lab testing at certified BIS labs is done of the crepe bandage to ensure it matches the requirements as per IS standard 4605:2020

What Documents Do You Need To Apply For BIS Certification For Creppe Bandage?

There are multiple documents which is required to apply for BIS License for Crepe Bandage, here we have listed them. The required general documents are listed below:

1. Business License 
2. Trademark License
3. Application form 
4. Authorization letter 
5. Laboratory Test Reports
6. MSME certificate 

Technical documents

1. Manufacturing process flow chart 
2. Product Literature 
3. List of testing equipment & machinery 
4. Technical Specification 
5. Plant layout 

It is important to ensure that the documents submitted are accurate and complete to ensure a successful BIS certification process.

Process To Apply BIS Certification For Crepe Bandage

There are two procedures for obtaining a BIS license for Crepe Bandage:

1. Normal procedure
2. Simplified procedure 

Normal Procedure

• The first step in the registration process is to file an online application with the BIS department using a login ID and the required fees and necessary documents.
• Shortcomings are communicated by the dept, if any. A common misunderstanding noticed is that the applicant’s signature stamp is affixed instead of the actual signature. If a brand registration certificate is shared, the brand’s name doesn’t match the brand on the product, etc.
• The BIS department communicates the audit date, and the auditor conducts the audit on the applicant’s premises. The auditor withdraws product samples for independent testing.
• Products are tested according to relevant Indian standards in labs approved by BIS. If the sample collected complies with the requirements of the IS standard, BIS shall grant the license.

Simplified Procedure

• Under the simplified procedure, testing is done independently from the BIS-approved laboratory. 
• They fill out an online application with the BIS department through a login ID, along with the required fees and documents.
• Application is recorded, documents submitted are scrutinized, and shortcomings, if any, are communicated. 
• BIS officials audited the applicant’s premises, and a sample was drawn for independent testing.
• A BIS license is granted if the product complies with the requirements as per IS standards.

Timeline Of BIS Certification For Crepe Bandage

It typically takes around 40-45 days to obtain a registration license from BIS, including a 15- 20-day testing period. The standard procedure takes longer than the simplified procedure since the testing is done later.

However, the simplified procedure grants the license within 30-35 days. This expedited timeline is achieved by sending the product sample for initial testing, allowing the application to be processed concurrently, thus saving time.

Validity Of BIS Certification For Crepe Bandage?

A license from the BIS authority is granted for 1 year, which can be renewed for 1 year to 5 years. Renewal must be completed within 90 days. If the license is not renewed within 90 days, it will expire. After that, a fresh application will be required to continue using the ISI mark.

What Is The ISI Standard For Crepe Bandage?

The ISI Standard for Crepe Bandage is IS 4605: 1981. Lab testing at certified BIS labs is done of the crepe bandage to ensure it matches the requirements as per IS standard.

Our Assistance For BIS Certification For Crepe Bandage

We are a team of ex-government officials, legal consultants, and experienced advocates. We provide complete guidance and support throughout the registration process. Our team will assist you in finalizing the IS  standard, documentation, lab testing, and auditing.

What Is The HSN Code For Crepe Bandage?

The HSN (Harmonized System of Nomenclature) code for crepe bandages is 3005. This code falls under the category of “Wadding, gauze, bandages and similar articles,”. It is used for medical, surgical, dental, or veterinary purposes. According to experts, India export maximum Crepe Bandage to UAE, Nepal, and Germany.