BIS ISI Registration for Surgical Gloves | Fees, Procedure & Documents Required

Updated on March 30, 2024 02:59:23 PM

The Bureau of Indian Standards is a statutory body that regulates the quality, safety, and reliability of manufacturing goods in India. BIS offers quality certifications under its various schemes for different type of products, including surgical gloves. Manufacturers of surgical gloves must obtain ISI registration to ensure that their products meet Indian regulations and standards that are equivalent to global quality parameters.

To obtain ISI certification, manufacturers must file an online application with BIS licensing authorities and follow the respective registration procedure. Once certification is completed, manufacturers are issued the ISI certificate. The ISI mark guarantees that the product has met all necessary standards. It also helps to build a strong brand image for the manufacturers or producers.

The BIS ISI certification is a valuable asset for any surgical gloves manufacturer and can help to improve the quality, safety, and reliability of their products.

BIS ISI Certificate Sample

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What is the ISI Registration for surgical gloves?

The Bureau of Indian Standards is responsible for issuing ISI Registration Certificate to manufacturers of surgical gloves in India. This certification guarantees that the product meet the necessary quality standards and safety guidelines.

The ISI certification aims to protect consumers from substandard or hazardous products by regulating the quality of products. It establishes a framework for manufacturers to meet the necessary standards, ensuring the dependability, performance, and safety of surgical gloves. BIS certification boosts consumer confidence, promotes fair trade practices, and helps to improve quality in the Indian market.

Manufacturers are also required to have an initial in-house laboratory to test the quality of their products. This is important for all types of manufacturers who choose ISI Registration.

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Documents required for BIS ISI Registration for surgical gloves?

The following are the documents that must be submitted during the registration for a Surgrical Gloves :-

  1. List of Raw materials used
  2. Details of factory Location
  3. Description of Manufacturing process
  4. Details of Machinery
  5. Plant Layout In Details
  6. In-house lab for initial quality checkups
  7. Test report by a BIS recognized Laboratory
  8. Photograph of product
  9. Undertaking
  10. Application form

You can start the BIS certification process for Surgrical Gloves in India right away. All you need to do is reach out to our consultants.

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Fee for ISI registration of Surgrical Gloves

Particulars Fees
Application Fee ₹ 1,000
Sample Test Fee As applicable
License Fee ₹ 1,000
Inspection Charge ₹ 7,000
Professional Fee Starts From ₹ 40,000
Marking Fees As applicable

The aforementioned Fees is exclusive of GST.

Validity of ISI certification for Surgrical Gloves

ISI BIS registration is valid for one year. License holders must renew their license before it expires. The fee for ISI BIS registration is the same as the application fee.

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Procedure of BIS ISI Registration for surgical gloves

The registration process can be broken down into the following steps:

Step 1: Identification of IS standard

Determining the appropriate quality standards for the product before applying for ISI registration is a crucial step in the entire registration process.

Step 2: Documentation and Filing

After the appropriate quality standard has been determined for the product, applicants must provide the relevant information and documentation, which will be attached to the BIS application. Applicants must also provide test reports for their products from BIS-accredited testing laboratories.

Step 3: Verification and inspection

Once the application, application fees, and test report have been submitted, the licensing authorities will conduct a thorough inspection and verification of the documents and premises (in some cases) before issuing a BIS certificate.

Step 4: Issuance of BIS certificate

BIS ISI registration will be issued within 60-90 days of completing all the required steps.

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Setting Up Inhouse Lab - For ISI Registration For manufacturers

  • Manufacturers must have an in-house lab to obtain ISI certification for their products.
  • The lab must have all necessary machinery and testing equipment to test the products before applying for ISI marking.
  • As per BIS guidelines, an initial test should be conducted at the manufacturing plant itself to ensure compliance with Indian standards.
  • Professional Utilities can help you set up your in-house lab for your respective products. Our team of experts is well-versed in Indian quality parameters and can guide you through the entire registration process without any hassle or delay.

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Requirements for Setting up in House Lab for Manufacturers

Testing parameters

  • Thickness
  • pH of Aqueous Extract
  • Dimensions
  • Elongation at Break
  • Tensile Strength

Equipments Required

  • Humidity Chamber
  • Universal Testing Machine
  • Vernier calipers
  • Oven
  • Balance
  • Incubator

Note: few other test parameters and equipment can also be required for the setting up of an Inhouse lab facility.

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Benefits of BIS ISI Registration?

Obtaining ISI registration can help you in the following ways:

  1. Increase Brand Value and Customer Confidence:

    BIS registration is a mark of quality and safety. It shows that your surgrical gloves meets all the required standards and is safe to use. This can help you in increasing your brand value and gaining the confidence of your customers.

  2. Reduce Risk of Product Recalls and Penalties:

    BIS ISI registration can help you in reducing the risk of product recalls and penalties. If your surgrical gloves is not registered with BIS, it can be recalled from the market, and you may be liable to pay penalties.

  3. Access to Government Tenders and Contracts:

    ISI registration is a requirement for many government tenders and contracts. If you are not registered with BIS, you may not be able to participate in these tenders and contracts.

  4. Improved Market Access:

    BIS ISI registration can help you in improving your market access. It shows that your surgrical gloves meets the required standards and is safe to use. This can help you in getting your surgrical gloves approved for sale in more markets.

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Conclusion

The ISI mark not only assures compliance but becomes a symbol of reliability and dedication to excellence. Manufacturers with ISI certification gain a competitive edge, expanding market reach, and fostering long-term success. Embracing ISI certification is not just a necessity. It is a proactive investment in credibility, consumer loyalty, and sustained growth, positioning companies as leaders in quality and safety standards. Hence getting an ISI certificate is important for producers and manufacturers of such products.

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FAQs

What is BIS ISI registration?

BIS ISI registration stands for Compulsory Registration Scheme. It was introduced by the Ministry of Electronics and Information Technology (Meity). Under the registration, all manufacturers and importers of electronic products are now required to obtain BIS certification in order to start business in India.

What is the cost of ISI registration?

The application fee for ISI registration with Professional Utilities starts from ₹ 40,000.

How to get BIS ISI registration?

Professional Utilities can help you get your BIS certificate in just 3 easy steps.

  1. Provide documents & Details
  2. Filing and submission of fee
  3. Issuance of certificate
Do importers of Surgrical Gloves need BIS certification?

Yes,all importers of surgrical gloves must obtain BIS registration for their import business. BIS stands for Bureau of Indian Standards, It is a web-based system that allows businesses to register and obtain certificates of registration for various products.

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