BIS ISI Registration for Surgical masks | Fees, Documents & Procedure

Updated on August 04, 2025 12:54:58 PM

The Bureau of Indian Standards (BIS) is a government agency that oversees the quality, safety, and reliability of products and services in India. BIS offers a variety of quality certifications for different goods, one of which is for Surgical Masks. Manufacturers of Surgical Masks must obtain ISI registration to ensure that their products meet Indian regulations and standards that are equivalent to EU quality standards.

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 mark, which is a symbol of quality and safety. The ISI mark guarantees that the product has met all necessary standards and is a mark of trust and confidence for consumers. It also helps to build a strong brand image for the manufacturer.

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

BIS ISI Certificate Sample

BIS Registration certificate Sample
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What is BIS ISI Registration for Surgical Masks?

The Bureau of Indian Standards (BIS) gives ISI Registration Certificates to Surgical Masks. This certification confirms that the products 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 Masks. 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.

BIS certification ensures consumer confidence, promotes fair trade practices, and helps to improve quality in the Indian market.

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Documents required For BIS ISI Registration for Surgical Masks?

The following are the documents that must be submitted during the registration for a Surgical Masks:-

  • List of Raw materials used
  • Details of factory Location
  • Description of Manufacturing process
  • Details of Machinery
  • Plant Layout In Details
  • Inhouse lab for initial quality checkups
  • Test report by a BIS recognized Laboratory
  • Photograph of product
  • Undertaking
  • Application form

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

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Fees For BIS ISI Registration for Surgical Masks

Here are the fees for BIS ISI registration for surgical masks, given below.

Particulars Fee
Application Fee 1,000
Sample Test Fee As applicable
ISI Licensing Cost 1,000
Inspection Charge 7,000
Professional Fee Starts From 40,000

Note: The abovementioned fee is exclusive of GST.

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Benefits of BIS ISI Registration Certificate for Surgical Masks

Obtaining ISI registration can help you in the following ways:

  • Increase Brand Value and Customer Confidence: BIS registration is a mark of quality and safety. It shows that your Surgical Masks meet all the required standards and are safe to use. This can help you in increasing your brand value and gaining the confidence of your customers.
  • Reduce Risk of Product Recalls and Penalties: BIS ISI registration can help you in reducing the risk of product recalls and penalties. If your Surgical Masks are not registered with BIS, they can be recalled from the market, and you may be liable to pay penalties.
  • 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.
  • Improved Market Access: BIS ISI registration can help you in improving your market access. It shows that your Surgical Masks meet the required standards and are safe to use. This can help you in getting your Surgical Masks approved for sale in more markets.
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What is the validity of BIS ISI certification for Surgical Masks?

ISI BIS registration is valid for up to 1 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 Mask

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

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

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.

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.

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

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Setting up In-House lab for Surgical Masks

  • 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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Conclusion

ISI registration for Surgical Masks is mandatory to ensure the safety and quality of products available in the Indian market. Manufacturers who go through the certification process can provide consumers with reliable and high-quality Surgical Masks. Additionally, consumers can enjoy their favorite music and content without having to worry about safety issues. Therefore, the next time you buy Surgical Masks, be sure to look for the BIS standard mark, which assures peace of mind and a pleasant listening experience.

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Frequently Asked Questions

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 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 BIS 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.

  • Provide documents & Details
  • Filing and submission of fee
  • Issuance of certificate
Do importers of Surgical Masks need BIS certification?

The Ministry of Electronics and Information Technology (MeitY) has mandated that all importers of Surgical Masks and Surgical 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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