BIS Certificate For Mask

With covid-19 evolving under different circumstances and introducing different variants, the government considers it’s important for manufacturers or importers to obtain a BIS certificate for mask

As the cases of Covid-19 are surging, masks have become an essential part of our life, or we can safely say that masks are a necessity of your life, similar to food, water, clothes, and shelter.

We look at some statistics from contemporary or last year, we can see -

  • The Indian surgical mask market was valued at $71.73 million in 2019
  • It is expected to reach $157.13 million by 2027.
  • In 2019, India was manufacturing 3 lakh PPEs, and N95 masks per day.

Although the expectation to increase the production of masks raises a concern about the quality of masks, prioritizing the health of the public, a BIS certificate for masks has been made a mandatory requirement. 

Be it obtaining a BIS certificate for N95 mask, or other kinds of mask, not getting a BIS certificate for mask is not a requirement. Moreover, it is simply not about the BIS certification, but a BIS-certified product offers numerous benefits to a manufacturer or importer of a product, from elimination of imposition of a penalty to wider market access, a BIS certification needs to be obtained to increase the sales of your product.

To know more about what are the other benefits you can avail yourself of, move to the next section.

Which BIS Certification is Applicable on Mask?

The Bureau of Indian Standards (BIS) includes three different certification schemes, namely -

BIS Certificate For Mask

Let’s understand each scheme in detail -

Indian Standards Institute (ISI) is the certificate scheme under BIS (Bureau of Indian Standards) which confirms that a product withstands the BIS standards which ensures safety.

Foreign Manufacturers Certification Scheme (FMCS) as per the BIS Act, 2016 and Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, BIS has the authority to provide a license to the foreign manufacturer to sell products in the Indian market.

Compulsory Registration Scheme (CRS) under the Scheme-II of Schedule-II of BIS (Conformity Assessment) Regulations, 2018. Further, under this, a number of guidelines have also been formed.

Though all these certification schemes are not applicable to mask, only ISI and FMCS are two certification schemes application on the same. Thus, to build credibility and trustworthiness, you need to obtain ISI and FMCS BIS certification for N95 mask. 

If you are wondering, out of ISI and FMCS, which one you are required to obtain, then we would like to draw your attention to the following -

Now since both the certification scheme includes the same products, we would like to clarify that the products under the purview of ISI and FMCS are the same, the major difference lies in their certification process. The process of ISI certification is quite easy if compared to the process of FMCS because its certification process includes comprehensive activities such as traveling to the client’s destination country, delivering products to India, and more.

For a better understanding of the BIS certification process for mask, let’s move to the next section -

How to Get a BIS Certification For Mask | ISI and FMCS Certification Process

ISI Certification Process

BIS Certificate For Mask

  • The application form needs to be filled out.
  • Further,  a factory inspection will be conducted for the assessment of manufacturing infrastructure, production process, quality control, and testing capabilities.
  • During an inspection, a product sample will be drawn for testing in a third-party laboratory.
  • To review, the test report of the product sample will be used.
  • Finally, you can obtain the certificate, if your product complies with the laid standards.

FMCS Certification Process

BIS Certificate For Mask

  • The application form will be duly filled accompanied by the required documents.
  • Along with form submission, a requisite fee will be paid, then a factory inspection will be conducted to verify the manufacturing and testing infrastructure.
  • During factory inspection, the sample of a product will be drawn for independent testing.
  • Once the inspection and independent test report verify that the product is complying with the BIS standards, the registration process will move forward.
  • Before the grant of a license, the applicant has to pay the license fee, advance minimum marking fee.
  • After making payments, the Agreement, Indemnity Bond will be signed and a $10,000 (USD) Performance Bank Guarantee must be furnished instantly after a grant of license.
  • The FMCS certificate will be issued if a product complies with the BIS standards.

With the process of BIS certification for mask, it is clearly established that ISI and FMCS are different. Moreover, it is to be noted that ISI certification is an online process, while FMCS is an offline process, which further increases the complexities. 

However, JR Compliance - a leading compliance service provider makes it seamless through our expertise and professional approach. For more information regarding how we will make the procedure of BIS certification for N95 mask easy, let’s move to the next section -

How Will We Help the BIS Certification Process?

  • We will educate you concerning every aspect of the ISI and FMCS certificate.
  • We will check whether a product falls under the purview of BIS or not, including whether a product complies with the BIS standards or not, then, after mutual understanding, the project will move forward. 
  • Obtaining an ISI and FMCS certification is no easy task, however, there is no better place to obtain it than JR Compliance because we will analyze the product requirements to give clear guidelines.
  • JR Compliance has experienced BIS consultants, who can assist you in the documentation, evaluation, and examination.
  • We are equipped with the necessary resources to conduct a virtual pre-audit to confirm whether your manufacturing unit and production process are complying with BIS requirements or not. 
  • JR Compliance will schedule a meeting with the BIS officer for a factory audit.
  • If you lack an in-house testing facility, we will help you in setting up one.
  • We will coordinate with a BIS accredited laboratory for product testing.
  • As a leading compliance service provider, JR Compliance will assist you in the customs clearance of the sample products.
  • You can expect reliable and punctual service delivery as we will also visit the BIS office on your behalf if required.
  • We invest our sustained efforts to meet the startled queries or demands of BIS.
  • In case of any concern, we assure to provide the finest solution.


Hope you have what you are looking for regarding - BIS certification for mask, though, if you still have any doubt, why don’t get in touch with us right now for a FREE consultation.

We assure you that we are the #1 compliance services provider, not just for the sake of saying it, but our experience of over 8+ years and completed over 10,000 BIS projects of Indian and globally recognized brands such as Troy, Softbank, Bombay Dyeing, and more.

So, get in touch with us right now to meet your compliance requirements.