How to Simplify the BIS FMCS Certification Process for Your Business?

Entering the Indian market provides substantial openings for overseas manufacturers, but the process quickly gets mired down unless adequate thought is paid to the correct Indian Standard, testing specifications, required documentation, factory inspections, and BIS processing procedures. This is exactly where the BIS FMCS Certification Process plays a part.

The BIS Foreign Manufacturers Certification Scheme, referred to as FMCS, offers an online business mechanism, providing Indian manufacturing standards and allowing overseas companies to gain access to a BIS license they can add a product with an applicable Indian Standard designation. The Bureau of Indian Standards, or BIS, notes on its site that the Bureau of Indian Standards (BIS) operates under the BIS Act, 2016, and the BIS (Conformity Assessment) Regulations, 2018.

But certification can be relatively simple if the business is approached properly; companies can make this process much more streamlined and dependable through appropriate product evaluation and product examination.

What is BIS FMCS Certification?

BIS FMCS Certification is specially developed for manufacturers who are manufacturing units in countries other than India. The scheme is for BIS to evaluate the product, manufacturing facilities, quality control, and testing of the foreign manufacturer to see if they fulfill the needs of the Indian Standard.

The Foreign Manufacturers Certification Department (FMCD), Headquarters, BIS, grants this licence. Generally, products other than Electronics & IT products notified under the applicable MeitY framework, for which BIS has introduced the Compulsory Registration Scheme (CRS), are covered under the FMCS.

Importantly, the BIS certification is not compulsory for all the products that are imported. If the Government of India has made BIS certification compulsory by giving a Quality Control Order (QCO) or any applicable regulatory requirement, it is not possible to import or sell the product without complying with the requirements of the BIS.

Who Needs BIS FMCS Certification?

If a factory of a foreign manufacturer is outside of India, and its product is in compliance with an applicable Indian Standard, then it can apply for FMCS.

BIS will demand that the manufacturer:

• Ensure conforming to applicable Indian Standard Specification (ISS)
• Possess the necessary manufacturing equipment and facilities in the factory
• Keep the correct testing facilities and equipment in the manufacturing facilities
• Ensure that competent staff with the ability to carry out necessary tests
• Please accept the applicable Scheme of Testing and Inspection (SIT) and marking fee
• Take into account the conditions and terms of the BIS licence

Correct scope planning is especially important as there are separate applications for each product Standard as well as for each manufacturing location.

The Legal Framework Behind FMCS

Knowing the regulatory background makes the certification process easier to handle.

The big framework is made up of:

In addition, BIS offers manuals and product-specific guidelines which can assist with an understanding of the expectations for infrastructure, testing, inspection and sampling.

Step-by-Step Process of BIS FMCS Certification

To simplify the process, it’s important to understand that it is not about bypassing regulatory steps. It’s about meticulous preparation of each step before proceeding to the next.

Step 1: Application Submission

The BIS FMCS Certification Process begins by preparing the required documents, filling the prescribed BIS application, and paying the relevant government fees.

Usually, this may involve the following sub-steps:

• Preparation of the required technical and legal documents
• Filling and submitting the BIS application form
• Payment of the application fees
• Receiving the BIS application number
• The initial scrutiny of the BIS application form by BIS

Step 2: BIS Query Handling

Upon submission, the BIS reviews the submitted application and may raise queries on the queries if there is a lack of information. The applicant must duly reply to the BIS queries and submit the requested clarification within the prescribed timeline, to avoid delay.

Step 3: Factory Inspection and Audit

A foreign manufacturing site visit and inspection will be done by BIS authorities to determine whether the manufacturer has the required infrastructure and quality system for manufacturing goods conforming to Indian Standards applicable to the product.

During the Factory visit:

• Manufacturing infrastructure and machinery present will be inspected
• Production and manufacturing process will be checked
• Quality Control systems will be audited
• In-house laboratory facilities and equipment will be checked
• Applicable compliance procedures are followed or not

Step 4: Product Sample Testing

Product samples shall be taken during the factory inspection and sent to the BIS-designated laboratories to check conformity against applicable Indian Standards.

This typically includes:

• Selection, sealing and sampling of the product samples
• Testing of samples through the stipulated BIS-Recognized Laboratory
• Evaluation and acceptance of test reports by BIS

Step 5: Grant of BIS Licence

Once all products, manufacturing and test results conform to applicable BIS requirements, then it can proceed further to a licence grant.

The general steps involved in this procedure:

• BIS approval for the grant of licence
• Payment of the licence fee and marking fees
• Grant for marking the certified products with the ISI mark subject to licence conditions

Step 6: Indemnity Bond & Performance Bank Guarantee

As a condition for grant of FMCS license, foreign manufacturers must complete certain financial and legal formalities before issuance of the BIS licence.

Usually, this may involve:

• Submission of an Indemnity Bond by the AIR
• Submission of applicable Performance Bank Guarantee(PBG) by the manufacturer as per BIS regulations
• Filling and completion of the remaining documentation and compliance formalities for the BIS licence to be issued finally

Documents Usually Required for BIS FMCS Certification

The set of documents may vary depending on the product type and standard; however, foreign manufacturers should be prepared to offer information regarding:

• Basic details about the manufacturing unit and type of products manufactured
• Test report furnished from an Indian Government-recognised laboratory / NABL-accredited laboratory
• Ownership proof of the manufacturing plant
• Trademark Registration
• Various Licenses and approvals from statutory authorities
• Product drawings
• Installed manufacturing capacity
• Raw material details
• List of manufacturing machineries and their specifications
• Manufacturing process flow chart
• Type and description of packing
• List and calibration of test equipment available in manufacturing premises
• Names of quality control personnel
• Standard product disposal processes
• Layout of the manufacturing plant
• Factory organizational charts

Additional Documents for foreign manufacturers:

• Appointment letter for Authorized Indian Representative (AIR)
• Overseas factory layout and machines and Quality Control arrangement documents
• Undertaking and Affidavits as per BIS formats

A product-specific list would be more effective than a generic one as norms can differ

BIS Certificate for Foreign Manufacture Fee Structure and Timeline

Cost of BIS Certification for Foreign Manufacturers varies based on the testing required, product class, and inspection costs.

Generally, the time frame required is 5 to 6 months depending on documentation, inspection, testing, and BIS query resolution.

Common Problems faced by foreign manufacturers

• Incorrect IS Code identified
• Incomplete documentation submitted
• Manufacturing site not prepared for inspection
• Non-conformity in testing of the products
• Compliance related to the Authorized Indian Representative (AIR)
• Delay in response to the BIS queries and clarifications

How a BIS FMCS Certification Consultant Can Simplify the Process

A professional BIS FMCS Certification consultant will guide the foreign manufacturer through each part of the certification, starting from identifying the applicable standard to licence grant.

A consultant will:

• Identify the applicable standard for the product along with relevant IS code
• Assess feasibility and applicability of BIS standards for the product
• Evaluate readiness of manufacturing site
• Prepare documents required for application
• Coordinate the application submission, testing, and inspection
• Help manage and respond to queries raised by BIS, both at application and technical level
• Manage product sample testing process
• Facilitate the grant of BIS licence
• Assist the manufacturer with ongoing renewal and post-certification compliances

Our aim is not only the application submission but to facilitate the organized, compliant journey for the foreign manufacturers through FMSC Certification.

Why Choose UMSPCS for BIS FMCS Certification?

At UMSPCS, we understand the need for support in navigating Indian regulatory requirements for foreign manufacturers located outside India.

With extensive experience in compliance for over 600+ products for 6+ years, UMSPCS helps international manufacturers meet the specific requirements of BIS FMCS Certification in India.

Our support can include:

• Product specification analysis and BIS requirement verification
• IS code identification and feasibility check
• Documentation compilation and submission
• Testing arrangement and supervision
• Inspection coordination for foreign manufacturers
• Handling BIS queries and deficiencies efficiently
• Authorized Indian Representative (AIR) coordination support
• Logistics and communication management with BIS
• License grant and post-compliance support

UMSPCS focuses on reducing potential compliance gaps, thereby ensuring a confident entry into Indian markets. BIS ISI Mark Consultant.

Conclusion

For eligible foreign manufacturers whose products are expected to comply with certain Indian Standards and regulatory requirements, obtaining BIS FMCS Certification in India is a critical milestone. 

From identifying the correct IS Code to preparing the manufacturing unit, assigning an AIR, carrying out testing, meeting the BIS factory inspection, and finally achieving the license, each step needs efficient and synchronized management.

Planning to implement BIS Certification for your overseas manufacturing unit? 

Connect with UMSPCS today for best-in-class assistance for product evaluation, documentation, testing, application submission, and certification support.

Read more also: DPIIT Notifies BIS Certification for Aluminium Cans for Beverages

FAQs

1. What is BIS FMCS Certification?

BIS FMCS Certification is a scheme under which foreign manufacturers are permitted to use the BIS Standard Mark on products conforming to pertinent Indian Standards.

2. Who is authorized to apply for BIS FMCS Certification?

FMCS licensing is open to any manufacturer with the factory and premises outside of India, meeting the specified quality requirements for manufacturing, testing, and the conformity aspect.

3. Do I need an Authorized Indian Representative (AIR)?

Yes, the nominated authorized representative from India (AIR) is required to act on behalf of the foreign manufacturer as per guidelines defined by BIS.

4. Can the FMCS application be submitted by an importer on behalf of the foreign manufacturer?

No, the foreign manufacturer is required to apply for the licence under the FMCS, as stipulated by BIS.

5. How long will it take to obtain BIS FMCS Certification?

BIS reports the average duration to acquire the FMCS certification to be about six months. However, the overall timeline may vary depending on the completeness of the application, factory inspection, and other issues.

6. Is a factory inspection carried out for FMCS?

Yes, a site visit will be made by the BIS representative, where he will assess manufacturing and testing facilities at the manufacturer’s site and draw product samples for independent laboratory testing.

7. What is the validity period of BIS FMCS Licence?

The license may be initially granted for a period up to two years, which is Renewable as per given norms and conditions and a stipulated performance evaluation.