Overview of FMCS BIS Certification

The FMCS is introduced as a program since 2000, by the Bureau of Indian Standards (BIS) and as per the provisions laid down in the BIS Act, 2016, with its associated Rules and Regulations. This scheme provides a FMCS BIS Certification to foreign manufacturers for using the Standard Mark (ISI mark) on their products that conform to respective Indian Standards in the interest of the Indian consumer with a guarantee of quality, safety, and reliability.

The scheme applies to all products other than Electronics and IT Goods, which are covered under the Compulsory Registration Scheme (CRS). Products have to be tested in laboratories recognized by BIS and the manufacturing facility of the manufacturers is to be inspected in order to obtain a license.

The manufacturers have to have a liaison or branch office in India for ease in correspondence and regulatory compliance. A license is set for a term of one year, which may be renewed at the end of the original period. The FMCS promotes international trade while ensuring compliance with necessary Indian quality requirements for foreign products.

Advantages of FMCS BIS Certification

• Market access: FMCS helps foreign manufacturers to sell their products in India if they comply with the required regulations; this allows them to access an ever-expanding market.
• Consumer Trust: The ISI Standard Mark assures Indian consumers of quality, safety, and compliance with Indian Standards, thus increasing the credibility of the brand.
• Regulatory Compliance: Manufacturers comply with Indian regulations so as to escape legal penalties or restrictions in importation of goods that are not compliant.
• Fair Competition: The certification process creates a level playing field between domestic manufacturers by measuring the quality of production against that of foreign manufacturers.
• Safety Assured: Certified products minimize risk factors, protecting consumers from low quality or unsafe products.
• Brand Recognition: With the ISI mark, the brand gets more reputation before the Indian consumer, thereby boosting preference and brand loyalty among Indian consumers.
• Facilitation: FMCS offers foreign manufacturers a simplified certification process through a dedicated framework and well-defined guidelines.
• Business Expansion: Trust is built with Indian buyers and distributors and long-term relationships developed, resulting in increased sales.
• Synchronicity with Global Compliance: Once BIS standards are followed, the products can better meet international quality benchmarks and find it easier to enter into other markets.
• Economic Integration: FMCS promotes international trade and strengthens economic ties between foreign manufacturers and India.

Requirements for FMCS BIS Certification

• The manufacturing facilities must be situated outside of India.
• The foreign manufacturer or company must agree to the terms and conditions of the license.
• An in-house laboratory equipped for product testing and quality control personnel must be available to ensure compliance with Indian Standards Specifications (ISS).
• It is essential to ensure that their products conform to the relevant Indian Standards Specifications.
• The manufacturer must accept the Scheme of Inspection and Testing (SIT) and pay the annual marking fee.
• All necessary manufacturing machinery and testing facilities must be present at the production units.

Documents Required for FMCS BIS Certification

• Company Registration & Licensing

a) Documentation for Factory or Company Registration

b) Business License

c) ISO Certification (with English translations if in another language)

• Manufacturing Process Documentation

a) Flowchart illustrating the Manufacturing Process

b) If relevant, drawings of the product or its components

• Testing & Quality Control

a) Test Reports in accordance with Indian Standards

b) Comprehensive list of test equipment and their calibration certificates

• Raw Materials Documentation

a) Inventory of raw materials

b) Raw Material Test Certificates

• Additional Documentation

a) Declaration and Undertaking

b) Nomination

c) Any additional certificates related to products for the factory system

Guidelines for Nominating an Authorized Indian Representative (AIR) by Foreign Manufacturers

Every foreign applicant or manufacturer is required to establish a branch office in India, which will be responsible for fulfilling all obligations and duties under the BIS Act, along with any associated rules and regulations pertaining to registration. To effectively present their case, adhere to registration criteria, and comply with regulatory standards, foreign manufacturers and companies must appoint an Authorized Indian Representative (AIR) within India.

If a foreign applicant lacks a branch office in India, it is essential to designate an AIR to secure an ISI Mark Certificate and a BIS License. The AIR serves as the local representative, responsible for submitting and managing the certification application, and is available to address any inquiries. When selecting an AIR, the applicant must ensure the following conditions are met:

• The nominee for AIR must be an Indian citizen.
• The AIR must agree to be accountable for complying with the terms and conditions outlined in the BIS license, as well as any agreements, undertakings, or other documents executed on behalf of the foreign manufacturer.
• An AIR may represent only one foreign manufacturer at any given time and is prohibited from acting on behalf of multiple foreign applicants.
• When AIRs evaluate a sample at a third-party laboratory, they must not have any conflicts of interest in their role as AIRs.
• The minimum qualification required for an AIR is a bachelor’s degree, along with a comprehensive understanding of the provisions of the BIS Act, 2016, and its associated rules and regulations.
• The name of the AIR must be included in the license documentation.

Procedure for getting FMCS BIS Certification

Step 1: Documentation and Submission: Initially, our specialists will gather all necessary documents. Subsequently, they will file the application and submit it online to BIS, accompanied by the required documents. A hard copy of the application will also be dispatched to the FMCD Department.

Step 2: Application Verification: Upon submission of the application to the BIS Authority, a verification process will ensue. Should any document, testing equipment, or other requirements be found lacking or incomplete, the BIS Authority will reach out via email. If the application meets all criteria, it will be officially recorded.

Step 3: Factory Premises Audit: An inspection will thereafter be organized by the BIS Officer of the applicant's factory premises on a date mutually agreed upon. Here officers will see the infrastructure, manufacturing processes, and test the product in the in-house laboratory. Besides, a sample of the product will be taken for independent laboratory testing.

Step 4: Testing of Sample: The sample collected shall be sent to a BIS-recognized laboratory only and the Testing charges shall be directly paid more by the applicant.

Step 5: The license will be issued if the inspectors of the BIS are satisfied with the inspection and the testing reports and where the prescribed fee for grant of license and the minimum marking fee have been paid.

Step 6: Indemnity Bond: In addition, the performance bond guarantees of $ 10,000 to BIS should be accompanied by an Indemnity Bond following the said issuance of the license. If Performance Bank Guarantee is not produced, BIS shall have the power to cancel such license on the spot.

Foreign Manufacturer Certificate Validity and Renewal

Initially, a license shall be granted for a term of between one and a maximum of two years, provided that, annually, the requisite license fee and advance minimum marking charge have been paid.

How Whizseed can help you?

• Help foreign manufacturers compile all required documents
• Guide manufacturers through each certification step
• Facilitate online application submission
• Ensure full compliance with BIS requirements
• Provides expert support during BIS Authority verification
• Simplified navigation of complex regulatory requirements
• Proven track record of successful certifications