BIS FMCS CERTIFICATION – SCHEME I (ISI MARK SCHEME)

BIS Certification for Foreign Manufacturers

The BIS Foreign Manufacturers Certification Scheme (FMCS) is a certification scheme under which the Bureau of Indian Standards (BIS) grants a licence to foreign manufacturers to use the BIS Standard Mark (ISI Mark) on products that conform to the applicable Indian Standard(s).

FMCS operates under the BIS Act, 2016 and the BIS (Conformity Assessment) Regulations, 2018.

The scheme is applicable to eligible manufacturing units located outside India whose products are covered under the applicable compulsory certification requirements and relevant Indian Standards.

Under FMCS, BIS evaluates the manufacturer's production facilities, quality control system, manufacturing process, testing facilities and product conformity. This includes an on-site factory inspection by BIS officials at the overseas manufacturing premises.

For foreign manufacturers, the certification process also involves an Authorized Indian Representative (AIR) who acts as the Indian representative for communication and coordination with BIS, as applicable.

Why is BIS FMCS Certification Required?

Foreign manufacturers intending to manufacture, import or supply products in India that fall under a mandatory BIS certification requirement must obtain the applicable BIS licence before placing such products on the Indian market.

FMCS provides a structured mechanism through which BIS assesses the foreign manufacturing facility and verifies that the product and manufacturing controls comply with the applicable Indian Standard.

MCS Technology provides end-to-end BIS FMCS certification support for overseas manufacturers, from applicability assessment and documentation through factory inspection, testing, BIS coordination and licence grant.

MCS Technology – BIS FMCS Certification Services

Our FMCS support includes:

·        BIS certification applicability assessment

·        Identification of applicable Indian Standard(s)

·        Product and model evaluation

·        BIS application preparation and submission

·        Technical documentation support

·        Coordination with BIS-recognized laboratories

·        Factory inspection preparation and support

·        BIS auditor coordination

·        Sample collection and testing coordination

·        BIS query and clarification support

·        Authorized Indian Representative (AIR) coordination

·        BIS licence processing

·        Post-certification and licence maintenance support

·        Model inclusion and applicable scope-extension support

BIS FMCS Certification Process

The FMCS certification process generally involves the following stages:

1. Applicability & Standard Assessment

MCS Technology reviews the product, specifications, manufacturing process and intended Indian market application to determine the applicable BIS certification requirements and Indian Standard(s).

2. Documentation Preparation

All required technical, manufacturing, quality-control and statutory documents are compiled and reviewed before submission to BIS.

3. BIS Application Submission

The complete application is prepared and submitted to BIS along with the applicable supporting documents and prescribed fees.

4. Preliminary Scrutiny by BIS

BIS reviews the application and documents. Any observations or deficiencies identified during scrutiny are addressed before proceeding to the inspection stage.

5. BIS Factory Inspection / Preliminary Inspection

BIS officials conduct an on-site inspection of the foreign manufacturing facility.

The inspection generally covers:

·        Manufacturing process

·        Production facilities

·        Quality-control procedures

·        Raw materials

·        Manufacturing machinery

·        Testing facilities

·        Calibration of testing equipment

·        In-house testing arrangements

·        Quality-control records

·        Product conformity

·        Factory infrastructure and layout

6. Product Sample Collection & Testing

Samples are collected/submitted as required and tested at a BIS-recognized laboratory against the applicable Indian Standard.

MCS Technology coordinates the testing process and follows up with the laboratory until the required test report is completed.

7. Final Evaluation by BIS

BIS evaluates the application together with the factory inspection findings and applicable laboratory test results.

Any queries or observations raised by BIS are addressed during this stage.

8. Payment of Applicable BIS Fees

The applicable licence fee, advance minimum marking fee and other prescribed charges are paid as required under the applicable BIS requirements.

9. Execution of Required Legal Documents

The foreign manufacturer completes the required legal documentation, which may include the applicable agreement, undertaking / indemnity bond, performance bank guarantee and other documents prescribed under the FMCS requirements.

10. Grant of BIS Licence

After successful completion of the applicable technical, inspection, testing and documentation requirements, BIS grants the licence to the foreign manufacturer to use the BIS Standard Mark (ISI Mark) on the certified products, subject to the terms and conditions of the licence.

Documents Required for BIS FMCS Certification

The exact document requirement depends on the applicable Indian Standard and product category. The following documents are generally required:

Manufacturer / Factory Documents

·        Factory registration / business licence with English translation, where required

·        Factory name and complete address

·        ISO 9001 certificate, where applicable

·        Authorized signatory identification

·        Product manufacturing process flow chart

·        Manufacturing machinery list

·        Testing equipment list

·        Valid calibration certificates of testing equipment

·        In-house test reports / quality-control records

·        Factory layout

·        Raw material list

·        Product specifications and technical documents

·        Trademark / Brand Registration Certificate

·        Quality Assurance / Quality Control personnel qualification documents and photographs

·        Factory location / route map from the nearest international airport, where required

·        Details of manufacturing and testing facilities

·        Other documents prescribed for the applicable Indian Standard

Authorized Indian Representative (AIR)

A foreign manufacturer applying under FMCS is required to nominate an Authorized Indian Representative (AIR) in accordance with the applicable BIS requirements.

The AIR acts as the Indian point of contact between the foreign manufacturer and BIS and assists with regulatory communication, documentation and coordination.

AIR Documents / Information

The following information/documents may be required:

·        Indian company / office registration documents

·        Name of Authorized Indian Representative

·        Designation

·        Mobile / telephone number

·        Email address

·        Government-issued identification document, where applicable

·        Authorization / nomination documents as prescribed by BIS

MCS Technology can also assist foreign manufacturers with AIR coordination and related BIS documentation requirements.

BIS FMCS Certification Cost

The applicable BIS government fees and other certification expenses depend on the product, applicable Indian Standard, inspection requirements and testing requirements.

Performance Bank Guarantee

Where applicable under the FMCS requirements, the foreign manufacturer may be required to furnish a Performance Bank Guarantee in favour of the Bureau of Indian Standards.

The applicable amount and terms should be confirmed based on the current BIS requirements for the relevant product and application.

Estimated Timeline

The overall FMCS certification timeline depends on:

·        Product category

·        Applicable Indian Standard

·        Documentation readiness

·        BIS application scrutiny

·        Factory inspection scheduling

·        Laboratory testing

·        Resolution of BIS observations

·        Availability of the manufacturer and BIS officials for inspection

For a complete application with timely testing and inspection, the overall process generally takes approximately 2–4 months.

The above timeline is indicative and may vary depending on the product, BIS processing, laboratory schedule, factory inspection scheduling and other project-specific factors.

Products Covered Under BIS Scheme-I

BIS Scheme-I applies to products for which compulsory certification has been prescribed under the applicable Government / BIS notifications and orders.

The applicable product list and requirements may change from time to time.

Official BIS product coverage:
BIS – Products Under Compulsory Certification – Scheme I

Manufacturers should verify the latest applicable notification and Indian Standard before commencing the certification process.

Why Choose MCS Technology for BIS FMCS Certification?

MCS Technology provides end-to-end BIS certification assistance for foreign manufacturers entering or expanding in the Indian market.

Our Support Includes:

·        BIS applicability assessment

·        Indian Standard identification

·        Product and model evaluation

·        Technical documentation

·        BIS application preparation

·        BIS portal support

·        BIS-recognized laboratory coordination

·        Sample testing coordination

·        Factory audit preparation

·        BIS auditor coordination

·        AIR coordination

·        BIS query / clarification handling

·        Licence grant assistance

·        Model inclusion

·        Licence renewal and post-certification support

Start Your BIS FMCS Certification

Are you a foreign manufacturer planning to supply BIS-regulated products in India?

Share your product datasheet, applicable standard (if known), model list and factory details with MCS Technology. Our team can assess the BIS requirement and provide a certification roadmap, required documents, sample requirements, estimated timeline and commercial proposal.