Foreign Manufacturers Certification Scheme (FMCS)

FMCS stands for Foreign Manufacturers Certification Scheme, a specialized BIS product certification program designed exclusively for manufacturers located outside India who wish to sell products in the Indian market.

Who needs FMCS?

• Foreign manufacturers of products that fall under mandatory BIS certification requirements (such as steel products, electrical appliances, cement, cables, tyres, food products, and hundreds of other regulated goods).
• Exporters to India who do not have manufacturing facilities in India but need to comply with Indian technical regulations.
• International brands looking to establish market access in India through regulatory compliance.

Established in the year 2000, FMCS allows foreign manufacturers to obtain BIS licence through an on-site audit conducted at their manufacturing facility abroad. This certification is mandatory for identified products under Indian technical regulations aimed at protecting consumer health, safety, security, environment, and preventing deceptive trade practices.

If you manufacture products abroad and want to sell them in India, FMCS certification from BIS is likely required.

While both FMCS and regular BIS certification serve the same purpose — ensuring products meet Indian standards — there are key differences in the application process and requirements:

Regular BIS Certification (for Indian Manufacturers):

• Conducted for manufacturers with facilities located in India.
• BIS conducts on-site inspections at the Indian manufacturing unit.
• No requirement for an Authorized Indian Representative (AIR).

FMCS (for Foreign Manufacturers):

• Designed specifically for manufacturers located outside India.
• BIS conducts on-site audits at the foreign manufacturing facility.
• Requires appointment of an Authorized Indian Representative (AIR) — a legal entity in India responsible for liaison with BIS, handling documentation, coordinating testing, and ensuring ongoing compliance.
• Testing of samples must be conducted in BIS-recognized or NABL-accredited laboratories in India.
• Additional documentation and coordination required due to cross-border nature of the certification.

The core standards and compliance requirements remain the same, but FMCS involves additional procedural steps tailored to the needs of international manufacturers.

Omega QMS specializes in guiding foreign manufacturers through the FMCS process and also acts as an Authorized Indian Representative (AIR) when required.

The timeline for FMCS certification varies depending on product complexity, readiness of documentation, and BIS audit schedules. However, a typical FMCS certification process takes between 4 to 8 months from application submission to licence issuance.

Key Stages and Timelines:

1. Documentation Preparation and AIR Appointment (2-4 weeks): Gathering technical documents, appointing an Authorized Indian Representative, and preparing the application.
2. Application Filing with BIS (1-2 weeks): Submitting the complete application along with supporting documents to BIS.
3. BIS Review and Initial Scrutiny (4-6 weeks): BIS reviews the application for completeness and compliance with Indian standards. Any deficiencies or queries are raised at this stage.
4. Sample Testing in India (4-8 weeks): Samples are sent to BIS-recognized or NABL-accredited laboratories in India for testing against Indian standards. Testing duration depends on the product category and test complexity.
5. On-site Audit Scheduling and Execution (4-8 weeks): BIS schedules and conducts an on-site audit at the foreign manufacturing facility. The timeline depends on BIS audit schedules and travel logistics.
6. Audit Report Review and Licence Issuance (2-4 weeks): Post-audit, BIS reviews the findings, and if satisfactory, issues the BIS licence.

Factors that can accelerate the process:

• Complete and accurate documentation from the outset.
• Proactive audit preparation and readiness.
• Timely response to BIS queries and requests.
• Engaging an experienced consultant like Omega QMS to manage coordination and liaison with BIS.

Omega QMS expedites the FMCS process through meticulous documentation, audit preparation, and proactive coordination with BIS officials, ensuring minimal delays.

The cost of FMCS certification depends on several factors including product type, number of product models, testing requirements, and the scope of certification. However, typical costs can be broken down into the following components:

1. BIS Application and Licence Fees:

• Application fee: Payable to BIS at the time of application submission (typically ranges from INR 5,000 to INR 15,000 depending on the product).
• Licence fee: Annual licence fee payable to BIS after licence issuance (typically ranges from INR 10,000 to INR 50,000 annually depending on the product category and turnover).

2. Testing Charges:

• Laboratory testing fees: Cost of testing samples in BIS-recognized or NABL-accredited laboratories in India. Testing costs vary widely based on product complexity and number of tests required (can range from INR 20,000 to INR 2,00,000 or more).

3. BIS Audit Charges:

• On-site audit fees: BIS charges for conducting audits at the foreign manufacturing facility, including auditor travel, accommodation, and daily allowances. Costs typically range from USD 2,000 to USD 5,000 depending on location and audit duration.

4. Consultancy and AIR Fees:

• Professional consultancy fees: Fees charged by consultants like Omega QMS for documentation, application preparation, audit coordination, liaison with BIS, and ongoing compliance support (ranges from USD 1,500 to USD 5,000 depending on product and scope).
• Authorized Indian Representative (AIR) fees: Annual fees for acting as AIR (if Omega QMS is appointed as AIR), covering local liaison, documentation support, and compliance management.

5. Miscellaneous Costs:

• Sample shipment costs to India for testing.
• Translation of documents (if required).
• Additional testing in case of test failures or modifications.

Total estimated cost for FMCS certification: USD 5,000 to USD 15,000+ (excluding ongoing licence renewal and surveillance audit costs).

Omega QMS provides transparent, upfront cost estimates tailored to your specific product and requirements. Contact us for a detailed cost breakdown and proposal.

Email: info@globalomega.com | Phone: +91-9810047474

No, foreign manufacturers do not need to establish a physical office or manufacturing facility in India to obtain FMCS certification. However, BIS regulations require foreign manufacturers to appoint an Authorized Indian Representative (AIR) — a legal entity based in India — to act on their behalf.

Role of the Authorized Indian Representative (AIR):

• Acts as the local liaison between the foreign manufacturer and BIS for all certification-related matters.
• Handles documentation, correspondence, and communication with BIS on behalf of the manufacturer.
• Coordinates sample testing in Indian laboratories.
• Facilitates audit scheduling and preparation for BIS on-site audits at the foreign facility.
• Ensures ongoing compliance with BIS requirements, including surveillance audits, licence renewals, and submission of periodic reports.
• Provides a legal address in India for official correspondence and regulatory purposes.

You do not need to set up your own office. Instead, you can appoint a professional consultancy like Omega QMS to serve as your AIR. This eliminates the need for capital investment in infrastructure, hiring local staff, or navigating Indian regulatory processes independently.

Omega QMS acts as an Authorized Indian Representative (AIR) for foreign manufacturers, providing a complete turnkey solution for BIS FMCS certification and ongoing compliance management.

Yes, Omega QMS provides comprehensive Authorized Indian Representative (AIR) services for foreign manufacturers seeking FMCS certification. We have extensive experience acting as AIR for manufacturers across Asia (China, Taiwan, South Korea, Japan, Vietnam, Indonesia, Thailand, Nepal, Bangladesh), Europe (UK, Turkey, Austria, Germany, Greece), Iran, and the USA.

What We Offer as Your AIR:

• Complete documentation and application preparation: We prepare and file all required documents with BIS, ensuring accuracy and compliance.
• Liaison with BIS: We handle all communication and coordination with BIS officials on your behalf, eliminating language and time zone barriers.
• Testing coordination: We arrange sample collection, shipment to Indian laboratories, and testing against Indian standards.
• Audit preparation and support: We prepare your facility for BIS on-site audits, coordinate audit schedules, and provide guidance to ensure successful audit outcomes.
• Ongoing compliance management: We manage surveillance audits, licence renewals, and submission of mandatory reports to BIS.
• Legal address in India: We provide our registered office address for all official BIS correspondence and regulatory purposes.
• Client-based coordination: Where needed, we coordinate with your local office or importers in India to ensure seamless operations.

Industries We Serve:

We partner with major manufacturers of steel products, tyres, cement, electrical cables and appliances, food products, and hundreds of other regulated product categories.

Why choose Omega QMS as your AIR?

• Deep expertise in BIS FMCS certification and Indian regulatory environment.
• Proven track record with manufacturers from over 15 countries.
• Transparent pricing and clear service agreements.
• Proactive communication and dedicated support throughout the certification lifecycle.

Get started with Omega QMS as your trusted AIR partner. Contact us today for a confidential consultation.

Email: info@globalomega.com | Phone: +91-9810047474