The Foreign Manufacturers Certification Scheme (FMCS) is operated by the Bureau of Indian Standards (BIS) under Scheme-I of Schedule-II of the BIS Act, 2016 and the Conformity Assessment Regulations, 2018. Launched in 2000, the scheme allows foreign manufacturers to obtain the BIS Standard Mark, commonly known as the ISI Mark, to sell their products in the Indian market. The Foreign Manufacturers Certification Department (FMCD) is the sole authority responsible for granting BIS certificates to overseas manufacturers. The primary objective of the scheme is to ensure that Indian consumers receive safe, reliable, and high-quality products.

To obtain the BIS FMCS Certificate, the foreign manufacturing unit must undergo a factory audit to verify compliance with BIS standards. Additionally, it is mandatory for the applicant to appoint an Authorized Indian Representative (AIR). Upon successful certification, the product is marked with the ISI Mark, featuring a license number (CM/L-XXXXXXXXXX) and the relevant Indian Standard number, ensuring credibility and regulatory compliance.

Foreign manufacturers aiming to export their products to India must obtain a BIS Manufacturing Certificate under the Foreign Manufacturers Certification Scheme (FMCS). The following requirements must be fulfilled by the applicant:

1. The manufacturing unit must be located outside India.The product(s) must conform to the applicable Indian Standard Specification (ISS).
2. All necessary manufacturing machinery and testing facilities must be available at the factory premises.
3. An in-house laboratory with product testing equipment and qualified quality control personnel must be available.
4. The manufacturer must accept the Scheme of Inspection & Testing (SIT) and agree to pay the annual marking fee. 
5. The manufacturer must agree to the terms and conditions of the Licence.

Note: A separate application is required for each product and factory location.

The FMCS BIS Certification process requires a set of essential documents to be submitted through the BIS Online Application System. This digital platform ensures efficient record-keeping and faster processing. Before initiating the application, the applicant must be ready with the following documents:

Factory/Company registration documents

Detailed flow chart of the manufacturing process

1. Information on manufacturing capabilities, including in-house setup and any outsourcing agreements (if applicable).
2. Details of adequate in-house testing facilities.
3. Quality control parameters and their maintenance records.
4. Acceptance of the Scheme of Testing & Inspection (SIT) and the Annual Marking Fee.
5. Product testing report from an in-house laboratory or BIS-recognized lab.
6. Any other relevant technical information as per BIS norms.

Note: The complete and detailed list of required documents can be obtained directly from the Bureau of Indian Standards (BIS).

FMCS BIS certification process involves following systematic steps which will help in Grant of FMCS licence to foreign manufacturers.

FMCS ISI Mark Certification Process

1. Submit Application:

• Compile all required documents.
• Submit the application online via the BIS portal and send a hard copy to the FMCD department.
• BIS will verify the application and documents submitted.

2. Query Raised (if any):

• If any document, equipment, or requirement is missing or incomplete, BIS will communicate with the applicant via email.
• Once the application is found complete, an acknowledgment number will be issued for future reference.

3. Audit/Inspection:

• A BIS officer will schedule a factory visit on a mutually agreed date.
• The applicant must pay the inspection/audit fee.
• The BIS officer will inspect the manufacturing process, testing infrastructure, and verify in-house product testing.
• Product samples will be collected, sealed, and sent to an independent BIS-recognized laboratory.

4. Sample Testing:

• Samples are tested in a BIS-approved lab.
• Test charges are borne by the applicant.
• The test report is submitted to BIS for review.

5. Grant of Licence:

• If inspection and test reports are satisfactory as per Indian Standards, the applicant must pay the licence fee, advance marking fee, and clear any dues.
• BIS will issue the Letter for Grant of Licence.

An Agreement & Indemnity Bond is entered between the applicant and the Bureau of Indian Standards (BIS). It includes the following provisions:

• Fees
• Nomination
• All rights and responsibilities of licensee
• Indemnity
• Termination
• Performance Bank Guarantee
• Cancellation of License
• Non-Renewal

After successfully completing all the above steps and payment of applicable fees, the BIS licence will be granted. Initially, the licence is valid for 1 year and is renewable for subsequent years.

Note: A Performance Bank Guarantee of USD 10,000 from any bank approved by the Reserve Bank of India (RBI) must be submitted.

Timeline for BIS Licence

The average time for the Grant of Licence is approximately 6 months from the date of receipt of the complete application and its recording. However, the timeline may vary depending on circumstances such as:

• Delay in applicant's response to queries
• Delay in organizing inspection or testing
• Delay in remittance of applicable dues

Surveillance Inspection

Surveillance inspections are conducted by BIS from time to time. Market samples are drawn to assess the performance of the foreign BIS licensee.

Complaint Redressal

If any complaint is received against the licensee's product, an investigation will be conducted in accordance with IS/ISO 10002. Prompt action, such as free replacement or repair, will be taken. In case of any damage, the entire liability will rest with the licensee. BIS is not responsible for any losses or damages.

How to Renew BIS Licence?

A BIS Certified Manufacturer’s Licence is valid for 1 year. It can be renewed annually by submitting a renewal application along with the prescribed fees. The renewal form should be duly certified by a Chartered Accountant.

Every foreign applicant/manufacturer must have a branch office in India or appoint an Authorized Indian Representative (AIR) to fulfill all liabilities and obligations under the BIS Act, 1986 and its rules and regulations. The AIR represents the foreign manufacturer in all certification and registration matters with BIS.

In case a foreign manufacturer does not have a branch office in India, it is mandatory to nominate an AIR to obtain the BIS Licence or ISI Mark Certificate. The AIR is responsible for handling the application, communication, and compliance processes.

Eligibility and Responsibilities of AIR

• The AIR must be an Indian resident.
• The AIR must provide written consent to take responsibility for compliance with the BIS Act, rules, regulations, licence conditions, and any agreements or undertakings.
• An AIR can represent only one foreign manufacturer at a time and cannot act on behalf of multiple foreign applicants.
• The AIR must not have any conflict of interest, particularly in relation to sample testing by third-party laboratories.
• The AIR must hold a minimum of a bachelor’s degree and possess knowledge of the BIS Act, 2016 and relevant regulations.
• The AIR’s name will be mentioned in the licence documents.

The BIS certification process can be complex and time-consuming. To ensure a smooth and efficient experience, it is highly recommended to consult a professional agency.

Aleph INDIA Group, a leading FMCS consultancy firm, offers expert services for foreign manufacturers. With over 16 years of experience, Aleph INDIA ensures seamless certification and compliance support, helping businesses successfully enter and operate in the Indian market.