Imagine putting the final touches to a product you’ve been working on for months before realising you can’t actually sell it in your target market due to the lack of BIS Certification.
For many foreign manufacturers, the absence of required documentation can make the product ineligible for sale even if buyers and shipping arrangements have been finalized.
It is essential to note the mandatory requirements, such as a BIS licence and Standard Mark, for goods subject to a Quality Control Order (QCO) in the Indian market.
The Foreign Manufacturers Certification Scheme (FMCS), administered by the Bureau of Indian Standards (BIS), enables overseas manufacturers of goods that conform to Indian Standards to apply for a BIS licence. It was introduced in 2000 and administered under the BIS Act, 2016, and relevant conformity assessment procedures.
Being aware of the mandatory requirements of BIS FMCS Certification in India, such as a licence, helps avoid overseas manufacturers’ licensing, testing, financial, and supply chain complications.
What is BIS FMCS Certification?
The BIS FMCS Certification in India is a special conformity assessment scheme for manufacturers with production facilities outside the Republic of India.
Under this scheme, BIS grants a licence to overseas manufacturers to mark products that conform to the applicable Indian Standard with the Standard Mark. It typically applies to products apart from Electronics and IT Hardware under MeitY’s Compulsory Registration Scheme (CRS).
An overseas manufacturer is responsible for the application process for the BIS FMCS Licence and is not limited to submitting applications on behalf of an Indian buyer. Moreover, separate applications must be submitted for different Standards and manufacturing units under the same entity. As a result, it is essential to complete the BIS certification process before finalising the product’s manufacturing and delivery.
Who can apply for BIS FMCS Certification?
A foreign manufacturer whose production unit is not located in India can apply for BIS FMCS Certification, provided they can demonstrate compliance with the applicable Indian Standard.
As per the requirements set forth by BIS, the overseas manufacturer must have:
- Manufacturing infrastructure, machinery and equipment at the factory
- Testing infrastructure, equipment and arrangements to conduct product testing as per the Indian Standard
- Competent personnel for testing and inspection
- Provision to manufacture goods as per the Indian Standard
- Acceptance of the Scheme of Testing and Inspection (STI)
- Acceptance of licence terms and conditions
An overseas manufacturer must additionally nominate an Authorized Indian Representative (AIR).
What is an Authorized Indian Representative?
An Authorized Indian Representative (AIR) is one of the most crucial requirements for BIS FMCS Certification in India and must be nominated by the overseas manufacturer.
They are an Indian national appointed to support and facilitate compliance with the BIS Act, rules, regulations, and conditions of the licence.
The AIR could be an employee of the overseas manufacturer in India if they have a branch or office. The AIR must be legally appointed if there’s no branch or office in India in accordance with the requirements stipulated by BIS. Apart from being a point of contact for the overseas manufacturer, the AIR has responsibilities to BIS as well, such as facilitating liaison with the concerned manufacturer and managing market sample activities.
It is advisable to choose an AIR with experience in dealing with overseas manufacturers to ensure all processes are carried out smoothly.
Documents Required For BIS FMCS Certification
The documents required for BIS FMCS Certification in India mostly depend on the product category and associated Indian Standard. However, manufacturers must prepare the following documents:
- Basic information about the manufacturing unit and product category
- Test report furnished by a laboratory accredited by BIS/NABL as per the applicable Indian Standard
- Proof of ownership of the manufacturing plant (ownership deed, electricity bill, etc.)
- Trademark registration
- Licenses and registrations from relevant statutory bodies
- Design drawings or schematic of the product
- Installed capacity of the manufacturing unit
- Raw material data for manufacturing
- Specification and list of machines used for manufacturing
- Process flowchart for manufacturing
- Packaging type and process for packing
- List and details of testing equipment in the manufacturing unit
- Details of quality control personnel
- Process for removing defective or low-quality products
- Manufacturing unit map, and
- Organisational chart for the manufacturing unit
Additional documents for Foreign Manufacturers:
- Letter of authority for the Authorized Indian Representative (AIR)
- Documents about the overseas manufacturing unit, including layout plans, machinery, and Quality Control setup
- Undertaking as per the BIS format
Complete Process of BIS FMCS Certification in India
There are several steps involved in obtaining BIS FMCS Certification for foreign manufacturers:
Step 1: Application
The first step involves preparing the technical and legal documents, filling out the relevant BIS application forms, and submitting them along with the required fees.
The following activities fall under this stage:
- Preparation of documents and technical details
- Completion and submission of the BIS application for FMCS Certification
- Payment of government fees as applicable
- All applications are assigned an Application Number by BIS for tracking purposes.
- Preliminary Scrutiny of the Application by BIS
Step 2: BIS Query Handling
After preliminary scrutiny, BIS may raise queries pertaining to documents, technical details of the product, general information about the product or other applicable requirements.
The following activities fall under this stage:
- Review of queries raised by BIS
- Preparation of clarifications and documents
- Submission within the timelines specified by BIS
- Addressing any deficiencies identified by BIS
Step 3: Factory Inspection by BIS
Once all queries have been satisfactorily addressed, the next step is factory inspection by BIS to evaluate the infrastructure and systems in place at the overseas manufacturing facility. During the inspection, BIS officials review the following:
- Infrastructure and machinery at the manufacturing unit
- Production and manufacturing processes
- Quality control and quality assurance processes
- In-house testing infrastructure and equipment
- Availability of testing and inspection staff with appropriate competencies
- Compliance and inspection procedures
Step 4: Product Sample Testing
During factory inspection, BIS officials take samples of the products for testing purposes. The following activities fall under this stage:
- Sealing and labelling of samples during the factory visit by BIS
- Testing of products as per the applicable Indian Standard at the relevant BIS-recognised/accredited laboratory
- Evaluation of reports for conformance to the applicable Indian Standard
- Submission of reports for review by BIS
Step 5: Grant of Licence
If the product, manufacturing infrastructure, testing arrangements and documents meet the requirements stipulated by BIS, the application moves to this stage.
The following activities fall under this stage:
- BIS approval for licence grant
- Payment of licence and marking fees as applicable
- Completion of formalities for certification
- Grant of licence to use the BIS Standard Mark on the certified product
Step 6: Indemnity Bond & Performance Bank Guarantee
Prior to granting the licence, the overseas manufacturer must complete formalities related to the indemnity bond and performance bank guarantee as stipulated by BIS.
The following activities fall under this stage:
- Submission of the relevant indemnity bond through the AIR
- Submission of a Performance Bank Guarantee (PBG) of USD 10,000
- Completion of other formalities stipulated by BIS
- Issuance of BIS FMCS licence to the overseas manufacturer
Cost & Timeframe for BIS FMCS Certification
The cost of BIS FMCS Certification in India largely depends on the product category and the associated testing and inspection requirements.
| Particulars | Estimated Cost (Dollar) |
| Application Fees (BIS) | $12.00 |
| Per Diem Expenses for BIS Officers- 3 Days | $900.00 |
| Charges for the Visit | $466.66 |
| Contingency Funds | $111.11 |
| Bis Charges- Travel/Visa etc. -Estimate | $2,173.00 |
| Marking Fee (Min.) | $2,744.00 |
| Sample Testing | $400 to $3000 |
| Total Bis Cost | $6850.77 to $10000.77 |
BIS recommends that overseas manufacturers initiate the application process at 5 – 6 months prior to launching their products in India.
The overall timeframe largely depends on factors such as application deficiencies, response to queries, scheduling of factory inspections, transportation of samples for testing, testing schedules at testing labs, and payment of fees.
Common Challenges for Overseas Manufacturers
Some of the most common challenges faced by overseas manufacturers seeking BIS FMCS Certification in India are as follows:
- Selecting the wrong Indian Standard for their product
- Assuming that international test reports will be accepted by BIS
- Inadequate technical documentation for their product
- Lack of in-house test facilities and testing equipment
- Inadequate testing personnel for conducting product testing
- Incorrect product classification or variety selection
- Postponing the appointment of an AIR
- Inadequate preparation in anticipation of a factory inspection
- Delayed response to queries raised by BIS
- Underestimating costs involved in testing, travel and inspection
- Failure to plan for renewal of certifications in advance
- Trying to export products before obtaining BIS certification or licence
These challenges can lead to delays and increased costs for overseas manufacturers seeking to enter the Indian market. Also get to know more about BIS ISI Certificate for Indian Manufacturer.
Why Choose UMSPCS for BIS FMCS Certification?
Navigating the Indian regulatory framework can be overwhelming, especially for overseas manufacturers without local support. UMSPCS provides end-to-end regulatory consultancy services to manufacturers seeking BIS FMCS Certification in India.
UMSPCS has been supporting manufacturers to enter the Indian market from their overseas manufacturing setups for 6+ years, with experience across 600+ product compliance requirements, and can assist overseas manufacturers with the following:
- Product and Standard identification
- BIS applicability assessments
- FMCS Documentation support
- Technical file preparations
- Coordinating with AIR
- Application process management
- Response to queries raised by BIS
- Coordinating factory inspection preparations
- Testing laboratory support
- Documentation for licence grant
- Renewal and post-certification support
Our objective is to ensure manufacturers have an efficient and smooth journey to meeting regulatory requirements before their product launch in India by helping them avoid errors and documentation deficiencies associated with the process.
Conclusion
India has emerged as an attractive destination for international manufacturers, but it is essential to understand the intricacies of the local regulatory framework governing imports.
For manufacturers with overseas manufacturing units, ensuring BIS certification can become critical to their India strategy, especially if their product falls under the scope of a mandatory Quality Control Order (QCO).
The best way to deal with the requirements is to determine the Indian Standard for the product, evaluate the scope of BIS certification, identify requirements for testing and inspection, appoint an AIR, and apply for FMCS Certification well in advance of their intended product launch.
As an overseas manufacturer eyeing the Indian market, do not overlook the importance of BIS certification. Contact UMSPCS for assistance with BIS FMCS Certification in India and learn how we can help you meet the requirements before exporting your product.
Read more also: 10% BIS CRS Consultancy Discount This Raksha Bandhan 2026
FAQs
- What is BIS FMCS Certification in India?
BIS FMCS Certification is the BIS certification scheme through which overseas manufacturers can obtain a BIS licence for their products that conform to the applicable Indian Standards.
- Is BIS FMCS certification mandatory for all imported products?
No, BIS certification is generally voluntary but is mandatory for products covered by the applicable government Quality Control Orders or other mandatory certification requirements.
- Can an Indian importer apply for FMCS on behalf of a foreign manufacturer?
No, as per the provisions of the FMCS, overseas manufacturers must apply for BIS certification and cannot be represented by an Indian importer.
- Is an Authorized Indian Representative mandatory?
Yes, an overseas manufacturer must nominate an individual as the Authorized Indian Representative as per the requirements stipulated by BIS.
- Can one apply for FMCS certification for multiple manufacturing units with one application?
No, BIS requires separate applications to be made for different manufacturing units.
- How long is the validity of an overseas manufacturer’s licence?
The licence is initially valid for a period of not less than one year and up to two years, and renewals may be permitted for up to five years.
- Can a licensee add new product varieties after obtaining the licence?
Yes, the licensee may apply for additions to the licence for new product varieties, grades and types as applicable.
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