The fact that India’s import market is expanding presents a significant opportunity for manufacturers based overseas, but it does not mean that all one has to do to enter the Indian market is to ship products to an Indian importer. When a product is subject to mandatory BIS requirements, the foreign manufacturer must secure compliance before engaging in the manufacturing, importing, distributing, or selling of the product in India.
Non-electronic and non-IT products are primarily certified through the FMCS program, which is operated by the BIS. This means that the BIS will issue a license to manufacturers whose production conforms to the applicable Indian Standards.
But what does the foreign manufacturer need to do in 2026? Which documents are needed? Is it necessary to have an Indian representative? And how long will the certification process take?
The blog sets out the main requirements for Foreign Manufacturer Certification in India, together with the procedure, legal framework, validity, difficulties, and compliance issues that businesses intending to enter the Indian market should consider.
What Does Foreign Manufacturer Certification Entail in India?
In India, foreign manufacturer certification usually means getting the relevant BIS certification or registration that is required for products which are manufactured outside the country.
If a product is eligible under FMCS, the manufacturer can get a license from BIS to use the BIS Standard Mark on products meeting the particular Indian Standard.
According to the BIS, FMCS operates according to the BIS Act of 2016 and the BIS (Conformity Assessment) Regulations of 2018, and the license will be related to the products manufactured in specified manufacturing plants that conform to the appropriate Indian Standard.
Important 2026 Point
The BIS has transferred the submission of FMCS applications to an online format. The most recent BIS guidance states that hard-copy applications for FMCS were accepted up to 31 May 2026, after which applications are to be submitted via the Manakonline portal.
Is it Necessary for Every Foreign Manufacturer to Have BIS Certification?
The requirement will vary according to the product and the regulatory framework that applies to it; if the product is subject to a mandatory BIS certification requirement or Quality Control Order (QCO), the manufacturer must get the appropriate BIS approval before it is legally possible to supply the product in India.
The BIS states that the Central Government may place products within the scope of compulsory certification under the BIS Act or any other relevant legislation.
Therefore, before beginning an application, a foreign manufacturer should first determine:
- Applicable Indian Standard (IS)
- Whether the product is under mandatory certification
- Applicable QCO
- Appropriate BIS conformity assessment scheme
- Testing requirements
- Product varieties covered
- Manufacturing location requirements
- Applicable marking requirements
This assessment of BIS product compliance is generally the most important of the initial steps.
Who is eligible to apply for BIS certification as a foreign manufacturer?
A company that has a factory situated outside India may apply under FMCS, on the condition that the required conditions are fulfilled.
According to BIS, the foreign manufacturer must:
- Make the product at its own factory sites.
- Have the necessary manufacturing machinery and facilities.
- At the factory, there should be appropriate testing facilities and equipment.
- Have competent testing personnel.
- Make sure the product complies with the relevant Indian Standard.
- Accept the Scheme of Testing and Inspection (STI/SIT) requirements that apply.
- Agree to the BIS marking fee and licence terms and conditions.
An individual application must be made for each product/Indian Standard and for each manufacturing site, provided that the relevant BIS regulations are observed.
Documents Required for BIS FMCS Certification
The specific documentation required will vary according to the product and the relevant Indian Standard, but usually the foreign manufacturer should prepare:
- Basic data of the manufacturing unit and product category
- Test report furnished by a lab recognised by BIS/NABL as per the Indian Standard
- Evidence of ownership of the manufacturing plant (for example, a deed or a utility bill, etc.)
- Trademark registration
- Licenses and approvals from statutory authorities
- Product design drawings/schematic
- Installed capacity for manufacturing
- Data on raw materials
- Specification and list of manufacturing machines
- Flowchart for manufacturing process
- Packaging type and process
- List and calibration of test equipment available in the manufacturing unit
- Details of quality control staff
- Process of disposal of sub-standard products
- Map of the manufacturing unit
- Organogram of the factory
BIS also expects manufacturers to show they have enough manufacturing setup, process controls, quality control, and testing abilities.
How to Get BIS Certification for Foreign Manufacturers: Step-by-Step Process
The BIS FMCS Registration Process can broadly be understood through the following stages:
Step 1: Application Submission
Get the documents that are required, file the BIS application, pay the relevant fees, and have yourself subjected to a preliminary review by BIS.
Step 2: BIS Query Handling
BIS may ask about missing documents or other problems. The applicant must quickly give explanations or more documents.
Step 3: Factory Inspection
BIS inspects the overseas manufacturing facility to assess:
- Manufacturing infrastructure
- Production process
- Quality-control system
- In-house testing facilities
- Compliance procedures
Step 4: Product Sample Testing
The samples are chosen and sealed at the factory inspection and then tested at a laboratory which is recognised by BIS. The test reports are then sent to BIS.
Step 5: Grant of BIS Licence
Once the product has been properly assessed at the factory and tested, the applicant pays the relevant licence and marking fees, after which BIS grants the licence together with permission to use the applicable BIS Standard Mark/ISI Mark.
Step 6: Indemnity Bond & PBG
Before the licence is issued, the Authorised Indian Representative submits the Indemnity Bond together with a USD 10,000 Performance Bank Guarantee (PBG) where applicable.
Cost of BIS Certificate for Foreign Manufacture
The amount that foreign manufacturers have to pay for BIS Certification is not fixed and will depend on the product category, the applicable Indian Standard, the testing requirements, the factory inspection, the travel expenses, and the marking requirements.
Based on the applicable expenses, the estimated BIS-related cost may include:
| 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 |
Timeline for BIS Certification for Foreign Manufacturers
The BIS certification process for foreign manufacturers usually takes about 5 to 6 months, the length depending on the completeness of the documentation, the extent of BIS examination, the scheduling of the factory inspection, the product testing, and the timely settlement of any queries or non-conformities.
A delay could happen if the documents are incomplete, the samples fail testing, or corrective actions are needed. It therefore follows that preparing early will help to ensure that the certification process goes more smoothly and efficiently.
What Kind of Requirements Does a Foreign Manufacturer Have to Meet After Obtaining Certification?
Acquiring the licence does not mark the end of having to comply. A licensee of BIS must still:
- Manufacture conforming products.
- Adhere to the relevant testing and inspection requirements.
- Maintain quality-control systems.
- Apply the Standard Mark in accordance with BIS requirements.
- Maintain required records.
- Work with BIS inspections and surveillance.
- Supply the production or dispatch information when it is required.
- Ensure continued AIR compliance.
- Address non-conformities promptly.
The licence holder is still responsible for ensuring that goods bearing the Standard Mark comply with the requirements under the BIS Act. BIS has the authority to inspect products and to take samples in order to monitor compliance.
Benefits of BIS Certification for Foreign Manufacturers
Obtaining the appropriate BIS Licence for Foreign Manufacturers can help businesses:
- Ensure that compliance with regulations is achieved for the Indian market
- Show that you are in line with the Indian Standards
- Encourage Indian importers and buyers to feel more confident
- Support market entry that is in accordance with the law when certification is required
- Strengthen product credibility
- Provide structured access to the Indian market
- Ensure that a clear compliance framework is maintained to secure the continued supply
With products that are subject to mandatory certification, getting the required approval is not just a marketing benefit; it may in fact be a regulatory requirement. Read more also about BIS ISI Certificate for Indian Manufacturer.
What Makes UMSPCS the Choice for Foreign Manufacturer Certification in India?
UMSPCS provides overseas manufacturers, importers, and Indian businesses with assistance regarding product regulatory compliance and certification requirements.
UMSPCS, with more than six years of experience in the industry and having dealt with over 600 product compliance requirements, can help foreign manufacturers meet the Indian regulatory requirements through a structured compliance process.
Our support for BIS Certification for Foreign Manufacturers can include:
- Product eligibility assessment
- Indian Standard identification
- BIS scheme selection
- Documentation review
- AIR-related compliance support
- BIS application preparation
- Online application filing support
- Laboratory coordination
- Factory inspection preparation
- BIS query handling
Conclusion
For an overseas manufacturer, the first step in entering the Indian market is to understand the regulatory requirements of India.
A proper Foreign Manufacturer Certification India strategy should begin by identifying the relevant Indian Standard, checking whether BIS certification is required, choosing the correct conformity assessment route, preparing the factory and testing facilities, appointing a compliant AIR, and then finishing the BIS process before starting commercial supply where certification is in question.
In 2026, when FMCS applications are being submitted online via Manakonline, foreign manufacturers should make sure that their documentation and application process comply with the most recent BIS requirements.
Looking to get BIS Certification for foreign manufacturers in India?
Talk to UMSPCS now and have your product’s BIS applicability, the documentation requirements, and the certification pathway looked at before you start the application process.
Read more also: Sell Urological Medical Devices in India Without CDSCO Approval
FAQs
- Is it necessary for foreign manufacturers to have BIS certification?
It varies according to the product; in the case where the product is subject to mandatory BIS certification or a relevant QCO, BIS approval appropriate to the case is required prior to entering the market.
- What does FMCS mean in the context of BIS certification?
FMCS is the scheme for the certification of foreign manufacturers by which the BIS issues licences to eligible overseas manufacturers for products that comply with the relevant Indian Standards.
- Is it possible for a manufacturer from a foreign country to apply for BIS certification directly?
The foreign manufacturer is the applicant under FMCS, and an eligible Authorized Indian Representative is likewise required.
- Is it necessary to have an Authorized Indian Representative?
Yes, foreign manufacturers are required by the BIS regulations to appoint an AIR in order to operate the licence.
- Is it possible for an importer to apply for FMCS on behalf of the manufacturer?
The FAQ in the BIS FMCS document states that the foreign manufacturer should make the application under FMCS.
- Does the BIS carry out an inspection of a foreign manufacturer’s factory?
It is indeed essential that a factory assessment should form part of the FMCS licensing process, involving the verification of the manufacturing and testing facilities and also including sampling for testing.
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