There exist plenty of business opportunities for foreign manufacturers in the Indian market. Nevertheless, entering the market of India is not just about identifying distributors and logistics or knowing the consumer needs. For certain regulated products, the manufacturers have to prove their compliance to the applicable Indian Standards and receive the appropriate approval from the Bureau of Indian Standards (BIS).
The foreign product might be certified to international standards or even possess certifications issued by the certification body of its country of origin. In any case, such foreign products should meet all the requirements of the applicable Indian Standard and be capable of passing the BIS Conformity Assessment Process.
The foreign manufacturers of eligible non-electronic products are allowed to apply to the Foreign Manufacturer Certification Scheme (FMCS). This allows the BIS to issue a license to use the Standard Mark on products that comply with the respective Indian Standard. The FMCS works in accordance with the Bureau of Indian Standards Act, 2016 and conformity assessment regulations.
This blog covers BIS Certification for Foreign Manufacturers in terms of eligibility, requirements, documents, procedure, benefits, validity period, timeframe and other aspects.
Understanding BIS Certification for Foreign Manufacturers
Foreign Manufacturer’s Certification Scheme (FMCS) is a BIS certification system for foreign manufacturers whose production plants are situated outside India.
As per FMCS, BIS is authorized to issue a licence to a foreign manufacturer if the products meet the requirements of the corresponding Indian Standard. Such a license will entitle the foreign manufacturer to affix the BIS Standard Mark, which is commonly called the ISI Mark, on the approved products.
It should be noted that the certification procedure may vary depending on the product group.
Most non-electronic products can be registered through FMCS. However, Electronics and Information Technology products declared by the Ministry of Electronics and Information Technology (MeitY) generally fall under the Compulsory Registration Scheme (CRS). That is why the foreign manufacturers of such products must obtain BIS CRS Certification for Electronic Products and not FMCS License.
Who Is Eligible to Apply for BIS Certification Under FMCS?
In order to qualify for BIS Certification of Foreign Manufacturers, one must be the manufacturer of the product and should possess a manufacturing facility based outside of India.
Following are the important eligibility criteria:
- Have a Manufacturing Unit Based Outside India
- Have a Product that Satisfies Indian Standards
- Maintain a Suitable Manufacturing Setup
- Facilities for Conducting Tests Should Be Available
- Qualified Quality Control Staff
- Adherence to BIS Requirements and Licence Terms
- An Authorised Indian Representative (AIR) Should Be Appointed
- Application Should be Done for Individual Products/ Factories
A Quick Eligibility Checklist for Foreign Manufacturers
Prior to applying, an international manufacturer should ensure that:
- The production plant is not in India
- The manufacturer is really the producer of the product
- The relevant Indian Standard has been determined
- The product is able to meet the applicable IS criteria
- Machinery required for manufacturing is available
- Testing facilities within the company have been set up
- Able personnel for quality control are available
- The eligible Authorized Indian Representative has been nominated
- The manufacturer is ready to be assessed at BIS’s factory visit
- The manufacturer is willing to abide by the applicable inspection and testing criteria
Legal Framework Governing BIS Certification
The regulatory system that governs BIS Certification for Foreign Manufacturers is mainly governed by:
- The Bureau of Indian Standards Act, 2016
- Bureau of Indian Standards Rules
- Bureau of Indian Standards (Conformity Assessment) Regulations, 2018
- Indian Standards
- Guidelines and manuals related to particular products
- Quality Control Orders (QCOs) if applicable
- Terms and conditions relating to the BIS licence
It is normally a voluntary process for a foreign company to get its products certified by the BIS; however, in some cases, when the Government of India makes it compulsory through a Quality Control Order or any other notification to have a product certified, then the certification becomes mandatory.
Documents Required for BIS Certification for Foreign Manufacturers
However, the exact documents may vary according to the product, Indian Standard, certification scheme and manufacturing set-up. But, some of the essential documents which the foreign manufacturer should be able to submit could include:
- Basic information regarding the manufacturing facility and the product group
- Report prepared by a laboratory accredited by BIS/NABL as per the Indian Standard
- Evidence of possession of the manufacturing facility (property papers, utility bills, etc.)
- Trademark registration
- License & approval obtained from statutory bodies
- Product design drawing/schematic
- Installed capacity for manufacturing
- Information regarding raw materials
- Spec & list of manufacturing machinery
- Flow chart of manufacturing process
- Type and process of packaging
- Test equipment list & calibration in the manufacturing facility
- Quality Control Personnel Information
- Procedure of disposal of inferior products
- Facility layout plan
- Factory organisational structure
BIS might ask for additional documents regarding the product under assessment.
Step-by-Step Process for BIS Certification Under FMCS
Step 1: Application Submission
The initial step includes the preparation of the requisite documents, submission of BIS application and scrutiny of the application by BIS.
The step includes:
- Preparation of the requisite documents
- Submission of BIS application
- Payment of applicable fees
- Creation of application number
- Scrutiny of the application by BIS
Step 2: Resolution of BIS Queries
BIS may issue queries for clarifications and provision of information/documents in case of any inadequacy of information after scrutiny of the application.
The step includes:
- Scrutiny of BIS observation
- Supply of further information/documents, if necessary
- Response to queries of BIS within specified time period
Step 3: Factory Inspection
On receipt of acceptance of the application, inspection of the overseas manufacturing facility is carried out by BIS officials.
During inspection, BIS will examine the following aspects:
- Manufacturing facility
- Process of manufacturing
- Quality control facility
- In-house testing facility
- Compliance with BIS requisites
Step 4: Product Sample Testing
Product samples are sampled and tested to confirm compliance with the Indian Standard during factory inspection.
The step includes:
- Collection & Sealing of product samples
- Testing in BIS recognized laboratory
- Submission of test reports to BIS
Step 5: Grant of BIS Licence
If the product fulfills all the Indian Standards requirements, BIS then moves on to issuing the license.
This process is made up of the following activities:
- Approval of the BIS License
- Pay of marking and licensing fees
- Permission to affix the ISI Mark to the licensed product
Step 6: Indemnity Bond and Performance Bank Guarantee
Before the issuance of the license, there are certain legal procedures that have to be completed by the foreign manufacturer.
These include the following:
- Submittal of the signed Indemnity Bond by the AIR
- Submittal of the Performance Bank Guarantee (PBG) amounting to USD 10,000 as per the BIS guidelines
Benefits of BIS Certification for Foreign Manufacturers
The acquisition of BIS certification in India could bring about several benefits for business compliance:
- Entry into the Indian Market
- Enhanced Market Confidence
- Compliance Assistance
- More Business Opportunities
- Quality Advantages
BIS Certificate for Foreign Manufacture Fee Structure and Timeline
The BIS Certificate for Foreign Manufacture Cost varies depending on the type of product, tests required, and inspection costs.
| 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 |
There isn’t any single set timeline applicable to all FMCS applications. It usually takes around 5 to 6 months. An appropriately filled-out application form would make the process faster; however, incomplete documentation, testing failure, lack of factory, or response delay may result in an extended process.
Foreign manufacturers need to start the process long before they plan to launch or import their products.
Validity and Renewal of the BIS Licence
In the BIS scheme for product certification, the initial licence can normally be issued for a period not exceeding two years depending on the requirements and payment of the required marking charges.
The licence is only valid for the specified product types and manufacturing facilities in the licence itself. Licences can only be extended by submission of the necessary documents and charges and by adherence to BIS rules. As per BIS guidelines, licences can be renewed for the periods allowed by the relevant rules.
Common Challenges Faced by Foreign Manufacturers
Foreign manufacturers face problems like:
- Incorrect Assessment of the Certification Scheme
- Differences Between International and Indian Standards
- Lack of Proper Factory Test Facilities
- Incomplete AIR Documents
- Incomplete Technical Documents
- Factory Inspection Preparedness
- Delay in Answering Queries From BIS
How UMSPCS Can Help Foreign Manufacturers
The BIS certification procedure can be technical standards, product specific criteria, factory checks, testing procedures, documents, and regulatory co-ordination. For foreign manufactures, handling such requirements from outside India will pose additional difficulties.
UMSPCS with expertise in 600+ product compliance requirements and over 6+ years of industry experience provides assistance to manufacturers to deal with Indian regulatory compliance in an organised and informed manner.
Our assistance may include:
- Identification of applicable product profile and certification route
- Identification of Indian Standards and IS codes applicable
- Identification of applicability of FMCS and CRS
- Compliance gap analysis
- Document preparation and application
- Co-ordination with Authorized Indian Representative
- Testing and laboratory co-ordination
- Factory Inspection readiness assistance
- Support in dealing with BIS queries and regulations
- Assistance in BIS License scope, validity and renewal
Be it assistance in BIS Certification for Foreign Manufacturers, BIS ISI Certification for Indian Manufacturers, BIS CRS Certification for Electronic Products or assistance in BIS CRS Certification in India, our team will assist you in identifying the compliance route.
Conclusion
Not just documentation, BIS Certification for foreign manufacturers is a complete process of conformity assessment which includes product, facility of manufacture, testing facilities, quality management systems and compliance readiness.
Compliance with the eligibility conditions is the first thing. Foreign manufacturers have to determine their correct certification path, ensure compliance with the relevant Indian standard, make necessary testing arrangements, appoint an authorized Indian representative and get ready for BIS assessment.
Well-thought plan can eliminate unnecessary time loss and help foreign manufacturers be prepared for entering the Indian market successfully.
Ready to introduce your products in India?
Call UMSPCS today for professional assistance in BIS Certification for Foreign Manufacturers.
Read more also: How Does BIS CRS Certification Help Electronics Manufacturers
FAQs
- Which entities can apply for the BIS Certification for Foreign Manufacturers?
BIS certification can be applied by foreign manufacturers having their manufacturing plant outside India, provided that they fulfill the relevant BIS requirements.
- Can the importer apply for FMCS certification?
No, the foreign manufacturer alone can apply for the same. Importers cannot apply on behalf of their foreign manufacturers.
- Does every foreign manufacturer need AIR?
Yes, all the foreign manufacturers require Authorized Indian Representatives (AIR).
- Do all the foreign manufacturers apply for FMCS?
No, only foreign manufacturers of notified electronic and IT products are required to have BIS CRS Certification for Electronic Products.
- Will BIS accept international test reports?
Not necessarily, because products must conform to the Indian Standards and requirements of the BIS.
- What is the duration of the FMCS certification process?
Time taken varies from case to case depending on the product, documents, testing, inspection and evaluation by the BIS.
- What is the validity of the BIS Licence?
Validity period of a BIS Licence may be two years and could be extended as per BIS requirements.
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