BIS FMCS Registration
BIS FMCS registration refers to the licensing scheme that enables foreign applicants to sell their products in India. The Bureau of Indian Standard i.e. BIS manages this registration within the purview of the Scheme-I of Schedule-II, BIS Act, 2016 as well as (Conformity Assessment) Regulations, 2018.
This scheme cum license is a doorway to the Indian marketplace for foreign manufacturers operating abroad. It allows them to use the ISI marking on their products and sell them in the Indian market. Overseas applicants can apply for this approval either themselves or via a certified agent. Choosing the latter option shall attract certain legalities, including filing a prescribed application for intimating authority about the agent. Let’s delve into the FMCS certification and its legalities.
Which department grants the BIS FMCS registration?
Notably, FMCS approval is granted by the specific BIS department, known as the Foreign Manufacturers Certification Department (FMCD). Even though overseas products are considered to be of utmost quality, adhering to the BIS guidelines is still mandatory for them before making their way out into the Indian marketplace. The scheme also covers foreign applicants running a facility overseas and willing to sell their product in India.
Underscoring requirements for securing BIS FMCS registration
BIS FMCS revolves around plenty of legalities, as given below, based on which the registration is granted.
- FMCS approval spans those manufacturing units that are operating outside India.
- Overseas products must adhere to the guidelines of the applicable Indian Standard.
- The facility must be equipped with relevant operational resources and machinery for production.
- The facility must have required testing equipment and quality control staff qualified to perform tests cited in the Indian Standard.
- The manufacturer must have a Scheme of Inspection & Testing(SIT), a legal document required to showcase control over the production process exercised by the owner. The documents should be added to the product manual granted by the BIS.
Note – One FMCS approval cannot regulate two entities or products. Therefore, for every new location or product, the applicant must apply separate application.
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Listicle of Mandatory Enclosures to BIS FMCS registration
The applicant seeking BIS FMCS registration should keep the following documents handy before delving into the registration process:
- Company registration documents for the factory
- Flow chart outlining the manufacturing process
- In-house manufacturing capabilities and outsourcing agreements, if applicable
- Testing facilities and equipment
- Quality control parameters and records
- Legal documents including Scheme of Testing & Inspection and annual marking fee
- Laboratory product testing reports from certified labs, demonstrating adherence to relevant standards (IS)
How to secure BIS FMCS registration: A 6 Steps Guide
The following steps will let you address the formalities concerning FMCS registration:
Step 1: Submit Application:
The first step requires compiling the required enclosures, furnishing the application to BIS online, and sending hard copy of the application to the FMCD department. Upon receiving the application, the BIS shall initiate the inspection process wherein documents are being inspected for accuracy and legitimacy.
Step 2: Resolve query (if any):
If the authority finds any document irrelevant or missing, they will inform the applicant via email. The applicant must respond in a timely manner to resolve the raised concerns quickly.
Step 3: Acknowledgement and Verification
If the applicant’s response is found to be satisfactory, the authority shall generate the acknowledgement number, which will help with application tracking.
Step 4: On-site Audit/Inspection
Subsequently, a BIS Officer will visit the production unit on the mutually agreed date. During this visit, the remittance of the audit fee shall be done, and BIS officials vet the facility and testing capabilities for compliance. Additionally, some product samples shall also be picked and then sent to the certified lab for testing.
Step 5: Sample Testing:
The collected samples shall undergo testing at the BIS-approved lab. After testing, the test report is generated and a fee is paid by the applicant. The report will then send to the BIS for review, affirming whether or not the product adheres to the required standard.
Step 6: Grant of Licence:
If the BIS finds the test report satisfactory and in line with the required standards, the applicant needs to bear some expenses in the form of fees, which include;
- Licence fee,
- Advance minimum Marking fee,
- Outstanding dues.
Once all payments are settled, the BIS grants the certification to the applicant, marking the end of the registration process.
Understanding the role of the AIR in securing the FMCS license
Foreign manufacturers seeking BIS FMCS approval without a branch office in India must appoint an Authorized Indian Representative (AIR), a local representative who addresses licence formalities on behalf of the applicant. While appointing such an individual, you must take several considerations into account, including;
Firstly, the AIR should be Indian and ensure adherence to BIS norms and licensing requirements. In addition to that, the AIR can only address a single applicant at a time to avert a conflict of interest. Furthermore, the AIR have no dispute with certified labs carrying out tests to ensure compliance.
Academic-wise, the AIR must be graduated and should be well-versed in BIS norms and relevant Indian Standards. Finally, the AIR’s name should be reflected in license documents.
Conclusion
BIS FMCS registration is of paramount importance for overseas manufacturers seeking ISI marking and market access in India. Since this registration revolves around a myriad of regulatory requirements, you must acquire adequate knowledge about your products and their regulatory aspects.
That why is we recommend proceeding with caution and under expert supervision. Adviso has been serving the regulatory realm for years. We have helped secure hundreds of BIS approvals for our clients despite overwhelming regulations and rigorous inspection. If you are not ready to embrace regulatory challenges, let us be your compliance partner.
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