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BIS certification for foreign manufacturer in India - Form V


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    CliniExpert-usp test license

    Are you a foreign manufacturer or importer looking to enter the Indian market and establish a strong presence? Look no further! CliniExperts understand the significance of BIS ISI Mark certification for foreign manufacturers/importers like you, and we're here to unlock the doors to success in the Indian market.

    BIS CERTIFICATION FOR FOREIGN MANUFACTURER (ISI MARK) – Overview

    The regulatory body to provide the certification scheme to foreign manufacturers for products excluding electronics and information technology is the Bureau of Indian Standards (BIS).
    • The manufacturer has to fill the application form along with the required documents.
    • As per the nomination form, the manufacturer has to nominate an Authorized Indian Representative (AIR).
    • The filled-in application form, along with the nomination form of Authorized Indian Representative (AIR) and requisite fee must be submitted at the Foreign Manufacturers Certification Department (FMCD) in the Bureau of Indian Standards (BIS) headquarters in New Delhi.
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    Who Can Apply?

    Manufacturers who have their manufacturing facility located outside India can apply under the Foreign Manufacturers Certification Scheme (FMCS). The manufactured products must conform to the Indian Standard Specifications (ISS) which is mandatory for obtaining the certification.

    How To Apply?

    The Applicant must follow the following process:

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      The application form must be made in the formats available under the Foreign Manufacturers Certification Scheme (FMCS) along with all the required documents.

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      The application will then be recorded upon receipt of application along with the requisite fee.

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      The Bureau of Indian Standards (BIS) will scrutinize the application and queries, if any, will be communicated to the manufacturer via email.

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      The Bureau of Indian Standards (BIS) personnel will then pay a visit to the location of the manufacturing facility to conduct verification of manufacturing and testing of infrastructure.

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      After acknowledgement of a satisfactory inspection report and independent test report(s) which conform to the Indian Standard Specifications (ISS), the license will be granted.

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    Validity

    The validity of the license is up to 2 years which can then be renewed for up to 5 years

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    Fee Involved

    • Application Fee ₹ 1000/-
    • Annual License Fee ₹ 1000/-
    • Special Visit Charges ₹ 7000/- per man-day
    • Testing Charges As applicable
    • Marking fee As applicable

    Important Documents

    Important Documents
    • The filled-in application form.
    • Documents authenticating the establishment of the branch/liaison office of the applicant/agent appointed by the applicant in India
    • Such documents include registration certificate with respect to the incorporated company, partnership deed with respect to the firm etc.
    • Such documents must include permission from the Reserve Bank of India (RBI), if applicable.

    Timeline to get Grant of License from Bureau of Indian Standards

    6 to 7

    MONTHS

    Essential Tips

    The essential processes which must be done for obtaining the license for products excluding electronics and information technology under the Foreign Manufacturer Certification Scheme (FMCS) are:

     
    • All manufacturing facilities must be present at the manufacturing factory.
    • The manufacturer must accept the Scheme of Testing & Inspection (SIT) and the marking fee.
    • All equipment for testing must be present at the manufacturing factory as per the Indian Standard Specifications (ISS).
    Expert Advise

    All manufacturing and testing facilities must be present at the manufacturing factory premises.

    English translations of all valid documents must be provided.

    The manufacturer must check the marking fee for the applicable Indian Standard Specifications (ISS).

    Frequently Asked Questions

    For test reports, can standards other than the Indian Standard Specifications (ISS) be accepted?

    No, the test reports will only be accepted as per the Indian Standard Specifications (ISS).

    Can product samples drawn during inspection be tested in laboratories approved by the International Laboratory Accreditation Cooperation (ILAC)/Asia Pacific Laboratory Accreditation Cooperation (APLAC)/government-owned laboratories in the country of the manufacturer?

    No, product samples drawn out during inspection must only be tested in laboratories approved by the Bureau of Indian Standards (BIS). The applicant must send the product samples drawn by the Bureau of Indian Standards (BIS) to the laboratory. The product testing charges must be borne by the applicant.

    Is nomination of the Authorized Indian Representative (AIR) mandatory?

    Yes, the foreign manufacturer must nominate an Authorized Indian Representative (AIR).

    Is the Bureau of Indian Standards (BIS) license mandatory to import products to India?

    Generally, the certification scheme of the Bureau of Indian Standards (BIS) is voluntary in nature.  However, some products (notified by the Government of India under Quality Control Orders)can be imported to India provided they have an Indian Standard (IS) mark logo and a valid license from the Bureau of Indian Standards (BIS).