Import License and ETA Approval from WPC in India


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    CliniExperts provides 360 degrees regulatory support for obtaining WPC approval for the domestic and international markets. Foreign manufacturers and importers who want to import medical devices containing wireless technology can approach the expert professionals at CliniExperts.

    Import License and ETA Approval from WPC– Overview


    The purpose of this service is to assist in the WPC certification process. The WPC certificate is required by manufacturers and the importers of medical devices that contain wireless technology such as cellular, RFID, Wi-Fi, or Bluetooth. In addition, the De-license frequency band products need ETA approval and a separate importer license based on the ETA grant letter.

    The regulatory bodies involved in the process are the Wireless Planning and Co-ordination Wing (WPC) and the Ministry of Communications.

    The following procedure needs to be followed to avail the WPC certificate:

    • Reviewing of the Frequency range in RF (Radio Frequency Exposure) Test Report
    • Preparation of complete document set
    • Online payment of the Government Fee
    • Filing of the application form in the prescribed format to the respective RLOs at Delhi/ Mumbai/ Chennai/ Kolkata/ Guwahati
    • Attaching the required list of documents with the application
    • Submission of the application along with the fee to the WPC department

    The entire application procedure takes around 30-40 working days.

    Who Can Apply?


    Any importer and manufacturer of Bluetooth and Wi-Fi who wants to sell their medical devices in the Indian market can apply for the WPC certificate and ETA approval. If the applicant is a foreign company, an authorised agent can assist them in the WPC approval process. The authorised agent will be an Indian representative for the foreign company, assisting in WPS approval in India.


    How To Apply?

    The following steps need to be followed for the application process:
    Step 1: An online application and the hard copy of the application must be submitted to the WPC department office.
    Step 2: Equipment working in a license-free frequency band must undergo an online procedure. Otherwise, a routine process can be followed concerning regional RLO involving an application for certification (WPC/ DPL/NDPL/ WPC Import License etc.).
    Step 3: The WPC department issues WPC certificates after the verification of the documents, in the form of Equipment type approval (ETA), Dealer Possession License (DPL), Non-Dealer Possession License (NDPL) and Import License for radio gadgets.

    Fee Involved

    The Government charges specific fees for the WPC certification process; the application fee is INR 10000 for the ETA Approval.

    Validity

    The WPS certificate has lifelong validity. No period restriction for ETA and renewal is applicable.

    Important Documents

    The following documents are required for ETA approval. Business owner photo id proof of owner Business owner address proof Proof of possession of premises Company documents such as company incorporation documents or partnership deed Radio Frequency Exposure Report (RF Report) · Product technical guide or user manual
    The major documents for Import License (IL) approval:
    ETA CertificateProforma InvoicePurchase Order

    Timeline to get Form from Central Drugs Standard Control Organisation

    The Government timeline to obtain ETA approval is 30-40 working days.

    Essential Tips

    The following tips will be beneficial during the application process:

    It is a requirement to evaluate the product frequency bandwidth.


    A complete copy of an accredited test laboratory's Radio Test report (RF test report) is essential while applying.


    Test reports must include details such as resolution bandwidth, video bandwidth, Frequency span, sweep, etc.

     

    Some problems are commonly faced if the following aspects are not followed during the application procedure. By keeping these in mind, unnecessary delay in approvals can be avoided:

     

    An applicant must obtain the RF Test report from an ISO 17025 accredited foreign or NABL accredited Indian lab.


    The ETA approval shall be granted only to an Indian agency and not to any foreign manufacturer. Hence, the manufacturer must authorise an Indian agent to act on their behalf in case of the import of wireless medical devices.


    There should be no discrepancy in the product name, model number and frequency range in the submitted documents compared to the RF Test report.

    Expert Advise

    As experts in the field of regulatory approvals, we advice that:

    A foreign manufacturer must appoint an authorised agent in India in case of the import of wireless devices and obtain the requisite license from WPC.

    Any wireless system that functions in a de-licensed frequency band and requires to be imported in India that does not need a WPC license must obtain an ETA approval.

    These products include Bluetooth systems, cell phones, Wi-Fi technology, RFID and others.

    Frequently Asked Questions

    Who can be the applicant?

    The WPC certificate is granted only to the Indian agencies. Any foreign manufacturer that requires the approval must appoint an Indian authorised agent for the same and submit the authorisation letter stating the same with Authority.

    What are the applicable conditions for the ETA Self declaration application?

    ETA through self-declaration applies to the products that meet two conditions:

    • Exempted from import licensing requirements as per the Export and Import (EXIM) Policy of DGFT
    • Operation in the de-licensed frequency band(s) as per applicable Gazette Notifications Therefore, these products may be imported by submitting a self-declaration to Customs as per ETA approval.

    Is the import of wireless modules (not finished product) allowed under self-declaration?

    Yes. The import of wireless modules is allowed under self-declaration if a wireless module is exempted from licensing requirements in the Export and Import (EXIM) Policy of DGFT.

    What RF test Report is required for obtaining ETA?

    The Accredited Laboratory issues the RF test report for the product that requires the issuance of ETA. If the imported product has multiple RF modules, then all RF modules test report(s) must be uploaded without any alteration.

    Can ETA be utilised by persons other than the applicant for import without fees?

    Yes. Once ETA is issued for a product through Self-Declaration or RLO, other than the applicant, anyone can utilise it for import without any additional payment.

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