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Endorsement Of Predicate In-vitro Diagnostics In Import License in India - MD-14 & MD-15


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    Fast track your medical device imports with our MD-15 endorsed Predicate In Vitro Diagnostic service. Simplify compliance and expedite approval processes effortlessly.

    Endorsement Of Predicate In-vitro Diagnostics In Import License – Overview

    As per the Medical Devices Rules, 2017, an import license in form MD-15 is required for the import of in-vitro diagnostic devices (notified) in India. CDSCO must be notified of the manufacturing facility and products for import of IVDs (notified). Authorized agent with manufacturing or wholesale license for sale/distribution, shall apply online. To obtain an import license in form MD 15, the agent shall use form MD 14 for medical device import approval in India. The whole process of obtaining the license normally takes 6-9 months after submission of the application.
    import-license-for-medical-devices-cdsco-form-md-14-15

    Who Can Apply?

    Indian importers or authorized persons who wish to import in vitro diagnostic medical devices are eligible to apply.

    Endorsementof Predicate In Vitro Diagnostics in Loan License in India- MD 7Endorsement Of Predicate In-vitro Diagnostics In Import License in India - MD-14 & MD-15

    How To Apply?

    The Applicant must follow the following process:

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      To obtain the license, the applicant has to submit a endorsement application for import of IVDs via Form MD 14.
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    Validity

    Unless suspended or revoked by the CLA, the import license in Form MD 15 remains valid indefinitely. However, the license retention fee must be paid before the end of the five years from the date of issue, as stipulated in the second schedule.

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    Fee Involved

    The government charges for the application process of import license for class A & B IVDs for endorsed applications is:
    • One site: Nil
    • Each distinct medical device: 10 USD
    Import license for Class C & D IVDs for endorsed application is:
    • One site: Nil
    • Each distinct medical device: 500 USD

    Important Documents

    Important Documents

    The documents mentioned below should be present during the documentation process:

    • Device Master File
    • Site Master File
    • Wholesale License
    • Power of Attorney
    • Free Sale Certificate from GHTF

    Timeline to get MD-15 from Central Drugs Standard Control Organisation

    4-5

    Months

    Essential Tips

    The primary considerations that need to be made while preparing and submitting this application are:

    • It is mandatory to appoint an authorized agent, who holds manufacturing or wholesale license for sale or distribution.
    • Find out if the countries of the GHTF offer free sale certificates.
    • You should check the number of manufacturing sites involved in the application.
    • The obstacles or issues that are most likely to arise when applying and that can be easily avoided by ensuring all documentation is in place:
    • Following the MDR, 2017, the Power of Attorney must follow the same format.
    • As per MDR 2017, Device Master Files and Site Master Files must comply with the prescribed format.
    • As per MDR 2017, Device Master Files and Site Master Files must comply with the prescribed format.
    • It is must to follow the MDR's 2017 requirements for apostillation and notarization of a particular document.
    Expert Advise

    According to our experts, the importers should look out for the following during the application procedure:

    Power of Attorney must be prepared precisely since it constitutes the basis for the entire application for an IVD import license.

    It is important to align the product name and model number with the POA, FSC, Label IFU, and other technical documents.

    The grouping guidelines on IVDs issued by the government should be followed for the grouping of products. If you fail to comply with the government's request, you may be subject to additional fees.

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    Frequently Asked Questions

    Is it possible that the same product has more than one importer?

    Yes, it is possible. In that case, through a designated online portal of the Ministry of Health and Family Welfare in the Central Government, an authorized agent holding a license to manufacture for sale or distribution, or a wholesale license for sale or distribution under these rules, shall apply for grant of import license for In vitro diagnostics medical devices to the Central Licensing Authority using the Form MD 14 for obtaining a license.

    What paperwork is needed if there are several importers?

    Legal paperwork such as the MD 14, the updated Power of Attorney, government fees, manufacturing or wholesale licenses, labels, IFUs, and a copy of the import license that was granted previously must all be submitted by the new agent. Along with their name, address, and import license number for registration, the manufacturer must also provide an undertaking certifying that there have been no changes made to the device master file, plant master file, or other regulatory documentation given to CDSCO by the prior agent. When in doubt, seek advice from a specialist to ensure that all your documentation is in order.

    If importers want to register devices from more than one class—A, B, C, or D—what charge would the manufacturing site have to pay?

    As per the Second Schedule, the manufacturer needs to submit the fees for different classes of the products (In vitro diagnostics medical devices). If the organization is manufacturing all classes of the product, then the fees pertaining to the higher class need to be paid.

    Will a new license be needed if the authorized Agent changes?

    Yes, a new license will be needed if an Indian-authorized agent changes.

    Would there be a site fee if an application for an endorsement were made?

    If the application is endorsed, the authorized individual just needs to pay the Device fee according to the class they are in.