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Retention of Import License in India in India - Form MD 14 & Form MD 15


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    Unlock growth and compliance with our Import License Retention Services for In Vitro Diagnostics (IVD). Ensure uninterrupted market access, stay compliant with changing regulations, and streamline your import licensing process. Trust us to safeguard your IVD business.

    Retention of Import License in India – Overview

    Retention of Import License service is required to retain the in-vitro diagnostic medical device import license granted in Form MD 15.

    An authorized agent who has the license to manufacture for sale or distribution/having a wholesale license/ having an MD 42 certificate for sale or distribution services shall make an application.

    The application must be made to the Central Licensing Authority through an online portal of the Ministry of Health and Family Welfare in the Central Government.

    Form MD 14 MD 15

    Who Can Apply?

    The authorized agent having the license to manufacture for sale or distribution/ wholesale license/ having an MD 42 certificate for sale or distribution services.

    How To Apply?

    The Applicant must follow the following process:

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      It has to be applied to the Central Licensing Authority through an online portal of the Ministry of Health and Family Welfare in the Central Government.
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    Validity

    The import license in Form MD 15 shall remain valid in perpetuity before completion of the period of 5 years, provided that the license retention fee has been paid as per the Second Schedule.

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    Fee Involved

    The fees required for Import license for Class A in-vitro diagnostic medical devices for:
    • One site - $1000
    • Each distinct in-vitro diagnostic medical device - $50
    The fees required for Import license for Class B in-vitro diagnostic medical devices for:
    • One site -$2000
    • Each distinct in-vitro diagnostic medical device - $1000
    The fees required for Import license for Class C or Class D in-vitro diagnostic medical devices for:
    • One site - $3000
    • Each distinct in-vitro diagnostic medical device - $1500

    Important Documents

    Important Documents

    The documents required are:

     
    • Valid Free Sale Certificate/Marketing Authorization of the product from the National Regulatory Authority of the following countries i.e., UK, EU, Canada, USA, Australia and Japan.
    • Valid Free Sale Certificate/Marketing Authorization of the product from the National Regulatory Authority of the country of origin (if any).
    • Each device’s recorded sales data in India during the last 5 years.
    • Valid copies of CE design certificate and Quality Certificate IS0 13485, if applicable.

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

    1 to 2

    MONTHS

    Essential Tips

    The documents required for the in-vitro diagnostic medical device import license application, preparation and submission are:

     
    • Valid Free Sale Certificate/Marketing Authorization of the product from the National Regulatory Authority of the following countries i.e., UK, EU, Canada, USA, Australia and Japan.
    • Valid Free Sale Certificate/Marketing Authorization of the product from the National Regulatory Authority of the country of origin (if any).
    • An undertaking that there is no change in Device Master File (DMF) and Plant Master File (PMF), duly signed and stamped by the manufacturer.
    • CAPA, duly signed and stamped by authorized agent or manufacturer.
    • Post marketing surveillance data (Vigilance reporting) during the last 5 years including details of complaints received.
    • Each device’s recorded sales data in India during the last 5 years.
    • Valid copies of CE design certificate and Quality Certificate IS0 13485, if applicable.
    Expert Advise

    The Central Licensing Authority can allow the license retention fee to be paid after the due date and before the expiry of 90 days.

    For this, a late fee will be calculated at the rate of 2% per license

    Furthermore, if the license retention fee is not deposited within the above stipulated period, the license will be cancelled.

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    Frequently Asked Questions

    Can the license holder submit the in-vitro diagnostic medical device import license fee after the due date?

    If the license holder pays the license fee after the due date and before the expiry of 90 days, then they will also have to pay a late fee which is calculated at the rate of 2% per mensem.

    Is post marketing surveillance data required for the retention of application?

    Yes, the post marketing surveillance data is required.