Import License

Import License

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    ‘Importer’ means any natural or legal person established within the Indian territory that places a device from a third country in the Indian Market. The Indian medical device sector does not manufacture sufficient quantity of device as per the market demand. India mainly depends on importing medical devices to suffice with the healthcare demands.

    The Government of India has ensured that the medical device sector gets considered as significant as other sectors and has recently developed medical device rules, commonly known as Indian Medical Device Rules, 2017. This requires an authorised agent, who can apply for the grant of import license to the Central Licensing Authority (CLA)

    Import License

    Indian Authorised Agent

    An authorised agent is a person, firm or organization located in India appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India. The authorised agent will act as a liaison between CDSCO and the overseas manufacturer.

    Responsibilities of Authorised Agent:

    • Import of Medical Devices in India

    An authorised agent possessing a licence to manufacture for sale or distribution under Indian Medical Device Rules 2017, shall make an application for grant of import licence for medical device to the CDSCO through the online portal.

    • Recall of Medical Device

    Authorised agent, considers or has reasons to believe that a medical device, which has been imported, sold or distributed, is likely to pose risk to the health of a user or patient during its use and therefore may be unsafe, authorised agent shall immediately initiate procedures to withdraw the medical device in question from the market and patients, indicating reasons for its withdrawal and inform the competent authority the details thereof.

    Authorised agent shall immediately inform the competent authority and cooperate with them, if there are reasons to believe that a medical device which has been placed in the market, may be unsafe for the patients.

    Required Documentation

    1. Plant Master File:

    A Plant Master File shall be prepared as per the requirements of Part III, Appendix I. The plant master file contains information on production and/or control of device manufacturing carried out at the premises.

    2. Device Master File:

    A Device Master File shall be prepared as per the requirements of Part III, Appendix I. The Device Master File shall be prepared for each device or device category and includes the following:

    • Device description,
    • Design and Manufacturing Process,
    • Design verification & validation reports,
    • Essential Principles checklist,
    • Risk analysis report,
    • Clinical evaluation,
    • Biocompatibility reports,
    • Stability data,
    • Sterilization validation reports and
    • PMS data

    MD- Forms

    • Form MD-14: Application for issue of import license to import medical device
    • Form MD-15: License to Import Medical Device

    The license granted under form MD-15 shall remain valid until it is cancelled or suspended by the licensing authority. The authorized agent is responsible for depositing the license renewal fees and maintain its validity.

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