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  • Checklist of Requirements For The Renewal of License To Operate As Medical Device Importer/ Exporter/ Wholesaler/ Manufacturer/ Trader/ Re-Packer

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    Shamira Yessa Lazaro Espinosa
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    The document outlines the requirements for renewing a license to operate as a medical device importer, exporter, wholesaler, manufacturer, trader, or re-packer in the Philippines. It lists the standard requirements as the renewal form, original license to operate, and renewal fee. For manufacturers and re-packers, it additionally requires a financial statement. It provides notes for applications with 5 or more pages, requiring a notarized electronic copy of an affidavit and electronic/scanned copies of requirements on a DVD-R in a labeled white data folder.

    Original Description:

    fda

    Original Title

    01IRenewalLTOImpExpManuTradRepacker

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    The document outlines the requirements for renewing a license to operate as a medical device importer, exporter, wholesaler, manufacturer, trader, or re-packer in the Philippines. It lists the standard requirements as the renewal form, original license to operate, and renewal fee. For manufacturers and re-packers, it additionally requires a financial statement. It provides notes for applications with 5 or more pages, requiring a notarized electronic copy of an affidavit and electronic/scanned copies of requirements on a DVD-R in a labeled white data folder.

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    23 views1 page

    Checklist of Requirements For The Renewal of License To Operate As Medical Device Importer/ Exporter/ Wholesaler/ Manufacturer/ Trader/ Re-Packer

    Uploaded by

    Shamira Yessa Lazaro Espinosa
    The document outlines the requirements for renewing a license to operate as a medical device importer, exporter, wholesaler, manufacturer, trader, or re-packer in the Philippines. It lists the standard requirements as the renewal form, original license to operate, and renewal fee. For manufacturers and re-packers, it additionally requires a financial statement. It provides notes for applications with 5 or more pages, requiring a notarized electronic copy of an affidavit and electronic/scanned copies of requirements on a DVD-R in a labeled white data folder.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as doc, pdf, or txt
    of 1

    Republic of the Philippines

    Department of Health
    Food and Drug Administration
    CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH
    (former name : Bureau of Health Devices and Technology)
    LICENSING AND REGISTRATION DIVISION
    CDRRHR-2-L-01I
    Revision No. 2
    Date Effective: 15 April 2015

    CHECKLIST OF REQUIREMENTS FOR THE RENEWAL OF LICENSE TO


    OPERATE AS MEDICAL DEVICE IMPORTER/ EXPORTER/ WHOLESALER/
    MANUFACTURER/ TRADER/ RE-PACKER

    STANDARD REQUIREMENTS:

    1. Renewal Form
    2. Original LTO
    3. Renewal Fee

     Additional requirement for Manufacturer/Re-packer


    - Financial Statement

    Note:

     For applications/submissions with 5 pages and above

     Notarized Electronic Copy (E-copy) of Affidavit.

     In addition to the hard copy of the above mentioned standard requirements, the client shall
    also submit an electronic/scanned copy (in PDF Searchable Format at least 300dpi) on a
    DVD-R of the application.

     The above stated requirements shall be properly labeled with table of contents indicating the
    number of pages, divider with ear-tags and place in a White Data Folder.

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