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    Checklist - CPR Medical Device

    Uploaded by

    Kristelle Soriano
    The document outlines 14 requirements for obtaining a Certificate of Product Registration for medical devices in the Philippines, including: (1) a notarized application form from the distributor or manufacturer; (2) a notarized affidavit; (3) a valid license to operate; (4) registration approval from the country of origin authenticated by the Philippine consulate; and (5) documentation of the product's specifications, manufacturing process, labeling, and stability studies. Applicants must also submit electronic copies of documents on a DVD in PDF format.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd

    Checklist - CPR Medical Device

    Uploaded by

    Kristelle Soriano
    302 views1 page
    The document outlines 14 requirements for obtaining a Certificate of Product Registration for medical devices in the Philippines, including: (1) a notarized application form from the distributor or manufacturer; (2) a notarized affidavit; (3) a valid license to operate; (4) registration approval from the country of origin authenticated by the Philippine consulate; and (5) documentation of the product's specifications, manufacturing process, labeling, and stability studies. Applicants must also submit electronic copies of documents on a DVD in PDF format.

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    FDA-CDRRHR

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    The document outlines 14 requirements for obtaining a Certificate of Product Registration for medical devices in the Philippines, including: (1) a notarized application form from the distributor or manufacturer; (2) a notarized affidavit; (3) a valid license to operate; (4) registration approval from the country of origin authenticated by the Philippine consulate; and (5) documentation of the product's specifications, manufacturing process, labeling, and stability studies. Applicants must also submit electronic copies of documents on a DVD in PDF format.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    302 views1 page

    Checklist - CPR Medical Device

    Uploaded by

    Kristelle Soriano
    The document outlines 14 requirements for obtaining a Certificate of Product Registration for medical devices in the Philippines, including: (1) a notarized application form from the distributor or manufacturer; (2) a notarized affidavit; (3) a valid license to operate; (4) registration approval from the country of origin authenticated by the Philippine consulate; and (5) documentation of the product's specifications, manufacturing process, labeling, and stability studies. Applicants must also submit electronic copies of documents on a DVD in PDF format.

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    © All Rights Reserved
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    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-R-01A
    Revision No. 2
    Date Effective: 15 April 2015

    CHECKLIST OF REQUIREMENTS FOR CERTIFICATE OF PRODUCT


    REGISTRATION OF MEDICAL DEVICES
    REQUIREMENTS
    Notarized Application Form from Distributor (Importer/ Exporter/ Wholesaler)/
    Local Manufacturer/Trader
    2. Notarized Electronic Copy (e-copy) Affidavit
    3. Valid License to Operate (LTO) of Distributor (Importer/ Exporter/ Wholesaler)/
    Local Manufacturer/Trader
    4. Government Certificate of Clearance and Free Sale/Registration approval from
    the country of origin issued by the Health Authority and duly authenticated by the
    territorial Philippine Consulate for Imported Product
    5. Government Certificate attesting to the status of the manufacturer, competency
    and reliability of the personnel and facilities or valid ISO Certification for
    Imported Product. For imported products, certificate must be and duly
    authenticated by the territorial Philippine Consulate
    6. Certificate of Foreign Agency Agreement between the manufacturer and
    trader/distributor/importer regarding the product involved duly authenticated by
    the territorial Philippine Consulate
    7. Specific Use and Directions/Instruction for use
    8. List of all raw materials used as component of the product. Must include quantity
    and technical specifications or detailed information on physical and chemical
    properties of each component
    9. Brief description of the methods used, the facilities and control in the
    manufacture, processing, and packaging of the product. For sterile products,
    include sterilization standard parameters, sterilization procedures, validation
    protocol and results of latest sterilization revalidation with sterility tests. If the
    sterilization of the device is contracted out, submit copy of valid ISO Certificate
    of the contracted sterilizing company.
    10. Technical specifications and physical description of the Finished Product. Submit
    also the following: (a) Functionality/performance test data and results conducted
    on the finished product; (b) Test data and results of the Biocompatibility test of
    the device being registered; (c) Risk analysis and control of the device, if
    applicable
    11. Stability study of the product duly signed by the person who conducted the
    studies to justify claimed expiration date. If no expiration, submit justification
    from the manufacturer why the device has no expiration
    12. Labeling materials for all the sizes/reference codes to be used for the product:
    Immediate label, secondary packaging, box label and package insert/brochure,
    whichever is applicable
    13. Representative sample (as needed) and clear colored picture of the product.
    14. Evidence of registration fee/payment (charge slip/official receipt)
    1.

    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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