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    2020-Checklist Requirements CPR

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    Cha Gabriel
    The document is a checklist of 14 requirements that must be submitted for a Certificate of Product Registration of Medical Devices in the Philippines. It outlines documentation needed such as an application form, licenses, certificates, product specifications, labeling materials, stability studies, and samples. Requirements include valid licenses and certificates from the manufacturer's country and third-party facilities. Electronic copies of documents arranged by the checklist are required to be submitted in PDF format along with a hard copy of the payment receipt.

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    2020-Checklist Requirements CPR

    Uploaded by

    Cha Gabriel
    105 views1 page
    The document is a checklist of 14 requirements that must be submitted for a Certificate of Product Registration of Medical Devices in the Philippines. It outlines documentation needed such as an application form, licenses, certificates, product specifications, labeling materials, stability studies, and samples. Requirements include valid licenses and certificates from the manufacturer's country and third-party facilities. Electronic copies of documents arranged by the checklist are required to be submitted in PDF format along with a hard copy of the payment receipt.

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    The document is a checklist of 14 requirements that must be submitted for a Certificate of Product Registration of Medical Devices in the Philippines. It outlines documentation needed such as an application form, licenses, certificates, product specifications, labeling materials, stability studies, and samples. Requirements include valid licenses and certificates from the manufacturer's country and third-party facilities. Electronic copies of documents arranged by the checklist are required to be submitted in PDF format along with a hard copy of the payment receipt.

    Copyright:

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

    2020-Checklist Requirements CPR

    Uploaded by

    Cha Gabriel
    The document is a checklist of 14 requirements that must be submitted for a Certificate of Product Registration of Medical Devices in the Philippines. It outlines documentation needed such as an application form, licenses, certificates, product specifications, labeling materials, stability studies, and samples. Requirements include valid licenses and certificates from the manufacturer's country and third-party facilities. Electronic copies of documents arranged by the checklist are required to be submitted in PDF format along with a hard copy of the payment receipt.

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    © All Rights Reserved
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    Download as pdf or txt
    of 1

    QWP-CDRRHR/LRD-02 Annex 02

    Rev. No. 06 Date Effective: 10 February 2020

    CHECKLIST OF REQUIREMENTS FOR CERTIFICATE OF PRODUCT


    REGISTRATION OF MEDICAL DEVICES

    1. Table of Contents (with page number)


    2. Notarized Application Form from Distributor (Importer/ Exporter/ Wholesaler)/ Local
    Manufacturer/Trader
    3. Valid License to Operate (LTO) of Distributor (Importer/ Exporter/ Wholesaler)/ Local
    Manufacturer/Trader
    4. Valid 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. Valid 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. Valid 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 with control
    measures, if applicable
    11. Stability study of the product duly signed by the person who conducted the studies to justify claimed
    expiration date. For accelerated study, submit computation to justify the storage condition used. 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 photo of the actual commercial product sample
    without its packaging
    14. Evidence of registration fee/payment (charge slip/official receipt)

     Submit an electronic/scanned copy (in PDF searchable format of at least 150 dpi)
     The soft copy should be arranged according to the checklist of requirements. The file name should consist
    of the name of the requirement. The electronic copy should be contained either in one single continuous
    file per requirement or single continuous file for all requirements.
     Bring hard copy of the assessment slip

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