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    Application Form For Medical Device Registration: To The Director General

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    Marley M. Sabado
    1. The document is an application form for medical device registration submitted by Phil.Pak Pharma Inc. to the Food and Drug Administration of the Philippines. 2. The application is for initial registration of a Class B medical device and provides details of the device, applicant company, and certifications required for registration. 3. The applicant certifies that all information provided is true and correct, and that they will comply with requirements regarding manufacturing, adverse events, recalls, and any future changes requiring notification or approval.

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    Application Form For Medical Device Registration: To The Director General

    Uploaded by

    Marley M. Sabado
    111 views2 pages
    1. The document is an application form for medical device registration submitted by Phil.Pak Pharma Inc. to the Food and Drug Administration of the Philippines. 2. The application is for initial registration of a Class B medical device and provides details of the device, applicant company, and certifications required for registration. 3. The applicant certifies that all information provided is true and correct, and that they will comply with requirements regarding manufacturing, adverse events, recalls, and any future changes requiring notification or approval.

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    1. The document is an application form for medical device registration submitted by Phil.Pak Pharma Inc. to the Food and Drug Administration of the Philippines. 2. The application is for initial registration of a Class B medical device and provides details of the device, applicant company, and certifications required for registration. 3. The applicant certifies that all information provided is true and correct, and that they will comply with requirements regarding manufacturing, adverse events, recalls, and any future changes requiring notification or approval.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    111 views2 pages

    Application Form For Medical Device Registration: To The Director General

    Uploaded by

    Marley M. Sabado
    1. The document is an application form for medical device registration submitted by Phil.Pak Pharma Inc. to the Food and Drug Administration of the Philippines. 2. The application is for initial registration of a Class B medical device and provides details of the device, applicant company, and certifications required for registration. 3. The applicant certifies that all information provided is true and correct, and that they will comply with requirements regarding manufacturing, adverse events, recalls, and any future changes requiring notification or approval.

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    QWP-CDRRHR/LRD-14 Annex 04

    Rev. No.00 Date Effective: 13 March 2020

    APPLICATION FORM FOR MEDICAL DEVICE REGISTRATION

    TO THE DIRECTOR GENERAL


    Food and Drug Administration
    Department of Health

    ATTN: The Director


    Center for Device Regulation, Radiation Health, and Research

    Sir/Madam:

    In accordance with R.A. 9711 and other related issuance/s, we wish to apply for the (×) initial ( ) renewal
    registration of our product.

    APPLICATION FOR MEDICAL DEVICE REGISTRATION

    Device Name:

    Device Proprietary/Brand Name:

    Model/Reference Number/Property Code/Item Code:

    Classification:

    × Class B Class C Class D

    Intended Use of Device:

    Applicant’s Company Name: Phil.Pak Pharma Inc.

    Address: 247 Hana Bldg. El Grande Ave. BF Homes, BF International, Las Pinas, Metro Manila

    LTO No. 3000003642411 Validity: 11 February 2023

    Tel No. 8252 6515/ 09752634909 Fax. No. E-mail address: regulatory@philpakpharma.com

    Company Owner/General Manager: Mohamad A. Elbeitam

    Regulatory Officer: Vincent Benedict E. Sabado, RPh.

    Legal Manufacturer(Product Owner):


    Address:

    Manufacturing site:

    We hereby certify that the foregoing information and all other data submitted in connection with this application are
    true and correct. We understand that the failure to report all required information or submission of false or
    misleading information is an offense punishable by law. We certify that we have examined the following statements
    and we attest to their accuracy:
    QWP-CDRRHR/LRD-14 Annex 04
    Rev. No.00 Date Effective: 13 March 2020

    1. The Current Good Manufacturing Practice/ Quality Management System (ISO) is applied in full in
    the manufacture of this product.
    2. The manufacturing procedure is exactly as specified in the submitted manufacturing process.
    3. The finished product is tested and certified to be fully compliant with the specifications in the
    accompanying documentation.
    4. The person releasing the product for sale is an authorized and/or qualified person.
    5. The procedures for control of the finished product have been validated.
    6. The applicant has a standard operating procedure for handling any adverse event related to the use of
    the device.
    7. The applicant has a standard operating procedure for handling product recalls.
    8. All the documentation referred to in this application is available for review during comprehensive
    inspection of the establishment.
    9. We shall change the brand name so submitted should the proper authority decide with finality that
    we have no right to appropriate and utilize the said brand name; and
    10. We shall acknowledge and agree to indemnify and/or hold FDA free and harmless against any and
    all third party claims arising from the acceptance of such brand name of the product for registration
    with FDA.
    11. The product covered by this declaration will not undergo any change in the ownership, registrant’s
    address/location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing
    process (if applicable), labeling or commercial presentation, and packaging of the product covered
    by this certificate of notification without prior approval of this office.
    12. We acknowledge and agree that in the event that there is an unauthorized change in the ownership,
    its address/location, manufacturer, ingredients, formulation, size, reference number, use,
    manufacturing process (if applicable), labeling or commercial presentation, and packaging of the
    product:
    i. The CDRRHR may automatically suspend the LTO and/or CMDR of the product
    i. We will voluntarily recall the product from the market; and
    ii. We will indemnify and/or hold CDRRHR free and harmless against any and all third
    party claims and/or actions pertaining to the above unauthorized change(s).

    Regulatory Officer: Owner/General Manager:

    Vincent Benedict E. Sabado, RPh. Mohamad A. Elbeitam


    SIGNATURE OVER PRINTED NAME SIGNATURE OVER PRINTED NAME
    Government issued ID Number: Government issued ID Number:
    PRC/0078738 DRIVER’S LICENSE/ N04-89-123645
    Date Issued: 03/21/2018 Date Issued: 10/08/2018
    Place of Issuance: Metro Manila Place of Issuance: Metro Manila

    SUBSCRIBED AND SWORN before me this __________ day of _____________________ affiant exhibiting to
    me his/her government issued ID Number indicated above.

    NOTARY PUBLIC

    Doc. No. ________


    Page No. ________
    Book No. ________
    Series of ________

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