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Application Form Initial CPR

FDA medical device registration application form for initial registration of medical device/ in vitro diagnostic device

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: QWP-CDRRHR/LRD-02 Annex 04
Rev. No. 05 Date Effective: 18 October 2017

APPLICATION FORM FOR THE INITIAL REGISTRATION OF
MEDICAL DEVICE/IN VITRO DIAGNOSTIC DEVICE
ENGR. BAYANI C. SAN JUAN, MSc, MNSA, CESE
Director IV
Center for Device Regulation, Radiation Health, and Research
Food and Drugs Administration
Department of Health

ATTENTION:

Licensing and Registration Division

Sir/Madam:
In Accordance with R.A. 9711 and other related issuances, we wish to apply for the initial registration of our
product.
Name of Medical Devices
Brand Name (if any)
Size/Product Code/Reference Number

Primary Packaging (Market or
Commercial Presentation)

Enclosed are the documents stated in the Checklist of Requirements for Registration and representative samples of
our product.
We categorically declare that all data and information submitted in connection with this application as well as other
submission in the future are true and correct and reflect the total information available. We certify that we have
examined the following statements and we attest to their accuracy:
1. The Current Good Manufacturing Practice Guidelines for Medical Device is applied in full in the
manufacture of this product.
2. The formulation per dosage form is in agreement with the master formula and with the batch
manufacturing record forms (if applicable).
3. The manufacturing procedure is exactly as specified in the master formula and batch manufacturing
records.
4. Product covered by this declaration will not undergo any change in the formulation, size, reference
number, use, manufacturer, manufacturing process, labeling or commercial presentation without prior
approval of this office.
5. Each batch of the finished product is tested and certified to be fully compliant with the specifications
in the accompanying documentation.
6. The person releasing the product for sale is an authorized and/or qualified person.
7. The procedures for control of the finished product have been validated.
8. The market authorization holder has a standard operating procedure for handling any adverse event
related to the use of the device.
9. The market authorization holder has a standard operating procedure for handling batch recalls.
10. All the documentation referred to in this application is available for review during a GMP inspection.

QWP-CDRRHR/LRD-02 Annex 04
Rev. No. 05 Date Effective: 18 October 2017

11. We shall change the brand name so submitted should the proper authority decides with finality that
we have no right to appropriate and utilize said brand name; and
12. We shall acknowledge and agree to indemnify and/or hold BFAD free and harmless against any and
all third party claims arising from the acceptance of such brand name of the product for registration
with BFAD.
For and in behalf of ______________________________________________________________ (Name of
Company):
QUALIFIED PERSON
Signature
Name (print or type)
Position (print or type)
Date

_________________________
_________________________
_________________________
_________________________

OWNER / GENERAL MANAGER
Signature
_________________________
Name (print or type)
_________________________
Position (print or type)
_________________________
Date
_________________________

ACKNOWLEDGMENT
SUBSCRIBED AND SWORN TO BEFORE ME this _______________ at _____________________
personally appeared the following:
Name

Residence
Certificate/Government
Issued ID

Date Issued

Place Issued

1.
2.
Known to me and to me know to be the same persons who execute the foregoing instrument and they acknowledged
to me that the same is their free and voluntary act and deed.
WITNESS MAY HAND AND SEAL on the date and place first above written.
Doc. No.
Page No.
Book No.
Series of

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