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Annex 11 Justification and Promissory Letter

FDA letter of justification and promissory

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Revision No. 01 Date Effective: 01 January 2018

AFFIDAVIT OF CONTINUOUS COMPLIANCE
I, _________________________________ of legal age, single/married, and a resident of
________________________________________ after having been duly sworn to in accordance with law hereby
voluntarily depose and state:
1.

That I am the lawful registered owner of ____________________________________ with business
address at __________________________________________________.
2. That I am a holder of Certificate of Health Related Device Registration (CHRDR)
no.___________________
for
my
water
purification
device/system
___________________________________________________.
3. That I am applying for the renewal of the CHRDR specified in Item 2.
4. That since the issuance of the said CHRDR, I have faithfully subjected the product water from the said
water purification device/system to laboratory testing based on the frequency specified in the Philippine
National Standards for Drinking Water (PNSDW) to ensure compliance with the DOH Administrative
Order 2005-003 and other relevant and existing laws and regulations.
5. That I am attaching the test results conducted by a DOH accredited laboratory for bacteriological,
physical and chemical analysis on the said water purification device/system within the past six months
from the date of my CHRDR renewal application for evaluation by the technical staff of the DOH-Center
for Device Regulation, Radiation Health and Research (CDRRHR).
6. That if during the regular conduct of compliance monitoring, the CDRRHR staff found out that the water
purification device/system has noted deficiency/ies with the registration requirements, the CHRDR shall
be immediately suspended.
7. That if I failed to correct the noted deficiency/ies with 2 months after the conduct of monitoring, the
DOH shall revoke our CHRDR.
8. That by virtue of this sworn statement, I would like to manifest to the CDRRHR that our water
purification device/system is continuously complying with the registration requirements to ensure public
safety.
9. That this affidavit releases the CDRRHR of any legal liability in connection with the issuance of the said
CHRDR.
10. That I am executing this affidavit as a requirement for the renewal of registration of the said water
purification device/system for the year ______________.
IN TRUTH WHEREOF, I have hereunto signed my name below, this _____ day of ___________ 20___
at ___________________________.

___________________________
Affiant (Owner)
SUBSCRIBED AND SWORN to before me, this _____ day of 20____ by
_________________________ who exhibited to me his /her Community Tax Certificate No. ______ issued at
____________________ on _________.

____________________________
Notary Public

Doc. No. ________
Page No. ________
Book No. ________
Series of 20______
 
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