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Annex 2 Checklist of Requirements for Registration of Water Purification
FDA requirement checklist for registration of water purification devices system
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Revision No. 01 Date Effective: 01 January 2018
CHECKLIST OF REQUIREMENTS FOR REGISTRATION OF WATER
PURIFICATION DEVICES/SYSTEM
A. FOR INITIAL APPLICATION
1.
2.
3.
4.
5.
6.
7.
8.
Dully accomplished application form
Copy of DTI Certificate of Registration/SEC Articles of Incorporation
Copy of Mayor’s Permit
Copy of Operation Manual
Layout of devices
List of raw materials used as components of the water purification device/system
Label/labelling/product insert of manufacturer’s performance claim
For special claims, data from scientific research and laboratory analysis supporting and
proving the claims of the manufacturer of the product
9. Vicinity map of office
B. FOR RENEWAL APPLICATION
1.
2.
3.
4.
Duly accomplished application form
Affidavit of Continuous Compliance
Test reports from laboratories accredited by the DOH
Copy of old Certificate of Health Related Device Registration
NOTE:
• 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
