G/TBT/N/PHL/211  
 
3 April 2019  
(19-2115) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  PHILIPPINES   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Department of Health - Food and Drug Administration  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Engr. Bayani C. San Juan, Director IV  
Center for Device Regulation, Radiation Health, a nd Research (CDRRHR)  
Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines  
+632.857.1900 loc 8301  
info@fda.gov.ph  / eppayas@fda.gov.ph  
www.fda.gov.ph  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Water 
treatment devices/systems which product water is for drinking purposes; Water quality 
(ICS 13.060)  
5. Title, number of pages and langua ge(s) of the notified document:  Draft 
Administrative Order No. ___ : Policies and Guidelines on the Regulation of Water 
Treatment Devices/ Systems in the Philippines (14 page(s), in English)  
6. Description of content:  The proposed policy covers the manufa ctures, exporters, 
importers and distributors including establishments that assemble, repackage and re -
label water treatment systems or devices for the purpose of donation, promotion, giving 
free of charge, selling or commercial distribution in the Philipp ines. Furthermore, the 
guidelines also cover establishments that sell, install and/or provide repair and 
maintenance of water treatment system for local water district/water service provider, 
water refilling station, household, institution, food establishm ent, office and other 
commercial establishments.  
Water treatment systems used in the production of bottled water are not covered by these 
guidelines.  
The proposed policy is an amendment of the Department of Health Administrative Order 
2005- 0003 entitled " Guidelines on the Issuance of Certificate of Product Registration for 
Water Purification Equipment and Devices" and its subsequent amendments (AO 2005 -
0003-A, AO 2005 -0003-B, AO 2005 -0003-C). 
The regulatory agency that will implement the proposed policy is  the Department of 
Health – Food and Drug Administration.   G/TBT/N/PHL/211  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Administrative Order is promulgated to innovate and improve the 
regulation of water treatment devices/systems in the Philippines. Specifically, this AO 
aims to:  
1. Align and harmonize the regulation of water treatment devices/systems with the 
regulation of other health products under the jurisdiction of the FDA.  
2. Establish rules and regulations f or: 
a. licensing of establishments covered by this AO  
b. registration of water purification devices/systems  
c. packaging and labelling requirements for registered water treatment 
devices/systems  
d. donated water purification devices/systems;  
Consumer information, labelling; Prevention of deceptive practices and consumer 
protection; Protection of human health or safety  
8. Relevant documents:   
• PD 856 - Code on Sanitation of the Philippines  
• Administrative Order 2005 -0003 - Guidelines on the Issuance of Certificate of  
Product Registration for Water Purification Equipment and Devices  
• Administrative Order 2005 -0003-A 
• Administrative Order 2005 -0003-B 
• Administrative Order 2005 -0003-C 
• Republic Act 9711 - "Food and Drug Administration (FDA) Act of 2009"  
9. Proposed date of adoption:  This Order shall take effect 15 days after its publication in 
a national newspaper of general circulation.  
Proposed date of entry into force:  This Order shall take effect 15 days after its 
publication in a national newspaper of general circulatio n. 
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Center  for Device Regulation, Radiation Health, and Research (CDRRHR)  
Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines  
+632.857.1900 loc 8301  
info@fda.gov.ph  / eppayas@fda.gov.ph  
www.fda.gov.ph  
https://members.wto.org/crnattachments/2019/TBT/PHL/19_1875_00_e.pdf