   
  
G/TBT/N/PHL/214  
 
3 April 2019  
(19-2118) 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 addit ion, where applicable):  
Installations and equipment for waste disposal and treatment (ICS 13.030.40)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Administrative Order No. ___ : Guidelines on the Issuance of an Authorization fo r 
Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste 
(14 page(s), in English)  
6. Description of content:  The Department of Environment and Natural Resources (DENR) 
and the Department of Health (DOH) issued Joint DENR -DOH Admi nistrative Order No.  02 
series of 2005 to provide guidelines on the management of health care wastes relative to 
the Implementing Rules and Regulations (IRR) of Chapter XVIII - "Refuse Disposal" of 
the Code on Sanitation of the Philippines (P.D. 856).  
The Joint DENR -DOH Administrative Order mandated the DOH to require all health care 
waste treatment, storage, disposal (TSD) facility operators and health care waste 
generators with on -site waste treatment facilities to use DOH registered equipment or 
devices used for treatment of health care wastes.  
On 14 March 2007, Administrative Order No. 2007 -0014 was issued by the Secretary of 
Health through the Bureau of Health Devices and Technology (BHDT) to provide guidelines 
on the rules and regulations with resp ect to registration, monitoring and evaluation of 
devices and equipment used in the treatment of sharps, pathological and infectious 
wastes.  
Republic Act 9711, otherwise known as the "Food and Drug Administration (FDA) Act of 
2009" through its IRR enhance,  strengthen and rationalize the regulatory systems for 
establishment and products under its jurisdictions.  G/TBT/N/PHL/214  
 
- 2 - 
 
  To effectively implement the above provisions on the regulations of all devices and 
equipment used in the treatment of sharps, pathological and infectious wastes in the 
Philippines, the FDA -Center for Device Regulation, Radiation Health, and Research 
(CDRRHR) (formerly BHDT) hereby issues this Administrative Order.  
7. Objective and rationale, including the nature of urgent problems where 
applicab le: This Administrative Order aims to enhance and strengthen the existing rules 
and regulations of the FDA -CDRRHR relative to safety, efficacy and quality of equipment 
or devices used for treating sharps, pathological and infectious wastes.  
Protection of human health or safety  
8. Relevant documents:   
• P.D. 856 - Code on Sanitation of the Philippines  
• Administrative Order No. 2007 -0014 
• Republic Act 9711 - Food and Drug Administration 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 circulation.  
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_1878_00_e.pdf  
 