G/TBT/N/PHL/213  
 
3 April 2019  
(19-2117) 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):  Medical 
equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Administrative Order No. ____ : Guid elines on the Conduct of Clinical Investigation of 
Medical Devices for Human Subjects in the Philippines (17 page(s), in English)  
6. Description of content:  The Philippines, as a signatory to the ASEAN Agreement on 
Medical Device Directive (AMDD), is mand ated to institutionalize an appropriate system 
for the conduct of clinical investigation of medical devices, taking into accout the Helsinki 
Declaration adopted by 18th World Medical Assembly in Helsinki, Finland, in 1964 and any 
subsequent amendments or r evisions to this Declaration by the World Medical Association.  
As the regulatory agency for medical devices in the Philippines and pursuant to the 
provisions of Republic Act 9711, otherwise known as the "Food and Drug Administration 
(FDA) Act of 2009", FDA  has been tasked to develop policies on the regulation of medical 
devices to ensure public health and safety from the use of these products. In addition, 
FDA is also given the power to conduct, supervise, monitor and audit research studies on 
health and sa fety issues of health products undertaken by entities duly approved by the 
FDA. 
To implement the mandate of FDA and to ensure that all measures relating to the 
protection of human subjects are carried out during the conduct of clinical investigation 
of med ical devices, this set of guidelines is hereby issued for strict compliance of all 
concerned.  G/TBT/N/PHL/213  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Order aims to establish guidelines on the conduct of clinical investigation 
of medical devices for human subjects in the Philippines. Specifically, it aims to ensure 
that the medical device is suitable for the population for which it is intended and to ensure 
the safety and well -being of subjects participating in the  clinical investigation.  
Protection of human health or safety  
8. Relevant documents:   
• 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 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, Al abang 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_1877_00_e.pdf