G/TBT/N/PHL/215  
 
3 April 2019  
(19-2120) 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):  Medical 
equipment (ICS 11.040), In vitro diagnostic test systems (ICS 11.100.10)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Administrative Order No. ___ _: Guidelines on the Labeling Requirements for M edical 
Devices in the Philippines (10 page(s), in English)  
6. Description of content:  The Food and Drug Administration (FDA) through the Center 
for Device Regulation, Radiation Health and Research (CDRRHR) is the primary agency 
authorized to enforce regul atory requirement on manufacture, importation, distribution, 
sale, and offering for sale of medical devices in accordance with the provisions of Republic 
Act 9711 also known as FDA Act of 2009, its Implementing Rules and Regulations (IRR). 
As stipulated in  the IRR, the CDRRHR is mandated to establish an effective regulatory 
system and mechanism to ensure the safety, quality and performance of medical devices 
in the Philippines.  
The Philippines as a signatory to the ASEAN Agreement on Medical Device Directive 
(AMDD), adheres to continuously harmonize the technical procedures and requirements 
to reduce diversity in the regulations of medical devices.  
The issuance of the guidelines on labeling requirements for medical devices, serves to 
communicate safe ty instructions related to information to users and/ or patients, as well 
as to standardize the required policy, and to assure the highest quality of medical devices 
used in the country.  G/TBT/N/PHL/215  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Administrative Order aims to provide guidelines on the labeling 
requirements for medical devices aligned with the provisions of the ASEAN Medical Device 
Directive.  
Consumer information, labelling; Protection of human health or safety ; Quality 
requirements  
8. Relevant documents:   
• 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_1879_00_e.pdf