G/TBT/N/PHL/212  
 
3 April 2019  
(19-2116) 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):  In vitro 
diagnostic test systems (ICS 11.100.10)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Administrative Ord er No. ___ : Rules and Regulations Governing the Issuance of an 
Authorization for an In -Vitro Diagnostic (IVD) Medical Device Based on the ASEAN 
Harmonized Technical Requirements (12 page(s), in English)  
6. Description of content:  Republic Act No. 9711, o therwise known as the "Food and Drug 
Administration Act of 2009", and its Implementing Rules and Regulations, declare that it 
is the policy of the state to insure the safety, efficacy and quality of IVD medical devices 
in the country so as to protect the h ealth of the Filipino people.  
The signing of the ASEAN Agreement on Medical Device Directive (AMDD) in 2014, 
mandated the Philippines to implement the following provisions to a) "require the person 
responsible for placing the IVD medical devices in that Me mber State or the authorized 
representative to register the IVD medical devices with the regulatory authority by of that 
Member State", b) "shall undertake all necessary measures to ensure that only IVD 
medical devices which conform to the AMDD may be plac ed on markets of that Member 
State" and c) "put in place an appropriate system for the registration of IVD medical 
devices with the Regulatory Authority of that Member State".  
The Department of Health through the Food and Drug Administration - Center for D evice 
Regulation, Radiation Health and Research (CDRRHR) hereby adopt, issues and 
implement the AMDD guidelines on the registration of IVD medical devices and to provide 
the regulatory requirement and registration process.  G/TBT/N/PHL/212  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Administrative Order aims to specify the rules, guidelines, procedures 
and requirements of the FDA -CDRRHR relative to the issuance of an authorizations for 
IVD medical devices adapting the prov isions of ASEAN AMDD.  
Protection of human health or safety  
8. Relevant documents:   
• Republic Act No. 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 [ ] 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_1876_00_e.pdf