G/TBT/N/PHL/279  
26 January 2022  
(22-0606) 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:   
DR. OSCAR G. GUTIERREZ, JR., MPA  
OIC-Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
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:   
MARIA CECILIA C. MATIENZO  
Director IV  
Center for Device Regulation Radiation Health and Research (CDRRHR)  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: mccmatienzo@fda.gov.ph ; cdrrhr -prsdd@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 Medical Devices; In vitro diagnostic test systems (ICS 11.100.10)  
5. Title, number of pages a nd language(s) of the notified document:  Draft 
Administrative Order entitled "Rules and Regulations Governing the Issuance of an 
Authorization for an In -Vitro Diagnostic Medical Device (IVD) (25 page(s), in English)  
6. Description of content:  This Adminis trative Order aims to specify the rules, guidelines, 
procedures and requirements of the FDA -CDRRHR relative to the issuance of an 
authorization for IVD.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of hu man health or safety; Other  
8. Relevant documents:   
Republic Act No. 9711 and its Implementing Rules and Regulations  
ASEAN Medical Device Directive (AMDD)  G/TBT/N/PHL/279  
 
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  9. Proposed date of adoption:  This Administrative Order shall take effect fifteen (15) days 
following its publication in one (1) newspaper of general circulation or upon filing of the 
same to the Office of the National Administrative Register, University of the Philippines  
Proposed date of entry into force:  This Administrative Order shall take effect fifteen 
(15) days following its publication in one (1) newspaper of general circulation or upon 
filing of the same to the Office of the National Administrative Register, University of the 
Philippines  
10. Final date for comments:  7 February 202 2 
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
MR. NEIL P. CATAJAY  
Director  
Bureau of Philippine Standards  
Department of Trade and Industry  
3F Trade and Industry Building  
361 Sen. Gil Puyat Avenue  
Makati City, Philippines 1200  
(632) 7751 4700; (632) 7751 4706  
Email: bps@dti.gov.ph  
http://www.bps.dti.gov.p h 
https://www.fda.gov.ph/draft -for-comments -rules-and-regulations -governing -the-
issuan ce-of-an-authorization -for-an-in-vitro-diagnostic -medical -device -ivd/ 
https://members.wto.org/crnattachments/2022/TBT/PHL/22_0871_00_e.pdf