G/TBT/N/PHL/252  
7 May 2021  
(21-3909) 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:   
FOOD AND DRUG ADMINISTRATION PHILIPPINES  
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 di fferent from above:   
Engr. Maria Cecilia C. Matienzo  
Director IV  
Center for Device Regulation, Radiation Health and Research (CDRRHR)  
Civic Drive Filinvest Corporate City  
Alabang, Muntinlupa City  
Tel. no: +632 8 857 -1900 
mccmatienzo@fda.gov.ph ; cdrrhr@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):  Medical 
devices  
5. Title, number of pages and languag e(s) of the notified document:  FDA Circular 
No. 2021 -001 Hierarchy of Product Standards for Medical Devices to be Complied with for 
Notification/Registration Purposes (2 page(s), in English)  
6. Description of content:  This Administrative Order was formula ted to guide the local 
manufacturer, importer and/or distributor of medical devices regarding the product 
standards to conform prior to notification/registration with the Philippines' Food and Drug 
Administration as part of the implementation of Administra tive Order No. 2018 -0002: 
Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the 
ASEAN Harmonized Technical Requirements.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/PHL/252  
 
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  8. Relevant documents:   
• Republic Act No. 9711 or Food and Drug Administration Act of 2009  
• Implementing Rules and Regulation of Republic Act No. 9711  
• Administrative Order No. 2018 -002: Guidelines Governing the Issuance of an 
Authorization for a Medical Device based on the ASEAN Harmonized Technical 
Requirements  
• FDA Circular No. 2021 -001: Initial Implementation of Administrative Order 
No. 2018-0002 "Guidelines Governing the Issuance of an Authorization for a 
Medical Device Base d on the ASEAN Harmonized Technical Requirements"  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  Not applicable  
11. Texts available from:  National enquiry point [ ] 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  
Makat i City, Philippines 1200  
(632) 7751 4700; (632) 7751 4706  
Email: bps@dti.gov.ph   
http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/wp -content/uploads/2021/01/FDA -Circular -No.2021 -001.pdf