G/TBT/N/PHL/283  
31 March 2022  
(22-2616) 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  
Officer -in-Charge 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  
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 [  ],3.2 [  ], 7.2 [  ], 
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 code(s): 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft FDA 
Circular entitled "Abridged Processing of Application for Registration/Notification of 
Medical Devices Approved by National Regulatory Authority of Any ASEAN Member 
Country"; (4 page(s), in English)  
6. Description of content:  The Circular aims to carry out good reliance practices in the 
regulatory processes of medical devices. Specifically, it intends to provide guidelines on 
the abridged processing of application for registration of medical devices  with product 
approval issued by the National Regulatory Authority of any ASEAN member country 
under the ASEAN Medical Device Directive - Common Submission Dossier Template 
requirements.  
7. Objective and rationale, including the nature of urgent problems w here 
applicable:  Protection of human health or safety  G/TBT/N/PHL/283  
 
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  8. Relevant documents:   
• Republic Act No. 9711 and its implementing rules and regulations  
• ASEAN Medical Device Directive (AMDD)  
• Administrative Order No. 2018 -0002 entitled "Guidelines Governing the Issuance 
of an Authorization for a Medical Device based on the ASEAN Harmonized 
Technical Requirements"  
• FDA Circular No. 2021 -002 entitled "Full Implementation of Administrative Order 
No. 2018 -0002 entitled "Guidelines Governing the Issuance of an Authoriz ation 
for a Medical Device based on the ASEAN Harmonized Technical Requirements"  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) days after its 
publication in an Official Gazette or in a newspaper of general circulation and fili ng three 
(3) certified true copies with the University of the Philippines Law Center - Office of the 
Administrative Register.  
Proposed date of entry into force:  This Circular shall take effect fifteen (15) days after 
its publication in an Official Gazette or in a newspaper of general circulation and filing 
three (3) certified true copies with the University of the Philippines Law Center - Office of 
the Administrative Register.  
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:   
Mr. Neil P. Catajay  
Director  
Bureau of Philippine Standards  
Department of Trade and Industry  
3F Trade and Indus try Building  
361 Sen. Gil Puyat Avenue  
Makati City  
Philippines  
(632) 751 4700; (632) 7913128  
bps@dti.gov.ph  
http://www.bps.dti.gov.ph  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_2453_00_e.pdf