G/TBT/N/PHL/258  
23 July 2021  
(21-5790) 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  
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  
Food and Drug Administration  
Department of Health  
Email: mccmatienzo@fda.gov.ph ; cdrrhr -prsd@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 
equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft FDA 
Circular No: ____ List of Class A Medical Devices (33 page(s) , in English)  
6. Description of content:  This issuance aims to guide the manufacturers, importers, 
distributors and all other concerned stakeholders regarding the list of medical devices 
classified as Class A and to help the industry to determine the appr opriate authorization 
specifically Certificate of Medical Device Notification (CMDN) to apply for their medical 
device products that fall under Class A classification.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  G/TBT/N/PHL/258  
 
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  8. Relevant documents:   
• DOH Administrative Order (AO) 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. 2020 -001-A Initial Implementation of Administrative Order No. 
2018-002 -  Guidelines Governing the Issuance of an Authorization for a Medical 
Device based on the ASEAN Harmonized Techni cal Requirements  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) days following 
its publication in a newspaper of general circulation and upon filing three (3) certified 
copies to the University of the Philippines Law Center.  
Proposed date of entry into force:  This Circular shall take effect fifteen (15) days 
following its publication in a newspaper of general circulation and upon filing three (3) 
certified copies to the University of the Philippines Law Center.  
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:   
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) 751 4700; (632) 7913128  
bps@dti.gov.ph  
http://www.bps.dti.gov.ph  
Head of Organization  
https://www.fda.gov.ph/draft -for-comments -of-list-of-class-a-medical -devices/  
https://members.wto.org/crnattachments/2021/TBT/PHL/21_4820_00_e.pdf