G/TBT/N/PHL/329  
16 April 2024  
(24-3184)  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 SAMUEL A. ZACATE  
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 shal l 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@fda.gov.ph  ; bps.smd@dti.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):  OPTICAL, 
PHOTOGRAPHIC, CINEMATOGRAPHIC, MEASURING, CHECKING, PRECISION, MEDICAL 
OR SURGICAL INSTRUMENTS AND APPARATUS; PARTS AND ACCESSORIES THEREOF (HS 
code(s): 90)  
5. Title, number of pages and language(s) of the  notified document:  Extension of the 
Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the 
List of Registrable Medical Devices Based on FDA Circular No. 2020 -001-A entitled 
"Amendment to Annex A of FDA Circular No. 2020 -001 re: Initial Implementation of 
Administrative Order No. 2018 -0002 "Guidelines Governing the Issuance of an 
Authorization for a Medical Device based on the ASEAN Harmonized Technical 
Requirements""; (3 page(s), in English)  
6. Description of content:  This Circular aims to provide guidelines on the extension of the 
regulatory flexibility for Class B, C and D medical devices that are not included in the list 
of registrable medical devices based on FC No. 2020 -001-A. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/PHL/329  
 
- 2 - 
 
  8. Relevant documents:   
• 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 (FC) No. 2020 -001-A entitled "Amendment to Annex A of FDA 
Circular No. 2020 -001 re: Initial Implementation of Administrative Order No. 
2018-0002 "Guidelines Governing the Issuance of an Authorization fo r a Medical 
Device based on the ASEAN Harmonized Technical Requirements""  
• FC No. 2021 -002 entitled ""Full Implementation of Administrative Order No. 
2018-0002 entitled "Guidelines Governing the Issuance of an Authorization for a 
Medical Device based on the  ASEAN Harmonized Technical Requirements""  
• Amendments of FC No. 2021 -002 (FC No. 2021 -002 A / B / C)  
9. Proposed date of adoption:  Refer to V. Guidelines  
Proposed date of entry into force:  This Circular shall take effect fifteen (15) days after 
its publication in the Official Gazette or in any newspaper of general circulation and upon 
filing with the University of the Philippines Law Center Office of the National Administrative 
Register.  
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  
Makati City  
Philippines  
1200 
Tel: (632) 751 4700; (632) 7913128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/wp -content/uploads/2024/03/FDA -Circular -No.2024 -003.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_02636_00_e.pdf