G/TBT/N/PHL/263  
27 August 2021  
(21-6465) 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 diffe rent from above:   
MARIA CECILIA C. MATIENZO  
Director IV  
Center for Device Regulation, Radiation Health, and Research  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Contact: (02) 8815 -9600  
Email: cdrrhr@fda. gov.ph ; cdrrhr.rrd@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  [X]:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Machines 
for the reception, conversion and transmission or regeneration of voice, images or other 
data, incl. switching and routing apparatus ( excl. telephone sets, telephones for cellular 
networks or for other wireless networks) (HS 851762); Transmission apparatus for radio -
broadcasting or television, whether or not incorporating reception apparatus or sound 
recording or reproducing apparatus; t elevision cameras, digital cameras and video 
camera recorders (HS 8525); Computer tomography apparatus (HS 902212); Apparatus 
based on the use of X -rays for dental uses (HS 902213); Apparatus based on the use of 
X-rays, for medical, surgical or veterinary uses (excl. for dental purposes and computer 
tomography apparatus) (HS 902214); Radiation protection (ICS 13.280)  
5. Title, number of pages and language(s) of the notified document:  Updated 
Guidelines for Payment of Applications with the Radiation Regulat ion Division of the 
Center for Device Regulation, Radiation Health, and Research (CDRRHR -RRD), repealing 
FDA Circular No. 2018 -004, (4 page(s), in English)  
6. Description of content:  The proposed issuance aims to outline, harmonize, and 
consolidate the up dated guidelines for payment of applications with the Radiation 
Regulation Division of the Center for Device Regulation, Radiation Health, and Research 
(CDRRHR -RRD), repealing FDA Circular No. 2018 -004. G/TBT/N/PHL/263  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Provide updated clarificatory guidelines for the payment of applications with 
the Radiation Regulation Division of the Center for Device Regulation, Radiation Health, 
and Research (CDRRHR -RRD).; Other  
8. Relevan t documents:   
• FDA Circular 2018 -004: "Guidelines for Payment of Applications with the 
Radiation Regulation Division of the Center for Device Regulation, Radiation 
Health, and Research (CDRRHR -RRD)"  
• DOH Administrative Order (AO) No. 2020 -0035: "Rules and R egulations on the 
Licensing and Registration of Radiation Facilities Involved in the Use of Radiation 
Devices and Issuance of Other related Authorizations"  
9. Proposed date of adoption:  4th quarter of 2021  
Proposed date of entry into force:  15 days after publication  
10. Final date for comments:  30 days from notification  
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  
(632) 7751 4700; (632) 7751 4706  
Email: bps@dti.gov.ph   
http://www.bps.dti.gov.ph