G/TBT/N/PHL/295  
11 November 2022  
(22-8447) 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 notific ation 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  
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 [  ], 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):  Radiation 
protection (ICS code(s): 13.280)  
5. Title, number of pages and language(s) of the notified document:  Guidelines on 
the Conduct of Regulatory Inspections for Radiation Facilities; (34 page(s), in English)  
6. Description of content:  FDA aims to operationalize and supplement the provisions of 
DOH AO No. No. 2020 -0035 providing for a rationalized process for t he conduct of 
regulatory inspections for radiation facilities. This FDA Circular is issued to revoke the FDA 
Circular No. 2020 -035 and provide uniform guidelines on the conduct of regulatory 
inspections for radiation facilities under the jurisdiction of th e FDA.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Circular aims to outline guidelines on the conduct of regulatory 
inspections for radiation facilities with alternative modes and approaches using digital 
means to the conduct of such in line with the graded approach established through DOH 
AO No. 2020 -0035.  G/TBT/N/PHL/295  
 
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  8. Relevant documents:   
• DOH Administrative Order No. 2020 -0035 or the Rules and Regulations on the 
Licensing and Registration of Radiation Facilities Involved in the Use of Radiation 
Devices and Issuance of Other Related Authorizations  
• FDA Circular No. 2020 -035 or "Interim Guidelines for the Conduct of Licensing 
Inspection for Radiation Facilities"  
9. Proposed date of adoption:  1st Quarter o f 2023  
Proposed date of entry into force:  15 days after publication  
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 Industry Building  
361 Sen. Gil Puyat Avenue  
Makati City  
Philippines  
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/uploa ds/2022/11/Draft -for-
Comments_CDRRHR_November -2022.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_7732_00_e.pdf