G/TBT/N/PHL/203  
 
28 May 2018  
(18-3164) 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 – Center for Device Regulation, 
Radiation Health and Research  
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:   
Engr. Bayani C. San Juan, MSc, MNSA  
Center for Device Regulation, Radiation Health and Research  
Food and Drug Administration  
Civic Drive, Filinvest City, Alabang 1781  
Muntinlupa, Philipppines  
E-mail: info@fda.gov.ph , cdrrhr_prsdd@fda.gov.ph   
Telephone No.: (632) 749.9443/711.6842/857.1900 loc 8301  
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): 
ICS: 11.040.50 – Radiographic Equipment  
5. Title, number of pages and language(s) of the notified document: Food and Drug 
Administration Circular 2017 -013: Guidelines on the Issuance of Clearance for Customs 
Release of Radiation Devices  (6 page(s), in English)   
6. Description of content: The Center for Device Regulation, Radiation Health, and 
Research (CDRRHR) of the Food and Drug Administration (FDA) is empowered to regulate 
the import and export of radiation devices that can be ionizing such as x -ray devices and 
non-ionizing such as laser, ultrasou nd, scanners and infrared radiation devices and others.  
The above -mentioned devices shall not be allowed to enter the country unless a Clearance 
for Customs Release (CFCR) has been issued by CDRRHR. This is to ensure control on the 
said devices entering th e country, and that persons importing and receiving the said 
devices are identified.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: This circular is issued to streamline the process of issuance of a CFCR for 
radiatio n devices. This rationalization will guarantee the identification, distribution and 
inventory for traceability of all radiation devices to their importer establishments and their 
endusers in the country.  G/TBT/N/PHL/203  
 
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  8. Relevant documents:   
 Presidential Decree (PD) No. 480 – "Creating a Radiation Health Office in the 
Department of Health"  
 Republic Act No. 9711 – "The Food and Drug Administration of 2009"  
 Bureau Order (BO) No. 020 s. 2007 – "Revocation of BO no. 032 s. 2006 and 
Promulgating of Guidelines on Issuance o f Clearance for Release of Radiation 
Emitting Device by the Bureau of Customs"  
 Administrative Order No. 50 s. 2001  
 Customs Memorandum Order No. 9 -2015 
9. Proposed date of adoption: This Circular shall be made of record and shall take effect 
immediately  
Proposed date of entry into force: This Circular shall be made of record and shall take 
effect immediately  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Engr. Bayani C. San Juan, MSc, MNSA  
Center for Device Regulation, Radiation Health and Research  
Food and Drug Administration  
Civic Drive, Filinvest City, Alabang 1781  
Muntinlupa, Philipppines  
E-mail: info@fda.gov.ph , cdrrhr_prsdd@fda.gov.ph   
Telephone No.: (632) 749.9443/711.6842/857.1900 loc 8301  
Attached copy: FDA Circular No. 2017 -013: Guidelines on the Issuance of C learance for 
Customs Release of Radiation Devices  
https://members.wto.org/crnattachments/2018/TBT/PHL/18_2704_00_e.pdf