G/TBT/N/PHL/186  
 
18 August 2014  
(14-4761)  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: Center for Device Regulation, Radiation Health, and Research Food 
and Drug Administration, Department of Health 
Name and address (including telephon e 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 :  
Center for Device Regulation, Radiation Health, and Research 
Food and Drug Administration, Department of Health Bldg. 24, San Lorenzo Compound, Rizal Ave., Sta. Cruz, 1003 Manila, Philippines  Fax: (632) 711-6016, (632) 711-6824   
Emails: apperalta@fda.gov.ph ; apperalta@co.doh.gov.ph ; mccmatienzo@yahoo.com  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): This Administrative 
Order applies to all medical devices to be sold, imported, exported, manufactured, and used 
in the Philippines, except in-vitro diagnostic and refurbished medical devices, for both of which separate Administrative Orders shall be issued. 
5. Title, number of pages and language(s) of the notified document: Administrative 
Order - The New Documentary Requirements for the Registration of Medical Device Products (19 pages, in English)     
6. Description of content: This Administrative Order is formulated to govern the new 
documentary requirements for the registration of medical device products.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
The new documentary requirements are hereby promulgated to align the Philippine 
medical device regulatory requirements to the common submission dossier template as 
agreed upon by the ten (10) member countries under the ASEAN, as part of the ASEAN Medical Device Directive. 
8. Relevant documents:   
 Republic Act No. 9711 or Food and Drug Administration Act of 2009 
 Implementing Rules and Regulation of Republic Act No. 9711 
 FDA Memorandum Circular No. 2013-001: Guidelines on the Submission of LTO 
and CPR Application with Electronic Copy (E-Copy) 
 FDA Memorandum Circular No. 2014-005: Updated List of Medical Devices 
Required to be Registered Prior to Sale, Distribution and Use  G/TBT/N/PHL/186 
 
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  9. Proposed date of adoption: This order shall take effect immediately after publication in a 
newspaper of general circulation. The implementation of the registration of medical devices following the new set of regulatory requirements shall be one (1) year upon the effectivity of 
this Administrative Order.  
Proposed date of entry into force: This order shall take effect immediately after 
publication in a newspaper of general circulation. The implementation of the registration of 
medical devices following the new set of regulatory requirements shall be one (1) year upon 
the effectivity of this Administrative Order.   
10. Final date for comments: 13 September 2014 
11. Texts available from: National enquiry point [ X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Standards Mainstreaming Division 
Bureau of Philippine Standards Department of Tr ade and Industry 
361 Sen. Gil J. Puyat Avenue 
Makati City, Metro Manila, Philippines E-mail: bps@dti.gov.ph  
Tel.: (632) 751-3130 
Fax: (632) 751-4706