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MRI Application Form

FDA checklist of requirements and form for magnetic resonance imaging facility

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Department of Health
Food and Drug Administration

CENTER FOR DEVICE REGULATION,
RADIATION HEALTH, AND RESEARCH
CHECKLIST OF REQUIREMENTS FOR INITIAL ISSUANCE / RENEWAL OF
A CERTIFICATE OF REGISTRATION (COR) OF A MAGNETIC RESONANCE IMAGING FACILITY

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Duly accomplished MRI registration form (2 copies).
Registration application fee (PHP 2000.00/machine for initial and PHP 1000.00/machine for
renewal). For mailed applications, Company’s Check or Manager’s Check shall be payable to the
FOOD AND DRUG ADMINISTRATION (PMO Address: Alabang, Muntinlupa City).
Photocopy of the VALID Professional Regulation Commission (PRC) license of all the radiologist/s
and radiologic technologist/s.
Photocopy of the certificate of all the radiologist/s for being a Fellow of the Philippine College of
Radiology (FPCR) or Diplomate of the Philippine Board of Radiology (DPBR).
(FOR RENEWAL APPLICATION WITH NO CHANGES ON CURRENT RADIOLOGIST/S,
THIS REQUIREMENT IS OPTIONAL)
Photocopy of the PRC board certificate of all the radiologic technologist/s.
(FOR RENEWAL APPLICATION WITH NO CHANGES ON CURRENT RADIOLOGIC/XRAY TECHNOLOGIST/S, THIS REQUIREMENT IS OPTIONAL)
Photocopy of valid notarized contract of employment of all the radiologist/s and radiologic
technologist/s. The CDRRHR recommends that the contract be valid for at least one year.
Photocopy of the business/mayor’s permit or SEC/DTI registration of the facility.
(FOR INITIAL/VARIATION APPLICATION ONLY)
Photocopy of the latest Certificate of Registration. (FOR RENEWAL APPLICATION ONLY)
Radiofrequency/Magnetic Field map. (FOR INITIAL APPLICATION ONLY)

Notes:
1. The surcharge/penalty for late filing of the renewal of LTO will be assessed pursuant to the Implementing Rules and Regulations
(Book II, Article I Section 3.A.2) of RA 9711 and to the FDA Circular No. 2011-004 as follows:

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3.
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“An application for renewal of an LTO received after its date of expiration shall be subject to a surcharge or penalty equivalent
to twice the renewal licensing fee and an additional 10% per month or a fraction thereof of continuing non-submission of such
application up to a maximum of one hundred twenty (120) days. Any application for renewal of license filed thereafter shall be
considered expired and the application shall be subject to a fee equivalent to the total surcharge or penalty plus the initial filing fee
and the application shall undergo the initial filing and evaluation procedure.”
Pursuant to FDA Circular No. 2011-003, a Legal Research Fee (LRF) amounting to “one percent (1%) of the filing fee imposed, but
in no case lower than ten pesos” shall be collected.
Incomplete requirements shall not be processed.
For initial/renewal application, fee paid shall be forfeited when the facility fails to comply with the licensing requirements within 60
days upon proper notice from the CDRRHR.

_______________________________________________________________________________________________
Civic Drive, Filinvest City, Alabang, 1781 Muntinlupa City
Trunk Line: (632) 857 1900, Fax No. (632) 807 0751
URL: http://www.fda.gov.ph; e-mail: cdrrhr_rrd@fda.gov.ph

Republic of the Philippines

Department of Health
Food and Drug Administration

CENTER FOR DEVICE REGULATION,
RADIATION HEALTH, AND RESEARCH
APPLICATION FORM FOR A CERTIFICATE OF REGISTRATION OF A
MAGNETIC RESONANCE IMAGING FACILITY
General Instructions: Write legibly and in BLOCK letters. Put an “x” mark on appropriate tick box. Completely fill-up
the required information and signatures. The CDRRHR will not receive and process unduly filled-up application forms.
For requirements, please refer to the attached checklist.
TYPE OF AUTHORIZATION
New application
Renewal of COR

Amendment to existing COR# _____________
Reason/s for amendment:__________________

I General Information
Name of Facility :__________________________________________________________________
Facility Address :__________________________________________________________________
__________________________________________________________________
Contact No./s
:__________________________________________________________________
Name and Address of the Applicant, Legal Person, Company, Organization, etc.
Name :_________________________________
Position/Designation :_____________________
Address : ________________________________________________________________________
Contact No./s:_____________________________
Email Address : ______________________

For CDRRHR use
DTN No:
__________________
Thru mail
Walk-in
Fee Paid
PHP:______________
O.R #_____________
Date Paid __________
Assessed by:

_____________
Date :_____________

II Name and qualifications of the personnel working in the MRI facility
Head of the Facility (Radiologist) :

Chief Radiologic Technologist :

Name : _________________________________
Qualification :
FPCR
DPBR
Others: ________________
PRC ID#/ Validity :_______________________

Name : ________________________________
PRC ID#/Validity : ______________________

Evaluated by:

_____________
Date:_____________

SIGNATURE:

Status of the Facility:

________________
________________
Action taken :

SIGNATURE:
III Declaration of the veracity of information: To be signed by the legal person/owner
I hereby declare that all the information provided on the form and in support of this application
is to the best of my knowledge complete and true in every particular.

________________
________________
________________
________________
________________
________________
Checked by:

__________________________
Printed Name and Signature
Position:___________________
Date: _____________________

_____________
Date:____________
Printed by:

_____________
Date:____________
Recommending
Approval:

_____________
Date:____________
Encoded by:

_____________
Date:____________

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_______________________________________________________________________________________________
Civic Drive, Filinvest City, Alabang, 1781 Muntinlupa City
Trunk Line: (632) 857 1900, Fax No. (632) 807 0751
URL: http://www.fda.gov.ph; e-mail: cdrrhr_rrd@fda.gov.ph

IV

Equipment Specifications
Manufacturer

V

Model

Magnetic Field Strength
(Tesla)

System Serial No.

Location

Name and qualifications of other radiologists and radiologic technologists working in the MRI facility
Name

Designation

Qualification

PRC
License

Validity

Signature

Please use separate sheet if necessary

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