Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

A LICENSE TO OPERATE (LTO) A MEDICAL X-RAY FACILITY

1. Duly accomplished medical x-ray license application form (2 copies).
License application fee (refer to the schedule of fees below). Either a photocopy of the machine validated
Land Bank of the Philippines (LBP) OnColl Payment Slip or Manager’s Check or Cashier’s Check payable to
2. FOOD AND DRUG ADMINISTRATION. For LBP payment, you may visit FDA website through this link
for the guidelines for payment portal: https://ww2.fda.gov.ph/index.php/issuances-2/cdrrhr-laws-and-regulations-
pertaining-to-all-regulated-medical-devices/cdrrhr-fda-circular/508371-fda-circular-no-2018-004.
Photocopy of the Official Receipt or certificate of subscription of the personal dose monitor (TLD or OSL)
3. from the provider of personnel dose monitoring service.
Photocopy of the VALID Professional Regulation Commission (PRC) license of all the radiologist/s and
4. radiologic/x-ray technologist/s.
Photocopy of the certificate of all the radiologist/s for being a Fellow of the Philippine College of Radiology
5. (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/x-ray technologist/s.
6. (FOR RENEWAL APPLICATION WITH NO CHANGES ON CURRENT RADIOLOGIC/
X-RAY TECHNOLOGIST/S, THIS REQUIREMENT IS OPTIONAL)
For Radiologic/X-ray Technologist who will act as the radiation protection officer (RPO), photocopy of the
certificate of training as proof that he/she had completed the RPO training provided by the FDA/DOH
7. recognized training service provider.
(FOR RENEWAL APPLICATION WITH NO CHANGES ON CURRENT RADIATION PROTECTION
OFFICER, THIS REQUIREMENT IS OPTIONAL)
Certificate of training of the head of the facility in radiology if he is not a FPCR/DPBR for government
8. facilities and in areas with no FPCR/DPBR within 45 km vicinity radius.
Photocopy of valid notarized contract of employment of all the radiologist/s and radiologic/x-ray
9. technologist/s. The CDRRHR recommends that the contract be valid for at least one year.
Photocopy of performance test report from FDA – CSL/DTI – PAB accredited testing body.
10. (FOR INITIAL/VARIATION APPLICATION OF CT SCAN/MAMMOGRAPHY ONLY)
Duly filled-up and notarized affidavit of continuous compliance.
11. (FOR RENEWAL APPLICATION ONLY)
Photocopy of the business/mayor’s permit or SEC/DTI registration of the facility.
12. (FOR INITIAL/VARIATION APPLICATION ONLY)
13. Photocopy of the latest License to Operate. (FOR RENEWAL APPLICATION ONLY)
Photocopy of a valid vehicle LTO registration (OR/CR).
14. (FOR TRANSPORTABLE X-RAY FACILITIES ONLY)
Schedule of Fees (per x-ray machine)
RENEWAL Renewal of Expired LTO
mA RANGE INITIAL 1 st
Month 2 nd
Month 3rd Month 4th Month > 4 months
(ValidLTO)
100 and below 810.00 410.00 1,250.00 1,290.00 1,330.00 1,370.00 1,770.00
101 up to 300 1,111.00 560.00 1,715.00 1,770.00 1,825.00 1,880.00 2,431.00
301 up to 500 1,414.00 710.00 2,180.00 2,250.00 2,320.00 2,390.00 3,094.00
501 up to 700 1,717.00 860.00 2,645.00 2,730.00 2,815.00 2,900.00 3,757.00
greater than 700 2,020.00 1,010.00 3,110.00 3,210.00 3,310.00 3,410.00 4,420.00

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 asfollows:
“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.”
2. 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 becollected.
3. Incomplete requirements shall not beprocessed.
4. For initial/renewal application, fee paid shall be forfeited when the facility fails to comply with the licensing requirements within 15 days upon
proper notice from theCDRRHR.

Civic Drive, Filinvest City, Alabang, 1781Muntinlupa City

Trunk Line: (632) 857 1900, Fax No. (632) 807 0751
URL: http://www.fda.gov.ph; e-mail: [email protected]
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Document No: QWP-CDRRHR/RRD-01-Annex 1.1

Revision: 04

APPLICATION FORM FOR A LICENSE TO OPERATE A MEDICAL X-RAY 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 For CDRRHR use

X New application Renewal of LTO Amendment to existing LTO# DTN No:
Reason/s for amendment:
I General Information
Name of Facility: Thru mail
Facility Address: Walk-in

ContactNo./s : Fee Paid

PHP:
Name and Address of the Applicant, Legal Person, Company, Organization, etc. O.R #
Name: Position/Designation: DatePaid
Address:
ContactNo./s: Email Address: [email protected] Assessed by:

II Name and qualifications of the personnel working in the medical x-ray facility Date:
Head of the Facility (Radiologist) : Radiation Protection Officer Evaluated by:

Name: Name:
Date: _
Qualification: FPCR DPBR Qualification:
Others: SIGNATURE: Status of the Facility:
PRC ID#/ Validity:
SIGNATURE:
Chief Radiologic/X-ray Technologist : Medical/Health Physicist * Action taken :

Name: Name:
Qualification: RRT RXT Qualification:
PRC ID#/Validity: SIGNATURE:
SIGNATURE:
*if available
III Declaration of the veracity of information: To be signed by the legal person/owner
Checked by:
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. Date:

Printed by:
Printed Name and Signature
Position: Date:
Date: Recommending
Approval:

Date:

Encoded by:

Date:

Page 1 of 2

Civic Drive, Filinvest City, Alabang, 1781Muntinlupa City

Trunk Line: (632) 857 1900, Fax No. (632) 807 0751
URL: http://www.fda.gov.ph; e-mail: [email protected]
 IV Equipment Specifications (All x-ray equipment in diagnostic and/ or interventional radiologyfacility)

Manufacturer Maximum Maximum Serial No.

Control Console Tube Model Control Console Tube Application/Use Location
mA kVp
G.E. - Refurbished G.E. - Refurbished KH 17 300 562734 199418

* For Application/Use, indicate whether ** For Location, indicate location of x-ray machine such as :
- Radiography (Stationary/Mobile) - Lithotripsy - Radiology Department (Room Number)
- Radiography/Fluoroscopy (MobileC-Arm) - Mammography - Floor, Building
- BoneDensitometry - ComputedTomography
- Radiography/Fluoroscopy(Stationary) - TumorLocalization/Simulation

V Name and qualifications of other radiologists and radiologic/x-ray technologists working in thediagnostic
and/ or interventional radiologyfacility
PRC
Name Designation Qualification Validity Signature
License

Please use separate sheet if necessary

VI Name and qualifications of other medical practitioners (i.e. nurses, cardiologist, interventionalist,etc.)
working in the diagnostic and/or interventional radiologyfacility:
PRC
Name Designation Qualification Validity Signature
License

Please use separate sheet if necessary

VII X-ray Service Category: (Tick appropriate radiologyservices)

General Radiography
Level One x-ray facility which is capable of performing the following non-contrast radiographic examinations:
Chest for Heart and Lungs Vertebral Column Shoulder Girdle
Extremities Localization of Foreign Body Thoracic Cage
Skull Pelvis Abdomen
Level Two x-ray facility which is capable of performing examinations done in the primary category and the following non-contrast
and contrast radiographic examinations:
Upper G.I. series Esophagography[Ba. Swallow] Paranasal Sinuses
Small Intestinal Series Pelvimetry Scoliotic Series
Barium Enema Fetography Skeletal Survey
Hysterosalpingography Cardiac Studies with Barium Imperforated Anus
Oral Cholegraphy Myelography Intravenous Pyelography
Level Three x-ray facility which is capable of performing examinations done in the primary and secondary categories and the
following invasive procedures:
Sinugraphy Tomography All Non-Cardiac Percutaneous Procedures
Fistulography Pacemaker Implants Visceral & Peripheral Angiography
Sialography Retrograde Cystography Operative & Post-operative Cholangiography
Bronchography Cerebral Angiography Endoscopic Retro. Cholangio. Pancreatography
Retrograde Urography Lymphography/Lympangiography
Specialized Diagnostic and Interventional X-ray Services
Computed Tomography Mammography Digital Subtraction Angiography
Lithotripsy Bone Densitometry Percutaneous Transluminal Angioplasty
Cardiac Catheterization Tumour Localization and simulation

Application Form for a License to Operate a MedicalX-ray Facility Page 2 of2