Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION Filinvest Corporate City Alabang, City of Muntinlupa CHECKLIST OF REQUIREMENTS FOR INITIAL ISSUANCE / RENEWAL OF A CERTIFICATE OF REGISTRATION (COR) OF A MAGNETIC RESONANCE IMAGING FACILITY 1. 2. Duly accomplished MRI registration 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 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-regulationspertaining-to-all-regulated-medical-devices/cdrrhr-fda-circular/508371-fda-circular-no-2018-004. 3. 4. 5. 6. 7. 8. 9. INITIAL 2,020.00 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 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) RENEWAL (Valid COR) 1,010.00 Schedule of Fees (per machine) Renewal of Expired COR 1st Month 2nd Month 3rd Month 4th Month 3,110.00 3,210.00 3,310.00 3,410.00 > 4 months 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 as follows: “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 be collected. 3. Incomplete requirements shall not be processed. 4. 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 Filinvest Corporate City Alabang, City of Muntinlupa 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 ACE MALOLOS DOCTORS, INC. Name of Facility :__________________________________________________________________ CAPITOL VIEW PARK SUBD., BULIHAN, MALOLOS CITY, BULACAN 3000 Facility Address :__________________________________________________________________ __________________________________________________________________ 09173043926 Contact No./s :__________________________________________________________________ Name and Address of the Applicant, Legal Person, Company, Organization, etc. FERDINAND MANUEL J. DACUMOS, MD PRESIDENT & CEO Name :_________________________________ Position/Designation :_____________________ Address : ________________________________________________________________________ CAPITOL VIEW PARK SUBD., BULIHAN, MALOLOS CITY, BULACAN 3000 acemdradiology@gmail.com Contact No./s:_____________________________ Email Address : ______________________ 09173043926 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 : JOHANNA L. DE VERA, MD Name : _________________________________ Qualification : FPCR DPBR Others: ________________ 0101276 / 08-03-2024 PRC ID#/ Validity :_______________________ RICHARD VINCENT R. LACORTE, RRT Name : ________________________________ 0011191 / 08-19-2025 PRC ID#/Validity : ______________________ SIGNATURE: Evaluated by: _____________ Date:_____________ 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: FERDINAND MANUEL J. DACUMOS, MD __________________________ Printed Name and Signature PRESIDENT & CEO Position:___________________ 02-21-2024 Date: _____________________ _____________ Date:____________ Printed by: _____________ Date:____________ Recommending Approval: _____________ Date:____________ Encoded by: _____________ Date:____________ Page 1 of 2 _______________________________________________________________________________________________ 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 Model Magnetic Field Strength (Tesla) System Serial No. Location MAGNETOM SEMPRA 1.5T 179961 MRI ROOM GROUND FLOOR Manufacturer SIEMENS V Name and qualifications of other radiologists and radiologic technologists working in the MRI facility Name Designation Qualification PRC License Validity JOHANNA L. DE VERA, MD RADIOLOGY HEAD OF RADIOLOGY 101276 8-3-2024 JAIME LUMIQUED, MD RADIOLOGY OIC HEAD RADIOLOGIST 106694 3-15-2024 RADIOLOGY CHIEF RADTECH 11191 8-19-2025 4-21-2026 RICHARD VINCENT R. LACORTE, RRT JACQUELINE B. SANTOS, RRT RADIOLOGY RADTECH 9549 JULIUS ELIEZER T. DOMINGONO, RRT RADIOLOGY RADTECH 9101 7-4-2024 ANDRÉ IAN DANIEL A. AQUINO, RRT RADIOLOGY RADTECH 16597 11-24-2023 Signature Please use separate sheet if necessary Application Form for a Certificate of Registration of a Magnetic Resonance Imaging Facility Page 2 of 2