Citizen Charter – Center for Device Regulation, Radiation Health, and Research (CDRRHR)

RADIATION REGULATION DIVISION APPLICATIONS 

LICENSING AND REGISTRATION DIVISION APPLICATIONS 

Online Application of Radiation Facilities

1. Issuance of User’s Account
2. Issuance of Certificate of Safety Evaluation (CSE)
3. License to Operate (LTO) of X-Ray Facilities
   • LTO Documentary Requirements
     • 3.A Medical X-Ray Facility
       • 3.A.1 General Radiography / Fluoroscopy and Interventional
       • 3.A.2 Computed Tomography / Mammography
     • 3.B Non-Medical X-Ray Facilities
       • 3.B.1 Anti-Crime (Utilizing LINAC)
       • 3.B.2 Education, Training and Research
       • 3.B.3 Industrial (Open-Type Industrial Radiography, Non – Destructive Testing and Applications Utilizing LINAC And Computed Tomography)
       • 3.B.4 Dental (Panoramic/Cephalometric and CBCT)
       • 3.B.5 Veterinary 

4.  Certificate of Facility Registration (CFR) of X-Ray Facilities

   • Certificate of Facility Registration Documentary Requirements
     • 4.A Medical X-Ray Facility (Bone Densitometry)
     • 4.B Non-Medical X-Ray Facility
       • 4.B.1 Anti-Crime (Security and Baggage Inspection System)
       • 4.B.2 Industrial (Closed-Type Industrial Radiography)
       • 4.B.3 Dental (Periapical)
5. Major and Minor Variation of License to Operate (LTO)/Certificate of Facility Registration (CFR)
   • Steps for Initial Application for a LTO and Major Variation
   • Steps for Renewal Application of LTO, Initial/Renewal Application of CFR
   • Steps for Minor Variation of LTO & CFR

Certificate of Product Registration/Notification

1. Initial Application for Certificate of Medical Device Notification (CMDN)
2. Application for Certificate of Medical Device Listing (CMDL)
3. Initial Application for Certificate of Medical Device Registration (CMDR) for Class B
4. Abridged Approval for Initial Application for Certificate of Medical Device Registration (CMDR) For Class B
5. Initial Application for Certificate of Medical Device Registration (CMDR) for Class C And D
6. Abridged Approval for Initial Application for Certificate of Medical Device Registration (CMDR) For Class C And D
7. Renewal Application of Medical Devices for All Classifications (CMDN for Class A and CMDR for Class B, C, & D)
8. Turned Initial Application for Certificate of Medical Device Registration (CMDR) for Class B
9. Turned Initial Application for Certificate of Medical Device Registration (CMDR) for Class C & D
10. Application for Certificate of Free Sales (CFS)
11. Application for Compassionate Permit
12. Initial Application for Certificate of Product Registration (CPR) for In-Vitro Diagnostic Devices/Reagents (IVD)
13. Renewal Application for Certificate of Product Registration (CPR) for In-Vitro Diagnostic Devices/Reagents (IVD)
14. Turned Initial Application for Certificate of Product Registration for In-Vitro Diagnostic Devices/Reagents (IVD)
15. Initial Application for Sales Promo Permit
16. Amendment Application for Sales Promo Permit
17. Initial Registration of Equipment/Devices Used to Treat Sharps, Pathological and Infectious Wastes
18. Renewal Registration of Equipment/Devices Used to Treat Sharps, Pathological and Infectious Wastes
19. Turned Initial Registration of Equipment/Devices Used to Treat Sharps, Pathological and Infectious Wastes (for CPR’s that are expired beyond 120 days/4 months and above)
20. Initial Registration of Water Purification Devices/System
21. Renewal Registration of Water Purification Devices/System
22. Turned Initial Registration of Water Purification Services/System
23. Application for Variation of Certificate of Product Registration (CPR) for Certificate of Product Registration (CPR) of In-Vitro Diagnostic Devices/Reagents and Certificate of Medical Device Registration (CMDR) of Medical Devices
24. Compliance for CMDR and IVDR Initial Applications
25. Re-application for CMDR and IVDR Initial Applications
26. Compliance for Renewal of Medical Devices and In-Vitro Diagnostic Devices/Reagents (IVD) for All Classifications
27. Re-application for Renewal of Medical Devices and IVD for all Classifications
28. Compliance for Variation Applications

Manual Application of Radiation Facilities

1. Issuance of Certificate of Compliance (COC)
   • Certificate of Compliance Documentary Requirements
     • 1.1 Medical X-Ray Facility
     • 1.2 Dental X-Ray Facility
2. Issuance of Certificate of Registration (COR) for Magnetic Resonance Imaging
   • Certificate of Registration (COR) Documentary Requirements
3. Issuance of LTO for Therapeutic X-Ray Facility (Utilizing LINAC)
4. Amendment of COC, LTO and COR Documentary Requirements
   • Steps – Initial Application for the Issuance of COC
   • Steps – Renewal/Amendment Application for COC and Initial/Renewal/Amendment Application for COR
5. Pre-Operational Permit (POP) for Therapeutic X-Ray Facilities
6. Clearance for Customs Release