Clinics and other healthcare establishments should take it upon themselves to be responsible for the safety of their radiology equipment by acquiring the necessary licenses for their use.
To use a radiography equipment, your facility would need the Philippine Food and Drug Administration’s (FDA) license to operate (LTO) a medical x-ray facility. On top of that, you also need to monitor your equipment’s emitted radiation by subscribing to a personnel dose monitoring service like the OSL Dosimetry service offered by TÜV Rheinland.
So how to get an x-ray license and ensure the safety of your operators? Due to the pandemic, both the FDA and TÜV Rheinland have streamlined their processes so we can send applications online. Ahead, we detail all the requirements and steps in subscribing to an OSL Dosimetry service and in getting an LTO for your establishment.
TÜV Rheinland OSL Dosimetry Service
In our country, radiography facilities have to first subscribe to radiation monitoring services like TÜV Rheinland’s OSL Dosimetry service. Only after securing this would they be able to apply for the FDA Philippines’ license to operate a medical x-ray facility.
Authorized by FDA as a designated provider of radiation protection services, TÜV Rheinland provides dosimetry services using Optically Stimulated Luminescence or OSL technology to measure the radiation exposure of your workers.
How to Apply for TÜV Rheinland’s OSL Dosimetry Service
1. Accomplish the necessary forms
Download the TÜV Rheinland Philippines OSL application form. Enter the details about your facility and the radiation emitting equipment you want tested. When done, submit the accomplished form to oslservice@tuv.com.
2. Review the service quotation
Upon receipt, TÜV Rheinland will send a quote containing the complete breakdown of fees reflecting the number of dosimeter badges needed to measure the equipment.
3. Pay online
Settle the quoted OSL Dosimetry application through Banco De Oro (BDO). Once you submit a copy of your proof of payment, they’ll send your official receipt. Your badges will be delivered 15 working days after.
4. Process dose reports
When you subscribe to this OSL Dosimetry service, they will be offering InLight whole body dosimeters that respond to photon and beta radiations. After one to two months of use, OSL dosimeters are returned to their laboratories for proper measurement of radiation doses. They will then send you electronic copies of your radiation dose reports.
FDA Philippines License to Operate (LTO) a Medical X-ray Facility
Requirements for the application
FDA x-ray application form for medical facilities
X-ray equipment and facility self-assessment checklist
Relevant photos of your radiography equipment and facility. See the corresponding self-assessment checklist for details
Licensing application fee and a proof of payment copy
Copy of the Official Receipt or certificate of subscription to a personnel dose monitor service (TLD or OSL)
Copies of licenses of all radiologists and radiologic/x-ray technologists from the Professional Regulation Commission
Radiologists' certificate of fellowship from the Philippine College of Radiology (FPCR) or Diplomate Diplomate of the Philippine Board of Radiology (DPBR)
PRC board certificate of all the radiologic/x-ray technologist/s
A copy of the certificate of training given to the acting radiation protection officer (RPO) as proof of the completion of the RPO training provided by FDA or DOH
Certificate of training of the head of the facility in radiology if he is not a FPCR/DPBR for government facilities and in areas with no FPCR/DPBR within 45 km vicinity radius
Copy of notarized contract of employment of all the radiologists and technologists
Copy of the performance test report from FDA – CSL/DTI – PAB accredited testing body. (For initial/variation application of CT scan/mammography only)
Copy of business/mayor’s permit or SEC/DTI registration of the facility
Valid OR or CR of vehicle LTO registration (For transportable x-ray facilities only)
Steps to process your license to operate
1. Create an rrdPortal account.
In place of accepting walk-in transactions, the FDA has now developed an online rrdPortal to ensure safe authorization. Note that the FDA only grants access to either the owner or the authorized person of the facility. To create an account, fill out the corresponding details in their online sign up form and upload an accomplished Letter of Intent or Authorization Letter.
2. Process the licensing fees
Consult the schedule of fees above as listed on the application form for license to operate a medical x-ray facility. You can settle them through any branch of the Land Bank of the Philippines (LBP).
To limit your transactions online, applicants can also pay through the LANDBANK Link.BizPortal. This e-payments system can be accessed by LBP account holders, holders of ATM cards from other BancNet-member banks, international debit, credit, or prepaid card holders, and GCash users.
3. Submit all the requirements
Log in to your rrdPortal and follow the instructions for your LTO application. Compile the necessary documents as listed above and compile them in a labelled PDF file free of bugs and viruses.
4. Wait for assessment
Depending on the radiography machine and facility type you’re obtaining a license for, you can either simply submit a self-assessment or be subject to a virtual pre-licensing inspection. Check the FDA Circular No. 2020-045 on licensing inspections for more details.
Regardless of the application type, all is subject for post-licensing inspection after the quarantine measures have been lifted for verification. Once you gain the FDA Philippines’ license to operate a medical x-ray facility, your establishment must continuously comply with regulations and reassessments.
Ensure the safety of your x-ray facility
Want to take your mind off these applications and focus your efforts in improving the operations of your establishment? Secure your OSL Dosimetry service subscription and license to operate a medical x-ray facility efficiently with Care 4 Life.
To ensure the safety of your radiologists and technicians, our dedicated team can guide you as you comply with these x-ray safety guidelines. Make the processing of these licensing and monitoring requirements more convenient. Get started by sending us a message today.