Question & AnswerQ&A (FDA CIRCULAR NO. 2018-004)
The main purpose of FDA Circular No. 2018-004 is to provide procedural guidelines for the payment of applications with the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health and Research (CDRRHR) assessed through the FDA Payment Portal.
The Circular covers payments for applications related to License to Operate (LTO), Certificate of Compliance (COC), Certificate of Registration (COR), Clearance for Customs Release (CFCR), and Radiofrequency Radiation (RFR) Safety Evaluation Report.
Payments for applications with the CDRRHR-RRD shall be assessed and made through the FDA Payment Portal accessible at http://rrdpayment.fda.gov.ph.
Applicants must provide the Application Type, Validity Date of existing/previous marketing authorization, the Facility/Establishment details such as name, complete address, contact details, and the details of the machine(s) including manufacturer, unit model, maximum mA, maximum kVp, console serial number, tube serial number, and application/use.
The applicant must print the system-generated Order of Payment, go to any LBP branch, present the printed Order of Payment, fill up the Oncoll Payment Slip with necessary account and reference numbers, present it to the teller, and secure the machine-validated Oncoll payment slip as proof of payment.
No. Payment of the fee does not guarantee that the application will be approved. The application will still be subject to evaluation by the FDA and compliance with relevant laws, rules, and regulations.
The applicant should submit a photocopy of the machine-validated Oncoll payment slip along with the application documentary requirements to any designated FDA or Department of Health receiving offices.
The Separability Clause ensures that if any section or provision is declared invalid, the validity of the remaining provisions shall not be affected or impaired.
Any previous orders, memorandums, issuances, rules, and regulations that are inconsistent with this Circular are modified or repealed accordingly as per the Repealing Clause.
The Circular took effect fifteen (15) days after its publication in the Official Gazette or in a newspaper of general circulation and upon filing with the UP Law Center, Office of the National Administrative Register.