Restructured Payment Collection for Applications with the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health and Research (CDRRHR)

2018-10-24T14:35:40+08:00 August 3rd, 2018|News & Events|
radiation regulation

The Philippines Food and Drug Administration (FDA) has launched a new policy and procedure, under FDA Circular No: 2018-004,  relating to the implementation of the FDA Payment Portal for applications made to the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health and Research (CDRRHR).

Background:
Pursuant to the issuance of Philippines FDA Circular No. 2017-010 dated 11 September 2017, the Food and Drug Administration (FDA) implemented a new policy and procedure on the collection of payments for applications with the agency, particularly applications made with the Radiation Regulation Division (RRD). The new policy and procedure, under the FDA Circular No: 2018-004, offers more payment option, thereby improving convenience and efficiency of transactions.


Consistent with the policy, the agency has developed a module on the FDA Payment Portal to cater for clients of the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health and Research (CDRRHR). The portal integrates previously manually-assessed orders of payment into a new collection system. In line with the implementation of the FDA Payment Portal for applications with the RRD, the following guidelines are hereby provided.

Scope:
The guidelines apply to all radiation facilities/establishments regulated by the FDA that aim to file the following applications: License to Operate (LTO), Certificate of Compliance (COC), Certificate of Registration (COR), Clearance for Customs Release (CFCR), and the Radiofrequency Radiation (RFR) Safety Evaluation Report.

Guidelines:
For applications made with the CDDRHR-RRD, the following guidelines apply:

1. All payments for applications (i.e. LTO, COC, COR, CFCR, RFR) filed with the CDRRHR-RRD will be assessed by the FDA Payment Portal at http://rrdpayment.fda.gov.ph

2. Applicants must provide all necessary information, as indicated in the online forms, to facilitate the processing of applications. These details include, but are not limited to the following:

LTO, COC, COR Applications
i. Application Type
ii. Validity Date of Existing/Previous Marketing Authorization
iii. Details of the Facility/Establishment

  • Name
  • Complete Address
  • Contact Details (e-mail, mobile, landline, fax)

iv. Details of the Machine/s

  • Manufacturer
  • Unit Model
  • Maximum mA
  • Maximum kVp
  • Console Serial No.
  • Tube Serial No.
  • Application/Use

CFCR Applications
i. Application Type
ii. Name of Importer
iii. Radiation Emitting Device to be Imported (maximum of 30 units per application)
iv. Details of the Facility/Establishment

  • Name
  • Complete Address
  • Contact Details (e-mail, mobile, landline, fax)

RFR Safety Evaluation Report Applications
i. Application Type
ii. RFR Facility Owner/Service Provider
iii. Contractor/Subcontractor Name
iv. RFR Transmitter Site
v. Details of the Facility/Establishment

  • Name
  • Complete Address
  • Contact Details (e-mail, mobile, landline, fax)

3. Payments shall be made in accordance with the existing collection policy (i.e. FDA Circular No. 2017-010), and through the authorized payment channel only

4. For Land Bank of the Philippines (LBP) Oncoll Payment Facility Transactions, the applicant facility shall follow these simple instructions.

  • Print the system generated Order of Payment after successfully completing the online assessment form
  • Proceed to any Land Bank of the Philippines (LBP) branch
  • Present the printed Order of Payment to the LBP and complete the Oncoll Payment Slip
  • Retain the machine validated LBP Oncoll Payment Slip as proof of payment

The payment fee is not a guarantee that the application will be approved. The processing of the application will still be subject to the evaluation of the concerned FD personnel and its compliance with the pertinent laws, rules, and regulations.

5. Once an application has been paid, the applicant facility shall submit a photocopy of the machine validated Oncoll payment slip together with the application requirements to any designated FDA or Department of Health (DOH) receiving offices.

Source:
FDA Circular No. 2018-004 (https://ww2.fda.gov.ph/attachments/article/508371/FDA%20CIRCULAR%202018-004.pdf)
FDA Philippines Website (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)