Question & AnswerQ&A (FDA CIRCULAR NO. 2017-013)
The primary purpose is to streamline the process of issuance of a Clearance for Customs Release (CFCR) for radiation devices to ensure control, identification, distribution, and traceability of these devices entering the Philippines.
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA) is empowered to regulate the import and export of radiation devices.
A CFCR is a document issued by the CDRRHR that allows and informs the Bureau of Customs to release regulated imported radiation devices.
All ionizing and non-ionizing radiation devices used for medical and non-medical applications listed in the Circular require a CFCR before being released by the Bureau of Customs.
No. Non-emitting radiation devices are not required to secure a CFCR from the CDRRHR.
Requirements include: Number of units, intended use, importer/supplier details, owner/facility address, notarized letter for buyer submission, Certificate of Product Registration or equivalent safety certificate, brochure/literature, importer's permit, and proforma invoice.
Yes. A notarized letter guaranteeing submission of the CPR within 60 days from receipt of the written request may be submitted in lieu of the CPR.
The CFCR application shall be processed within three (3) working days after payment has been made.
The fee is Three Hundred Pesos (₱300.00) per device payable to the Food and Drug Administration.
Only device accessories intended as replacements of radiation-emitting parts such as RF coils, ultrasound probes, and X-ray tubes require CFCR, but accessories like cassettes, printers, and software do not.
The legal basis includes Presidential Decree No. 480 as amended by PD No. 1372, and Republic Act No. 9711, the Food and Drug Administration Act of 2009.
The invalidity or unconstitutionality of any section does not affect the remaining provisions, which remain valid and enforceable.
It repeals and replaces Bureau Order No. 020 s. 2007 which revoked BO No. 032 s. 2006 and set guidelines on issuance of clearances for radiation devices.
Yes, it applies to all radiation devices used for both medical and non-medical applications entering the Philippines.
A Certificate of Product Registration is required prior to BOC release for these devices, with a Certificate of Exemption required for exempted products.