January 15, 2018
On November 16th of 2017, Philippine Food and Drug Administration (FDA) announced that the importation and exportation of radiation devices that can be ionizing and non-ionizing shall not be allowed to enter the country unless a Clearance for Customs Release (CFCR) has been issued by the Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA). This is to ensure control on the said devices entering the country, and that persons importing and receiving the said devices are identified.
FDA Circular 2017-013 is issued to streamline the process of issuance of a CFCR for radiation devices. This guarantees traceability of identification, distribution and inventory of all radiation devices to their importer establishments and their end users in the Philippines.
This Circular shall apply to all importers of all radiation devices used for medical and non-medical applications that will be entering the country.
FDA Circular 2017-013 lists the radiation devices which requires CFCR. Guidelines for the issuance of CFCR are also outlined in Section V of the FDA Circular. An amount of PHP 300.00 per device shall be required prior to the processing of the application.
Foreign manufacturers, importers and authorized representatives should note that non-ionizing radiation devices are also covered by this circular.
FDA Circular 2017-013 was implemented last November 16, 2017 and can be found at this link.