Radiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine FDA. The new procedure, announced through FDA Circular 2017-013 on November 16, 2017, with immediate effect, replaces a similar process overseen by the Bureau of Customs.
For each shipment, importers of radiation-emitting devices must obtain a Clearance for Customs Release (CFCR) certificate issued by the FDA’s Center for Device Regulation, Radiation Health, and Research (CDRRHR). Applications will be processed within 3 working days for a fee of US$6 (Philippine Peso 300) per device.
One of the required elements of the CFCR application is a certificate of product registration issued by the national authority in the country of origin. This document must be Authenticated by the Philippines embassy in the country of origin. Sufficient time should be allocated to fulfill this requirement.
A copy of FDA Circular 2017-013 is available at the bottom of the Philippines market page on Asia Actual’s website.