Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products

New Amendment Brings Clarity to the Importing Process

On June 3, 2022, the Philippines’ FDA issued Circular No.2017-013-A to amend Circular No. 2017-013 and provide additional guidance for importing radiation products into the Philippines. The amendment is titled FDA Circular No. 2017-013-A: “Guidelines On The Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR)” and updates the guidance to align FDA Circular 2017-013 with DOH AO 2018-0002 and to help clarify the Clearance for Customs Release (CFCR) requirements for the industry and at the Bureau of Customs (BOC).

The new requirements will be implemented next April with a traditional CFCR and License to Operate (LTO) being honored for Bureau of Customs (BOC) release until March 31, 2023. Starting April 1, 2023, all Class B, C, and D medical radiation devices will need to have a Certificate of Medical Device Registration (CMDR) or Certificate of Medical Device Notification (CMDN). For CMDNs/CMDRs still under review when the new requirements go into effect, the proof of CMDN application, along with the CFCR and LTO will need to be presented at customs to be permitted entry.

Clearance for Customs Release (CFCR) Form

The Clearance for Customs Release (CFCR) form is required for the importation of radiation emitting products into the Philippines. Both medical devices and non-medical device radiation emitting products require a CFCR. The CFCRs are issued by the CDRRHR in about 3 days and applicants will need to submit the number of units, intended use, supplier and importer information, etc. Radiation emitting products require proof of safety as part of the CFCR application. Products will either need to show approval from the FDA in the form of a CPR/CMDN/CMDR or proof that the product is allowed to be sold in the country of origin. More detailed CFCR guidance can be found in Circular No. 2017-013.

Radation Medical Devices That Need a CFCR for Importation

Per FDA Circular No.2017-013-A:, the following radiation products are required to provide a CMDR or CMDN when filing import entries with the BOC:

1. Conventional X-ray Machines
2. Dental Panoramic X-ray Machines
3. Laser Pointers (Laser for Medical, Ophthalmological, & Dental Purposes)
4. Medical Computed Tomography (CT) X-ray machines
5. Electron Microscopes
6. Computed Tomography (CT) Dental X-ray Machines
7. Dental Conventional X-ray Machines
8. Dental Panoramic X-ray Machines
9. Digital Radiography X-ray Machines
10. UV/Laser Devices (for Dermatology or Cosmetic Purposes)
11. Linear Accelerators
12. Mammography X-ray Machines
13. Medical Computed Tomography (CT X-ray Machine)
14. Mobile X-ray Machines
15. Portable X-ray Machines
16. Tomotherapy Machines
17. Transportable X-ray Machines
18. Magnetic Resonance Imaging (MRI)
19. Ultrasound Machines
20. Bone Densitometers
21. Interventional X-ray Machines
    1. Positron Emission Tomography machines
    2. Single photon emission computed tomography (SPECT) machines
    3. Stereotactic Radiosurgery Machines
    4. Gamma Camera

Accessories and software intended to be used in combination with a medical radiation device “to enable the latter to be used for its intended purpose” and as required by Section VI.1 of DOH AO No. 2018-0002, are required to have a Certificate of Medical Device Notification (CMDN) or CMDR prior to its release. Other radiation devices not list above will also require a CMDR or CMDN depending on its classification.

Exceptions: At this time, replacement components such as RF coils, x-ray tubes, etc. and other medical device spare parts to not require a CMDN or CMDR but will still need a CFCR.

Devices for Research, Clinical Studies, and Donation Only

Medical radiation devices and accessories intended strictly for research, clinical studies, clinical investigations, exhibits, private use of health institutions, sample product for analysis/testing with ongoing application, or donated brand new medical devices will need to apply for, and obtain, a Certificate of Medical Device Listing (CMDL).

Medical devices and accessories of donated through the Bureau of International Health Cooperation (BIHC), as defined by DOH AO No. 2020-0001 or the “Guidelines in the Importation, Facilitation, and Management of Foreign Donations involving Health and health-Related Products,” will need to request an FDA clearance for foreign donations.