FDA Issues Amendment to FDA Circular No. 2017-013

The Philippine Food and Drug Administration (FDA) has issued FDA Circular No. 2017-013-A on June 30, 2022, which amends FDA Circular No. 2017-013, entitled "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)." This amendment applies to all imports of radiation devices used for medical and non-medical applications.

Key Revisions in FDA Circular No. 2017-013-A:

1. Section V.A.6:
   • Initial Version For radiation devices intended for medical use, a Certificate of Product Registration (CPR) or a similar document confirming the product's safety and authorization for sale in the country of origin is required. This document must be approved by the Philippine Consulate. If a CPR is not immediately available, a notarized letter guaranteeing delivery of this document to the CDRRHR within sixty (60) days will be accepted.
   • Amendment Version For radiation devices used for medical applications, a Medical Device Registration Certificate (CMDR) or Medical Device Notification Certificate (CMDN) issued by FDA-CDRRHR must be submitted to the Bureau of Customs (BOC) for Class B, C, and D medical radiation devices prior to release, replacing the requirement for a CFCR.
2. Merging of Sections V.C.1 and V.D.1:
   • The two sections have been combined and amended to include additional types of radiation devices. All importers or Marketing Authorization Holders (MAH) must provide a CMDR or CMDN for specific medical radiation devices when submitting import entries.
3. Accessories and Software Requirements:
   • Accessories and software intended for use with medical radiation devices must have a Medical Device Notification Certificate (CMDN) or CMDR before release. However, radio frequency (RF) coils for MRI, x-ray tubes, and other parts specifically used to produce radiation still require a CFCR
4. Special Guidance:
   • Medical radiation devices intended for research, clinical studies, and donations must submit a Certificate of Medical Device Listing (CMDL) from CDRRHR before importation. Furthermore, medical radiation devices that are part of foreign donations must seek FDA clearance
5. Transition Period:
   • According to FDA Circular No. 2021-002-B, CFCR and License to Operate (LTO) for medical device businesses can still be submitted and approved until March 31, 2023. Starting April 1, 2023, all MAH holders for Classes B, C, and D medical radiation devices must apply for a CMDN.

For further details, please refer to FDA Circular No.2017-013-A I AMENDMENT TO FDA CIRCULAR NO. 2017-013