REGULATORY UPDATE | FDA issues amendment to FDA Circular No. 2017-013, "Guidance on Issuing Clearances for Customs Release (CFCR) of Radiation Devices by the Food and Drug Agency – Center for Device Regulation, Health, and Radiation Research (FDA-CDRRHR)"

The Philippine Food and Drug Administration issued FDA Circular No. 2017-013-A on June 30, 2022, entitled “AMENDMENT TO FDA CIRCULAR NO. 2017-013, ENTITLED, “GUIDELINES ON THE ISSUANCE OF CLEARANCE FOR CUSTOMS RELEASE (CFCR) RADIATION DEVICES BY FOOD AND DRUG ADMINISTRATION – CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH (FDA-CDRRHR)”. 2018-002 as stipulated in FDA Circular No. 2021 -002 and its amendments, and will apply to all imports of radiation devices used for medical and non-medical applications.

FDA Circular No. 2017-013 contains various revisions, including:

‎A. Section V.A.6 V.A.6:‎

• Initial Version Section V.A.6 V.A.6: For radiation devices intended for medical use, you will need to provide a Certificate of Product Registration (CPR) or a similar document confirming that the product is safe and authorized for sale in the country of origin. This document must be approved by the Philippine Consulate in the country of origin. If a CPR is not immediately available, a notarized letter guaranteeing delivery of this document to the CDRRHR within sixty (60) days from the receipt of the written request will be accepted in place of the CPR.
• Amendment Version Section V.A.6 V.A.6: Untuk perangkat radiasi yang digunakan untuk aplikasi medis, ‎‎Sertifikat Pendaftaran Perangkat Medis (CMDR) / Sertifikat Pemberitahuan Perangkat Medis (CMDN) ‎‎yang dikeluarkan oleh FDA-CDRRHR harus diserahkan ke Biro Bea Cukai (BOC) untuk perangkat radiasi medis Kelas B, C, dan D sebelum dirilis, sebagai pengganti Izin untuk Pelepasan Bea Cukai (CFCR).‎‎

B. Sections V.C.1 and V.D.1 have been merged into one provision and amended by means of additional types of radiation devices.

• Initial Version

Section V.C.1: Based on the Customs Memorandum Order No. 9-2015 dated April 10, 2015 entitled “On the Strict Enforcement of Rules Concerning Regulated Imports,” all importers are required to provide CFCR for radiation devices listed below when submitting import entries to the Board of Commissioners:

Radiation Devices Used for Medical Applications

1. Computed Tomography (CT) Dental X-Ray Machines‎
2. Conventional X-Ray Machine
3. Conventional Dental X-Ray Machine
4. Tooth panoramic X-ray machine‎
5. ‎Dental Radiography X-ray Machine
6. Electron Microscope‎
7. ‎Laser Pointer (Laser for Medical, Ophthalmology & Dental Purposes)
8. Linear Accelerator
9. X-Ray Mammography Machine
10. Medical CT X-ray Machine
11. Mobile X-Ray Machine
12. Drinkable X-ray Machine
13. Transportable X-Ray Machine
14. Tomotherapy Machine
15. UV/Laser (for Dermatology)‎

Section V.D.1: Radiation devices listed below are also regulated imports and‎ are required to have a CFCR from CDRRHR:‎

Radiation Devices Used for Medical Applications

1. Magnetic Resonance Imaging (MRI)
2. Ultrasound Machine
3. Transportable X-Ray Machine
4. Ultrasound Machine
5. Mesin Sinar-X Intervensi‎‎

• Section V.C.1 & V.D.1: Based on Customs Memorandum Order No. . 9-2015 dated April 10, 2015 entitled "‎‎On Strict Enforcement of Rules Regarding Regulated Imports‎‎" and an updated list of imports regulated by the Board of Commissioners, all importers, or Marketing Authorization Holders (MAH), as defined by Letter FDA Circular No. 2021-002-A, must provide CMDR or CMDN for medical radiation devices listed below when submitting import entries to the Board of Commissioners:‎

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

C. Section V.A.6 V.E:‎

• Initial Version Section V.A.6: RF coil for MRI, ultrasound probe or transducer, x-ray tube (and other device parts or accessories used for x-ray tube replacement) are required to have a CFCR from CDRRHR before releasing such regulated imports. However, radiation device parts and device accessories such as cassettes, printers, software. and/or of the same type are not required to have a CFCR from CDRRHR.‎

• Amendment Version Section V.A.6: Accessories and software‎‎ intended by the manufacturer for use in combination with medical radiation devices to enable the latter to be used for its intended purpose, and as required by Section VI.1 of DOH AO No. 2018-0002, required to have Medical Device Notification Certificate (CMDN)‎‎ or CMDR‎‎ before release.‎‎ Radio frequency (RF) coils for MRI, x-ray tubes, (and other parts used to replace x-ray tubes), and spare parts of medical radiation devices used to specifically produce radiation are still required to have a CFCR from CDRRHR.‎‎‎‎

D. Section V.A.6 V.F:‎

The amendment process for Section V.F is canceled and is still the same as the contents of the previous circular, namely: For medical devices listed in FDA Memorandum Circular No. 2014-005 and its amendments, BPK REQUIRED before being released by the Board of Commissioners. For exempt products, a Certificate of Exemption will be required.‎

E. Section V. Special Guidance Additional provisions:‎

Addition
Medical radiation devices and accessories, set forth in this Circular, are intended specifically and strictly for research, clinical studies, clinical investigations, exhibitions, personal use of healthcare institutions, sample products for analysis/testing with ongoing CPR applications, or medical devices New donations must submit Certificate of Medical Device Listing (CMDL)‎‎ from CDRRHR before being imported by researchers, institutions, and/or users of the device.‎

Medical radiation devices and accessories that are part of foreign donations to the health sector through the Bureau of International Health Cooperation (BIHC), as defined by DOH AO No. 2020-0001 or "‎‎Guidelines on the Import, Facilitation, and Management of Foreign Donations involving Health and Wellness-Related Products‎‎" must seek FDA clearance for foreign donations.‎‎

According to FDA Circular No. 2021-002-B, CFCR and License to Operate (LTO) of medical device business actors can still be submitted and approved for the release of the Board of Commissioners until March 31, 2023. However, starting April 1, 2023, all Marketing Permit (MAH) holders for medical radiation devices Classes B, C, and D must apply for a CMDN. Although CMDN applications are still being accepted, the CFCR and License to Operate (LTO) of the establishment medical device will be accepted and recognized for release by the Board of Commissioners provided that the CMDN application documentation related to the CFCR and LTO is provided.

Source: FDA Circular No.2017-013-A I AMENDMENT TO FDA CIRCULAR NO. 2017-013