FDA CIRCULAR 
No. ____________ 
S
UBJECT : AME NDMENT TO 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)”  
I. B
ACKGROUND
F
DA Circular No. 2017-013: “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) ”, was issued
to rationalize  the guidelines for the regulation of the importation of radiation devices
used for both medical and non -medical applications.  The issuance intended to provide
regulatory action while the FDA is in the process of developing guidelines for medical
device registration.
O
n January 2018, DOH Administrative Order No. 2018-0002 entitled , “Guidelines
Governing the Issuance of an Authorization for a Medical Dev ice based on the ASEAN
Harmonized Technical Requirements ” was issued to provide guidelines on the
documentary requirements for the registration of medical devices based on theprovisions of the ASEAN Medical Device Directive through a phased implementation
specified through FDA Circular No. 2021-002 and its  amendments .
As su
ch, an amendment of  the provisions of  FDA Circular No. 2017-013 is needed to
align with DOH AO No. 2018 -0002 . Specifically, all medical radiation devices shall
also be classified in accordance with the agreed classification of the ASEANConsultative Committee on Standards and Quality – Medical Device Product Working 
Group (ACCSQ -MDPWG). The registration of such devices shall also be covered and
regulated by the specific and procedural guidelines of the AO .
I
n view thereof, this amendment aims  to provide for the updated guidelines for the
customs release of imported medical radiation devices  harmonizing with current
processes for other devices  regulated by the FDA.
DRAFT 
  
II. OBJECTIVES 
 
This Circular aims to align  and amend FDA Circular No. 2017-013  with provisions  of 
DOH AO No. 2018 -0002 and provide guidelines for medical radiation devices  in line 
with the phased implementation  of the AO  specified through FDA Circular No. 2021 -
002 and its amendments . 
 
III. SCOPE  
 
This Circular  shall apply to  all importers  of radiation devices  used for medical  and non-
medical applications.  
 
IV. GUIDELINES  
 
To align with the full implementation of DOH AO No. 2018-0002 through FDA 
Circular No. 2021-002, the following Sections of  FDA Circular No. 2017-013 are 
hereby amended:  
 
A. Section V.A.6 : 
 
From  To 
For a radiation device item to be used for 
medical applications, a Certificate of 
Product Registration (CPR) or any 
equivalent document certifying that the 
product is safe and allowed to be sold in the country of origin 
issued by the 
Ministry of Health of the country of 
origin; 
 
a. This document shall be duly 
authenticated by the Philippine 
Consulate in the country of origin ; 
 
b. If the CPR is unavailable 
immediately, a duly notarized 
letter guaranteeing submission of this document to the CDRRHR, within sixty (60) days from receipt by the CDRRHR of t
he written 
request, shall be allowed in lieu of 
the CPR.  For radiation devices used for medical 
applications, a Certificate of Medical 
Device Registration (CMDR)  / 
Certificate of Medical Device 
Notification (CMDN) issued by the 
FDA -CDRRHR shall be submitted to 
the Bureau of Customs (BOC) for Class 
B, C, and D medical radiation devices prior to its  release, 
in lieu of the 
Clearance for Customs Release 
(CFCR). 
DRAFT 
  
B. Section s V.C.1  and V.D.1 are amended and combined into a single provision with 
the inclusion of  additional types of radiation devices  :  
 
From  To 
Section  V.C.1  
 
Pursuant to Customs Memorandum Order 
No. 9 -2015 dated 10 April 2015 entitled 
''On the Strict Enforcement of Rules 
Concerning Regulated Imports ," all 
importers shall be required to provide a CFCR for radiation devices listed below when filing import ent ries with the BOC: 
 
1. Radiation Devices used for 
Medical Applications  
a. Computed Tomography (CT) 
Dental X -ray Machine 
b. Conventional X -ray Machine 
c. Dental Conventional X -ray 
Machine 
d. Dental panoramic X -ray 
Machine 
e. Dental Radiography X -ray 
Machine 
f. Electron Microscope  
g. Laser Pointer (Laser for 
Medical, Ophthalmolog y & 
Dental Purpose)  
h. Linear Accelerator  
i. Mammo graphy X -ray 
Machine 
j. Medical CT X -ray Machine 
k. Mobile X -ray Machine 
l. Potable X -ray Machine 
m. Transportable X -ray Machine  
n. Tomotherapy Machine  
o. UV/Laser (for Dermatology  
 
Section V.D.1  
 
Radiation devices listed below are also 
regulated imports and are  Pursuant to Customs Memorandum 
Order No. 9 -2015 dated 10 April 2015 
entitled “ On the Strict Enforcement of 
Rules Concerning Regulated Imports ” 
and the updated List of BOC regulated 
imports, all importers, or Marketing 
Authorization Holder (MAH), as 
defined by FDA Circular No. 2021-002-
A, shall be required to provide a CMDR  
or CMDN  for medical radiation devices 
listed below when filing import entries with the BOC:  
 
a. Conventional X -ray Machines  
b. Dental Panoramic X-ray Machines  
c. Laser Pointers (Laser for 
Medical, Ophthalmological, & 
Dental Purposes)  
d. Medical Computed 
Tomography (CT) X -ray 
machines  
e. Electron Microscopes  
f. Computed Tomography (CT) 
Dental X -ray Machines  
g. Dental Conventional X -ray 
Machines  
h. Dental Pan oramic X -ray 
Machines  
i. Digital Radiography X -ray 
Machines  
j. UV/Laser Devices (for 
Dermatology or Cosmetic 
Purposes)  
k. Linear Accelerators  
l. Mammography X -ray Machines  
m. Medical Computed 
Tomography (CT X -ray 
Machine)  
DRAFTrequired to have a CFCR from the 
CDRRHR: 
1.Radiation Devices used for
Medical Applications
a. M
agnetic Resonance Imaging
(MRI)
b. Ultrasound Machine
c. Bone Densitometer
d. Interventional X -ray Machinen. Mobile X -ray Machines
o. Portable X -ray Machines
p. Tomoth erapy Machines
q. Transportable X -ray Machines
r. Magnetic Resonance Imaging
(MRI)
s. Ultrasound Machines
t. Bone Densitometers
u. Interventional X -ray Machines
v. Positron Emission Tomography
machines
w. Single photon emission
computed tomography (SPECT)
machines
x. Stereotactic Radiosurgery
Machines
y. Gamma Camera
Other types of medical radiation devices 
not included in the list provided, 
including new technologies or devices, shall also be required a CMDR or 
CMDN  subject to the medical device  
classification 
and verification 
guidelines of DOH AO No. 2018-0002. 
C.S
ection V.E:
From  To 
RF coils for MRI, ultrasound probes or 
transducers, x -ray tubes (and other parts 
or device accessories used for 
replacement of x -ray tube) are required to 
have a CFCR from the CDRRHR prior to 
release of the said regulated imports. 
However, radiation device parts and 
device accessories such as cassettes, 
printers, software. and/or of the same kind shall not be requir ed to have a CFCR from 
the CDRRHR.  Accessories and software  that are 
intended by the manufacturer 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 C ertificate 
of Medical Device Notification 
(CMDN)  or CMDR prior to its release.  
Radiofrequency (RF) coils for MRI, x -
ray tubes, (and other parts used for 
replacement of x -ray tube), and medical 
radiation device  spare  parts  used to 
DRAFT 
 specifically generate radiation  are still 
required to have a CFCR from 
CDRRHR.  
 
 
D. Section V.F  
 
From  To 
For medical devices listed in the FDA 
Memorandum Circular No. 2014-005 and 
its amendments, a CPR is required prior to 
release by the BOC. For exempted 
products, a Certificate of Exemption sha ll 
be required.  Rescinded.  
 
E. Section V. Specific Guidelines additional provisions: 
 
Addition  
 
F. Medical radiation devices  and accessories , regulated under this Circular, 
intended specifically and strictly for research, clinical studies, clinical 
investigations, exhibits, private use of health institutions, sample product for analysis/testing with ongoing CPR application, or donated brand ne w medical 
devices, shall apply for a Certificate of Medical Device Listing (CMDL)  
from CDRRHR prior to importation by the researcher, institution, and/or user 
of such devices.  
 
G. Medical radiation devices  and accessories which is 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 the “ Guidelines in the 
Importation, Facilitation, and Management of Foreign Donations involving Health and health-Related Pr oducts ” shall request for an FDA clearance for 
foreign donations.  
 
 
V. TRANSITORY PROVISIONS  
 
A. The CFCR and the License to Operate (LTO) of the medical device 
establishment shall still be submitted and honored for BOC release  until 31 
March 2023 pursuant to FDA Circular No. 2021-002 -B. 
 
B. Starting 1 April 2023, all Marketing Authorization Holders (MAH) shall apply 
for a CMDN for Class B, C, and D medical radiation devices . While 
DRAFTapplications for CMDN are ongoing, the CFCR and the License to Operate 
(LTO) of the medical device establishment shall still be submitted and honored 
for BOC release provided that a proof of application for  CMD N shall be 
attached to the CFCR and LTO presen ted. 
VI. S
EPARABILITY CLAUSE
A
ll other provisions of FC No. 2017-013 not affected by these changes shall remain valid 
and in effect. In case any section or provision of this Circular or any part thereof, or the application of such section, provision or portion shall be declared invalid, the validity of 
the remaining provisions of this Circular shall not in any way be affected or impaired 
thereby.  
VII. EF
FECTIVITY
Th
is Circular shall take effect after fifteen (15) days following its publication  in a 
newspaper of general circulation and upon filing three (3) certified copies to the University 
of the Philippines Law Center.  
 FRANCISCO T. DUQUE III, MD, MSc  
  Secretary of Health  
DRAFT