 
 
                                                                                                                                                                                                                                                                                                                                                                                                                      
 
 Republic of the Philippines  
Department  of Health 
OFFI CE OF THE SECRETARY  
 
Building I, San Lazaro  Compound , R izal Av·enue, Sta .Cruz, 1003 Mani  la • Trunk  Line  651-7800 • Direct Line: 7 1 1-9501 
Fa x: 743-1829, 743-1786 • URL: http://www.doh.gov.ph  • e-mail: osec@doh.gov.ph   
 
 
ADMINISTRATIVE ORDER  
No. _______ __________  
 
                   SUBJECT :   Guidelines on  the Labeling  Requirements  for Medical Devices  
in the Philippines  
 
I. RATIONALE  
  
             The Food and Drug Administration (FDA) through the Center for Device 
Regulation, Radiation Health and Research (CDRRHR) is the primary agency 
authorize d to enforce regulatory requirements  on manufacture, importation,  
distribution , sale, and offering for sale of medical devices in accordance with the 
provis ions of Republic Act 9711 also known as FDA Act of 2009, and its Implementing 
Rules and Regulations (IRR). As stipulated in the IRR, the CDRRHR is mandated  to 
establish an effective regulatory system and mechanism to ensure the safety , quality  
and performance  of medical devices in the Philippines.  
 
              The Philippines as a signatory to the ASEAN Agree ment on Medical Device 
Directive (AMDD), adheres to continuously harmonize the technical procedures and 
requirements to reduce diversity in t he regulations of medical device s. 
 
              The issuance of the guidelines on labeling requirements for medical devices, 
serves to communicate safety instructions related to information to users and/ or 
patients, as well  as to standardize the require d policy, and to assure the highest quality 
of medical device s used in the country.  
 
II. OBJECTIV E 
 
             This Administrative Order aims to provide guidelines on the labeling  
requirements  for medical devices  align ed with the provisions of the ASEAN Medical 
Device Directive .  
 
III.      SCOPE  
 
             This guideline shall apply to all medical device s including In -vitro diagnostic 
(IVD) medical devices  that are marketed and or sale in the Philippines . 
 
IV. DEFINITION OF TERMS  
 
For the purpose of this Administrative Order , the term below shall be  defined  as 
follows:  
 
1. Contraindications  - means a general description of the disease or condition and the 
patient population for which the medical device should not be used for the purpose 
of diagnosing, treating, curing or mitigating.  Contraindications are conditions under  
 which the medical device should not be used because the risk of use clearly 
outweighs any possible benefit.  
 
2. Custom -Made  Medical Device  - means a medical device that: 
 
a. is made at the request of qualified practitioner (QP) and in accordance with the 
specifications of QP regarding the design characteristics or construction of the 
medical device;  
b. is intended to be used only in relation to a particular individual; and  
c. is not adapted from a mass -produced medical device.  
 
3. Healthcare Professional  - a person with proficient skill and experience with the 
use of medical device so that they can aid or train care patients and caregivers to 
use and maintain the quality and performance of the health product.  
 
4. Instruction For Use (IFU) / Patient Information Leaflet (PIL)  - Information 
provided by the product owner to inform the medical device user/ and or patients 
of the product’s proper use and of any precautions to be taken.  
 
5. Intended Purpose/ Intended Use  - means the use for which the medical device is 
intended, for which it is suited according to the data supplied by the product owner 
in the instructions as well as the functional capability of the medical device.  
 
6. In-Vitro Diagnostic (IVD) Medical Device  - refers to any   reagent, reagent 
product, calibrator, control material, kit, instrument, apparatus, equipment or 
system, whether used alone or in combination, intended by the product o wner  to be 
used for  the examination  of specimens, including blood or tissue donation, derived 
from the human body solely or principally for the purpose of   
 
a. providing information concerning a physiological or pathological state or;  
b. providing information concerning a congenital abnormality; or  
c. determining the safety and compatibility with potential recipients; or  
d. monitoring therapeutic measures.  
 
7. Label  - Written, printed or graphic information provided upon the medical device 
itself. Where physical constraints prevent this happening, this term includes 
information provided on the packaging of each unit or on the packaging of multiple 
medical devices.  
 
 
8. Labe ling - The label, instructions for use, and/or any other information that is 
related to identification, technical description, intended purpos e and proper use of 
the medical device s but excluding shipping documents.  
 
9. Lay person  - An individual who does not have formal training in a relevant field 
or discipline.  
  
10. Medical Device - means any instrument, apparatus, implement, machine, 
appliance, implant, in vitro reagent or calibrator, software, material or other similar 
or related article :   
  
 intended by the manufacturer to be used, alone or in combination, for human 
beings for one o r more of the specific purpose /s of 
 
- diagnosis, prevention, monitoring, treatment or alleviation of   disease;  
- diagnosis, monitoring, treatment, alleviation of or compensation  for an 
injury;  
- investigation, replacement, modification, or support of the   anatomy or of 
a physiological process;  
- supporting or sustaining life;  
- control of conception;  
- disinfection of medical devices;  
- providing information for medical device or diagnostic purposes by  means 
of in vitro examination of specimens derived from the hu man body; and  
 
 which does not achieve its primary intended action in or on the human body by 
pharmacological, immunological or metabolic means, but which may be 
assisted in its intended functions by such means.  
 
11. Near patient  - beside the patient, or immediately the  patient  bedside.  
 
12. Primary Level of Packaging  - the first level of  packaging  in direct contact/ attached 
to the medical device . 
  
13. Product Name  - refers to the nam e of the medical device s registered in the FDA . 
 
14. Precaution s - It alerts the user to exercise special care necessary for the safe and 
effective  use of the medical device. It  may include actions to be taken to avoid effects 
on patients/users that may not be potentially life - threatening or result in serious 
injury, but about which the us er should be aware.  
 
15. Product Owner - in relation to a medical device,  means any person who:  
        
a. supplies the medical device under his own name, or under any trade mark, design, 
trade name or other name or mark owned or controlled by him; and  
 
b. is responsible for designing, manufacturing , assembling, processing, label ing, 
packaging, refurbishing or modifying the medical device, or for assigning to it a 
purpose, whether those tasks are performed by him or on his behalf.  
   
16. Qualified Practitioner  (QP)  - A physician or a health care professional  who is 
qualified by education, training licensure/ regulation (when applicable) and facility 
privileging (when applicable) who performs a professional service within his/ her 
scope of practice and independently reports that professional service.  (AMA)  
 
17. Reagent  - Any chemical, biological or immunological components, solutions or 
preparations intended by the product owner to be used as IVD medical devices.  
  
 18. Refurbished Medical Device  - refers to a medical device that was previously  owned and 
reconditioned for re -sale and meets the safety and performance parameters set by the 
manufacturers.  
 
19. Research Use O nly - is where the medical device is made available to 
institutions/laboratories subject to studies intended for collation of data only. The 
product is not intended for any medical purpose or objective.  
 
20. Single Use Device  - means the medical  device  is intended to be used in an individual 
patient during a single procedure and then disposed of. It is not intended to be 
reprocessed and re -used.  
 
21. Secondary Level of Packaging  - means the second layer of packaging of the 
medical device .  
 
22. User  - the person, either professional or lay, who uses a medi cal device. The patient 
can be a user.  
 
23. Warnings  - This is the specific hazard alert information that a user needs to know 
before using the medical device.  
 
V. GENERAL GUIDELINES  
 
1. The label shall be appropriately located depending  on a particular medical device 
and its intended use, in accordance with the following forms:  
 
a. As far as it is practical and appropriate, the information needed to identify and 
use the medical device safely shall  be provided on the medical device itself. If 
this is not practicable or appropriate, some or all of the information may appear 
on the pack aging for each unit (primary level of packaging), and / or on the outer 
packaging of multiple medical devices that are packaged together (secondary 
level of packaging);  
 
b. if individual packaging of each unit is not practicable or app ropriate, the 
informatio n shall  be set out in the instructions for use (IFU)  see Annex A  (e.g. 
leaflet, packaging insert, manual or other supplied  media ); and  
 
c. where the product owner supplies multiple medical devices to a single user and/or 
location, it may be sufficient and appropriate to provide with them only a single 
copy of the instructions for use. In these circumstance s the medical device user 
shall  have access to further copies upon request.  
 
2. The medium, format, content, readability  and location of labeling shall  be 
appropriate to the particular medical device, its intended purpose and the technical 
knowledge, experience, education o r training of the intended user/s . In particular, 
instructions for use should be written in terms readily understood by the intended 
user and, where appropriate, supplemented with drawings and diagrams. Some 
medical devices may require separate information for the healthca re professional and 
the lay person . 
  
 3. Instructions for Use (IFU) may not be needed or may be abbreviated for medical 
devices of low or moderate risk if they can be used safely and as intended by the 
product owner without any such instructions.  
 
4. Paper versions / hard copies  of all labeling shall  accompany the medical device.   
 
5. Any residual risk identi fied in the risk analy sis shall  be reflected as 
contraindications, precautions or warnings within the labeling.  
 
6. The use of internationally recognized symbols is encouraged provided that medical 
device safety is not compromised by a lack of understanding on the part of the pat ient 
or user. Where the meaning of the symbol is not obvious to the medical device user 
e.g. for a lay -user or for a newly introduced symbol, an explanation should be 
provided.  
 
7. All characters on labeling shall  be of adequate of size and legibly printed.  
 
8. The product labeling  shall  be written in English and/ or Filipino.     
 
9. The color contrast between labeling and package background, designs shall  not 
obscure information.  
 
10. For medical device  software, user instructions shall  be supplied  in electronic data 
storage device like compact disc, digital video disc or USB flash drive / or other 
media . 
 
11. For information downloadable f rom the internet, the internet web address shall  be 
clearly printed on the physical label of the device and displayed in such a manner 
that highlights  its purpose to the user . The product owner shall  ensure that the 
electronic label is identical in content to the paper format (where applicable) that is 
submitted with the product registration application. Users a nd/or other relevant 
parties shall  also have access to a paper version of the IFU upon request.  
 
12. The label shall not contain any statement  to the effect, whether directly or indirectly, 
that the placement in the market , or usage or operation of the medical device is being 
promoted or endorsed by the Department of Health – Food  and Drug Administration, 
or any of its organizational bodies.  
 
VI. SPECIFIC GUIDELINES  
 
A. Medical Devices  
              The following specific content of labeling that shall appear in  the packaging  
for medical devices : 
 
1. Product name,  trade name  or brand name to permit the user to identify  the 
medical device . 
 
2. Name, address  and contact details  (e.g. phone number , and website address to 
obtain technical assistance) of the product owner . 
  
 3. Certificate of Medical Device Notification N umber or C ertificate of Medical Device 
Registration  number  issued  by the FDA -CDRRHR on all levels of packaging.  
 
4. Name and address of the importer and /or distributor. It is mandatory to all levels of 
packaging unless the sterility  and self -life will be compromise d.  
 
5. Sufficient details for the user to identify the medical device and,  where these are not 
obvious, its intended purpose, user and  patient popul ation of the medical device; 
also, where relevant, the  contents of any packaging.  
 
6. Batch code, lot number  or the serial number , if applicable.  
 
7. Expiration date  expressed at least as year and month  (e.g. 2020 -NOV), if applicable.  
 
8. Special storage/container, handling condition s and /or storage conditions.  
  
9. Manufactu ring date expressed at least as year and month . 
 
10. The information needed to verify whether the medical device is properly installed 
and can operate correctly and safely, including details of the n ature, and frequency 
of preven tive and regular maintenance, where relevant any quality control, 
replacement of consumable components, and calibration needed to ensure that the 
medical device operates properly and safely during its  intended life, if applicable  
 
11. The performance intended by the product owner and, where relevant, any 
undesirable side effects.  
 
12. Details of any further treatment or handling needed before the medical device can 
be use d (e.g. sterilization, final assembly, calibration, preparation of reagents and/ 
or control materials, etc.) where relevant.  
 
13. Identification for “sterile  medical device ” and where appropriate,  the sterilization 
method (e.g. sterilized using aseptic processi ng techniques;  sterilized using ethylene 
oxide; sterilized using irradiation and/or steriliz ed using steam or dry heat); the 
information about what to do if the s terile packaging is damage d; and instructions 
for re-sterilization , if applicable.  
 
14. Identification  for “single -use only” medical device  as specified by the product 
owner.  
 
15. Identification for “reusable  medical device ”, information on the appropriate 
processes to allow reuse, in cluding cleaning, disinfection, packaging and, where 
appro priate, the method of re -steriliz ation and any restriction on the number of 
reuses.  
 
16. The requirement s for sterilization  of a medical device before it used and instructions 
for cleaning and sterilization process.  
 
17. Indication for “refurbished ” medical devic e and the date of refurbishment shall be 
indicated .   
  
18. Identification for a “custom -made ” medical device and a sta tement that it shall be 
used by a qualified practitioner .  
 
19. If the medical device is intended for “clinical investigation ” or, for IVD medical 
devices, “performance evaluation  only”, an indication  of that situation.  
 
20. It shall b e labeled if the medical device  is intended for “research use only” and 
for “presentation or demonstration purposes only ”: not use on humans.   
 
21. If the medical device is intended  for research use  only, it must be labelled as 
“research use only”.  
 
22. Particular risks in connection with implantation of an “implantable ” medical 
device.  
 
23. If the medical device “emits radiation ” for medical purposes,                                                                                                                                                                                                                                                                                                                                                    
where the details of the nature, type and where appropriate, the intensity and 
distribution of this radiation  shall  be indicated . A radiation symbol on the specific  
part of the medical device  where the radiation source will be originated  (e.g. x -
ray tube)  shall  be also labeled .   
  
24. Information regarding the “risks of reciprocal interference ” posed by the 
reasonably foreseeable presence of the medical device during specific 
investigations, evaluations, treatment or use (e.g. electromagnetic interference 
from other equipment).  
 
25. If the medical device is to be installed with or connected to other  medical devices 
or equipment, or with dedicated software, in order to operate as required for its 
intended purpose, sufficient details of its characteristics to identify the correct 
medical devices or equipment to use in order to obtain a safe combination . 
 
26. IVD medical device shall be labeled as “In-vitro diagnostic ” or “IVD” 
 
B. In- vitro Diagnostic Medical Devices  
In addition to the  information required in Specific Guidelines - A. Medical 
Devices , directions/ instructions  for the proper use of IVD medical device shall  
contain the following:     
 
a. For HIV test kit, a stick -on label indicating “For DOH accredited laboratory use 
only” as per Republic Act No: 5804.  
 
b. Intended purpose, with the followin g information:  
 
i. Type of analyte or measurand  of the assay.  
ii. Whether the test is quantitative or qualitative.  
iii. Role of the test in the clinical use e.g. screening, diagnostic or detection, 
aid to diagnostic, monitoring.  
iv. Disease or condition that the test is intended for. 
v. Type of specimen to be used e.g. serum, plasma etc.   
 vi. The intended users (e.g. self -testing by lay person, near patient  by trained 
personnel or professionals).  
vii. Assay type e.g. immunoassay, chemistry, cytochemistry, image analysis, 
immunohistochemistry.  
viii. The specific name of the instru ment required for the assay, if  any. 
ix. For instruments, the intended purpose should also include the modes of 
operation for instruments e.g., random access, batch, stat, open tube, closed 
tube, automatic, manual.  
 
c. Test principle.  
 
d. Specimen type.  
 
e. Conditions for collection, handling,  storage and preparation of the  specimen.  
 
f. Reagent description and any limitation (e.g. use with a dedicated instrument only).  
 
g. The metrological traceability of values assigned to calibrators and trueness -control 
materials, including identification of applicable reference materials and/or 
reference measurement procedures of higher order.  
 
h. Assay procedure including calculations and interpretation of   results.  
 
i. Inform ation on interfering substan ces that may affect the   performance of the 
assay.  
 
j. Performance characteristics (summarized analytical and diagnostic sensitivity, 
specificity, reproducibility, etc.)  
 
k. Reference intervals.  
 
l. Study design (population stud ies, N, type of sample, matrix, dilution , target 
concentrations, etc.). 
 
VII. TRANSITORY  
 
          All medical devices upon the effectivity  of this A .O. prior to introduction for 
sale, distribution, and marketing shall comply with this A .O. All those alre ady in the 
market shall not be affected by this A.O . 
 
VIII.  PENALTY  
 
         Any violation of this Administrative Order consistent with Republic Act No. 
3720 and Republic Act No. 9711 and its implementing rules and regulations shall be 
a ground for filing appropriate administrative charges and/or imposition of 
administrative sanctions such as, but not limited to, imposition of fines, suspension, 
cancellation or revocation of any license, permit or registration issued by FDA.  
 
  
 IX. REPEALING AND SEPARABILITY CLAUSE  
 
            All administrative  orders, rules and regulations and administrative issuances 
or parts thereof inconsistent with the provision of this order are hereby repealed or 
modified accordingly.  
 
             If any provision in this Administrative Order, or application of such prov ision 
to any circumstances, is held invalid, the remainder of the provisions in this 
Administrative Order shall not be affected.  
 
X. EFFECTIVITY  
 
  This Administrative order shall take effect after fifteen (15) days 
following its   publication in two (2) newspapers of national circulation and upon filing 
to the University of the Philippines Law Center -Office of the National Administrative . 
 
 
 
 
 
 Signed  
                                           Secretary of Health  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 Annex A  
 
For medical devices where an instruction for use (IFU)/ patient information leaflet 
(PIL) is applicable, the followi ng additional information shall  be contained therein:  
 
a. Date of issue or latest revision of the instructions for use and, where    
appropriate, a n identification number.  
 
b. Precautions and/or measures to be taken in the event of changes   in the 
performance, or malfunction, of the medical device including a contact 
telephone number, if appropriate.  
 
c. Precautions and/or measures to be taken as regards exposure, in  reasonably 
foreseeable environmental conditions, to magnetic  fields, external electrical 
influences, electrostatic discharge,  pressure or variations in pressure, 
temperature, humidity,  acceleration, thermal ignition sources, proximity to 
other  medical  devices, etc.  
 
d. If the medical device administers medicinal products, adequate  information 
regarding any medicinal product(s) which the medical  device in question is 
designed to administer, including  any limitations in the choice of substances 
to be delivered.  
 
e. Any medicinal substances or biological material incorporated into  the 
medical device as an integral part of the medical device.  
 
f. If the medical device has a measuring function, the degree  of accuracy 
claimed for it.  
 
g. Any requirement for speci al facilities, or special training, or  particular 
qualifications of the medical device user and/or third  parties.  
 
h. Any precautions to be taken related to the disposal of the medical  device 
and/or its accessories (e.g. lancets), to any consumables  used with  it (e.g. 
batteries or reagents) or to any potentially  infectious substances of human or 
animal origin.  
 
i. Where relevant, for medical devices intended for lay persons  a statement 
clearly directing the user not to make any decision of  medical relevance 
without first consulting his or her health care  provider.  
 
j. For further information, an electronic copy of IFU / PIL  or the Quick 
Response ( QR) code shall  be   available online through manufacturer’s 
website written on the packaging.  
 
k. Where relevant, for devices intended for home users, the IFU should contain 
a statement clearly directing the user not to make any decision of medical 
relevance without first consulting his or her health care provider.  
 