Supreme Court E-Library
Information At Your Fingertips

  View printer friendly version

The  fast  evolution  of  medical  technology  and  the  essential  role  of  medical devices in the health care delivery system have highlighted the importance of ensuring the safety and effectiveness of these devices through regulation while facilitating  trade among the ten member states of the Association  of Southeast Asian  Nations  (ASEAN).  Structured  and  regionally  accepted  technical requirements were developed through the ASEAN Consultative Committee on Standards and Quality — Medical Device Product Working Group (ACCSQ- MDPWG).

The development  of the common  submission  dossier  template  (CSDT)  was  a
‘combined  effort  of  the  ASEAN  member  states  taking  into  consideration  the global  technical  requirements   developed  by  the  Global  Harmonization   Task Force.  The CSDT  is a set of technical  requirements  for the registration  of the medical device products agreed upon by the ten ASEAN member countries. The Philippines is committed to align its regulatory guidelines with this set of technical requirements, thus the issuance of this Administrative Order.

Pursuant to Republic Act No. 9711, the Food and Drug Administration (FDA) Act of 2009 and its implementing  Rules and Regulations  (IRR), this Administrative Order (A0) is being issued to govern the new sets of documentary requirements for the registration of medical device products.


This Order aims to provide guidelines on the documentary requirements for the registration  of medical devices and to align the registration  requirements  to the CSDT based on the provisions ofthe ASEAN Medical Device Directive.


The new documentary requirements shall apply to all medical devices to be sold, imported, exported, manufactured, and used in the Philippines, except in—vitro diagnostic and refurbished medical devices, for which separate Administrative Orders shall be issued.


For the purpose of this Administrative Order, the terms below shall be defined as follows:

1.  Applicant  —  refers  to  any  individual,  partnership,  corporation,  association, and/or organization, either a manufacturer, trader, distributor/importer/ exporter applying for a CMDN, a CMDL, and/or a CMDR as defined below.

2. Authorization  - refers to any certification issued to the applicant by CDRRHR showing the product has complied on documentary  and technical requirements such as Notification and Registration with certificate.

3. Center for Device Regulation, Radiation Health and Research (CDRRHR) — refers to the regulatory office under the Food and Drug Administration  (FDA) of the Department  of Health (DOH) that is in charge  of the regulation  of medical devices in the Philippines.

4.      Certificate   of   Medical   Device   Notification   (CMDN)   —   refers   to   the authorization issued for a medical device that complies with all the requirements for Notification of a medical device. The CMDN is issued for medical devices that will fall under class A.

5. Certificate  of Medical  Device  Registration  (CMDR)  — refers  to the authorization issued for a medical device that complies with all the requirements for Registration  of a medical  device. The CMDR  is issued for medical  devices that fall under classes B, C, and D.

6.   Certificate  of Medical Device Listing (CMDL) —- refers to the authorization issued for a medical device that is intended for research, clinical trial, exhibit, donation, etc. and that is not intended for sale.

7. Common Submission Dossier Template (CSDT) - is a set of technical requirements  agreed  upon  by the ten member  countries  of the ASEAN  which shall govern the regulation of medical devices in the ASEAN.

8.  Country of origin — refers to the country where the device is manufactured or where the device has been registered and/or has been issued a market approval prior to distribution in the Philippines.

9. Distributor/importer/exporter - means any medical device establishment that imports or exports raw materials, active ingredients  and/or finished products for its own use or for wholesale distribution to other establishments or outlets.

10.     Distributor/wholesaler   -  means  any  medical  device  establishment   that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on a wholesale basis.

11.  In-Vitro Diagnostic 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 manufacturer to be used in-vitro for the examination of specimens, including blood and 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.

12.  Legal Manufacturer —means any foreign medical device establishment with responsibility  for the design,  manufacture,  packaging  and labeling  of a device before  it is placed  in the market  under  his own  name,  regardless  of whether these operations are carried out by that person himself or on his behalf by a third party.

13. License to Operate (LTO) — refers to the authorization issued by the FDA to a person or establishment to operate as a manufacturer, trader, distributor/importer/exporter/wholesaler of medical devices.

14. Manufacturer  — refers to any medical device establishment  engaged in any and all operations involved in the production of a medical device including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting,  finishing and labeling with the end in View of its storage, sale or distribution.

15. Medical Device — means any instrument, apparatus, implement, machine, appliance,  implant,  in  vitro  reagent  and  calibrator,  software,  material  or  other similar or related article:

-  intended by the manufacturer/product owner to be used, alone or in combination, for human beings for one or 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 or diagnostic purposes by means of in vitro examination  of specimens  derived from the human 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 function by such means.

16.  Medical Device System — is composed of different medical devices wherein each device is essential in the operation of the system.

17.  Notification  —-  is  the  process  of  seeking  authorization  to  manufacture, import, export, sell and/or distribute Class A medical devices in the Philippines.

18. 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, labelling, 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.

19. Product Standards — refers to medical device standards set, formulated, developed, and/or established by any of the following:

a. Bureau of Product Standards (Philippine National Standard), b. International Organization for Standardization (ISO),
c. International Electrotechnical Commission (IEC),
d. Other International Standard Bodies recognized by the DOH, or
e. Any foreign  standards  that may be recognized  by the DOH  for the purpose of registration.

19.     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 manufacturer.

20. Registration — means the process of approval of an application to register medical  device  prior  to engaging  in the manufacture,  importation,  exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of medical device products.

21. Trader — means any local establishment  that is a registered product owner of a medical device, procures the raw materials and packing components, and provides the production monographs,  quality control standards and procedures, but subcontracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.


1. The classification system of medical devices in this Administrative Order shall follow the classification  system as agreed on by the ACCSQ-MDPWG  which is rule based and according to the level of risk listed below:

Class	Risk Level
A	Low
B	Low-Moderate
C	Moderate-High
D	High

A   guidance   document   containing   the   list   of   medical   devices   per classification  shall be issued. Reclassification  of certain devices can be done when the level of risk of the device is changed by a certain incident in the manufacture,  distribution or use of the device. This shall be done upon proper consultation with the advisory committee created by the Philippine FDA and/or the ASEAN for this purpose.

2. The applicant shall classify the device based on the list of medical devices per classification issued by the CDRRHR. If the product is not included in the list, the company shall classify the device based on the intended use and on the classification  rules of the ASEAN Medical Device Directive. The CDRRHR shall verify the classification made by the applicant and shall reclassify the device if another classification is deemed to be more appropriate.

3. All medical  devices  under class A shall apply for notification  of the medical device product, while all medical devices under classes B to D shall apply for registration of the medical device product.

4. The Notification Number or Registration Number shall be issued to the device with an approved CMDN or CMDR. The CMDN and the CMDR shall be valid for five (5) years and shall be renewed every five (5) years after the initial approval.

5. The distributor/local manufacturer of the device shall inform the CDRRHR in writing Within thirty (30) calendar days in case the distributor/local  manufacturer has ceased the production or distribution of such device.

6.  The  list  of  all  approved  CMDRs  and  CMDNs  shall  be  posted  in  the  FDA website.

7. Medical devices strictly for research, clinical trial, exhibit, and/or donated brand new medical devices are exempted from Notification and Registration. However, the  researcher,   institution,  and/  or  user  of  such  devices  shall  apply  for  a Certificate of Medical Device Listing.

8.    The  CDRRHR  reserves  the  right  to  ask  for  any  other  requirements  not indicated in   this Order but deemed necessary to support the reliability and authenticity   of  the  submitted  documents   and  safety  of  the  medical  device product; or that may arise based on the submitted compliance documents.

9.    Disapproved  applications  shall  be  returned  to  the  applicant.  In  case  the applicant does not claim the disapproved  applications  within 90 calendar days, the application documents shall be destroyed and discarded.


1. An application  shall be made separately  for each specific medical device. In case  of  the  following  conditions,  only  one  application  can  be  filed;  however, separate certificates of product registration shall be issued:

a. a medical device with accessories wherein the accessories are intended to be sold separately,

b. a medical device, owned by the same legal manufacturer, that is manufactured in different manufacturing  plants and will be both distributed at the same time in the Philippine market,

c. a medical  device  system  where  the use of one part of the system  is needed to be used together with all or any part of the system,

d.  medical  devices  with  the  same  intended  use  and  the  same manufacturing process but differ in one or more raw materials,

e.  medical  devices  with  the  same  intended  use  and  the  same manufacturing process but differ in the design,

f. medical devices with the same raw materials but differ in types or shapes resulting in different specific intended use.

2.   The registration  fee for application  meeting the abovementioned  condition/s shall be equivalent to the total registration fee for all the individual products that will be registered.

A. Initial

1. All applications with deficiencies shall be given a one-time compliance period of a maximum of ninety (90) calendar days. If the deficiencies were not complied during the compliance period, the application shall be considered disapproved. However,  the  applicant  may  opt  to  submit  a  re-  application  within  sixty  (60) calendar days after the disapproval. If no compliance is received within the set compliance  period,  the  application  shall  be  automatically  considered disapproved.

2. Product labels of the medical devices with issued CMDR or CMDN shall have the following national labeling requirements prior to sale and distribution:

a. Name and address of the importer
b. Name and address of the distributor (if exclusive distributor)
c. CMDN number or CMDR number.

3. Documentary Requirements

a. The list of requirements for the Notification of Class A medical devices & Registration   of  Classes  B,  C  and  D  medical  devices  are  as  follows (attached as Annexes):

a.1 Annex A — Legal Requirements for Application for the Notification of Medical  Devices  under  Class  A  and  Registration  of  Medical  Devices under Classes B, C and D

a.2   Annex   B   —   Technical   Requirements   for   Application   for   the Notification of Medical Devices under Class A

a.3  Annex  C —  Technical  Requirements  for the  Initial  Registration  of Medical Devices under Class B in Accordance with the CSDT Template a.4  Annex  D —  Technical  Requirements  for the  Initial  Registration  of Medical Devices under Class C in Accordance with the CSDT Template a.5  Annex  E —  Technical  Requirements  for  the  Initial  Registration  of Medical Devices under Class D in Accordance with the CSDT Template

b.  The  CDRRH  reserves  the  right  to  ask  for  additional  documents  not indicated in this Order that may arise based on the submitted compliance documents

4. The application shall be evaluated within one hundred eighty (180) days upon filing of the applications. All applications that do not comply with the technical requirements  shall  be  notified  through  a letter  and  shall  be  given  a one-time chance to correct the deficiencies within ninety (90) days. If the applicant still fails to comply with the requirements, he/she will be given a chance to re-apply, with a corresponding fee, and to submit the complete compliance documents within sixty(60)days. Failure to comply with the required documentation within the given period shall be a ground for disapproval of the application.

B. Renewal

1. The filing for the renewal of the certificates of registration or notification shall be  accepted  within  ninety  (90)  calendar  days  prior  to  the  expiry  date  of  the CMDR or CMDN.

2. Applications  for renewal of certificates of registration  or notification filed after the validity date shall be fined with the corresponding penalty in accordance with the existing rules and regulations on fees and charges.

3.  An  application  for  renewal  of  CMDR  filed  after  one  hundred  twenty  (120) calendar days after its expiration shall not be accepted and shall be considered an initial application. The distribution and sale of that medical device shall automatically  stop  until  such  time  that  the  certification  of  product  registration have been approved. The applicant can opt, however, to request the retention of the product registration/notification  number.

4. The application  for renewal  shall  be evaluated  within  thirty  (30) days  upon filing of the application. All applications that do not comply with the technical requirements  shall  be  notified  through  a letter  and  shall  be  given  a one-time chance to correct the deficiencies within thirty (30) days.

5. The requirements for the renewal are attached as Annex F, Requirements for the Renewal of Notification/Registration  of Medical Devices for all classifications.

C. Medical Device Listing

1. The filing of application for Medical Device Listing should be made prior to the importation of the medical devices.

2.          The  list  of  requirements  for  Medical  Device  Listing  are  attached  as
Annex G, Requirements for the Application of Medical Device Listing.


The schedule of fees and charges shall follow DOH AO No. 50 s. 2001 and its amendments and revisions.


This A0 shall cover initially all registrable products listed in FDA Memorandum Circular   No.  2014-005:   “Updated   List  of  Medical   Devices   required   to  be registered prior to sale, distribution and use” and its amendments; the Notification of all class A medical  devices;  and the Medical  Device  Listing.  The CDRRHR shall   release   the  list  of  medical   devices   per  classification   based   on  the classification set forth in the ASEAN Medical Device Directive.

The requirement of registration for all medical devices not indicated in the list of registrable medical devices shall be implemented in phases. The schedule of implementation shall be issued in separate memoranda. The phases are listed as follows:

Phase1: Notification of Class B, C and D that are non-registrable  medical devices based on FDA Memorandum Circular No. 2014-005.

Phase 2:  Registration  of  Class  D  (Notification  of  Class  D  shall  cease during this phase)

Phase 3:  Registration  of Class B and Class C (Notification  of classes  B
and C shall cease during this phase)

The  following  are  the  grounds  for disapproval,  cancellation,  revocation  and/or non-renewal of a CMDN and a CMDR:

1. The manufacture, sale, offer for sale, or transfer of a medical device that does not meet all the requirements of safety and effectiveness;

2.  Misrepresentation  or concealment of significant data or information about the product sought to be registered;

3. Alteration, mutilation, destruction, obliteration, or removal of any part of a label‘

4. A medical device that has a biological, chemical or physical property that may cause an unacceptable health risk;

5. Submission of falsified document(s);

6.  Alteration or falsification of an issued CMDN or CMDR.

The sanctions  herein  are in addition  to the appropriate  sanctions  listed  in the
FDA Act of 2009 and its Implementing Rules and Regulations.


The procedure for the filing of Motion for Reconsideration or Appeal shall be in accordance   with   the   provisions   stipulated   in   Republic   Act   9711   and   its Implementing Rules and Regulations.


Any officers and employees  of CDRRHR  shall not make public or use for their own personal gain any trade secret or proprietary information which they obtain or become familiar with during the course of their official duties. Any official who violates this provision shall be dealt with in accordance with the Code of Conduct for Public Officials.


If any portion or provision of this Order is declared invalid or unenforceable or unconstitutional,   the  validity   or  enforceability   of  the  remaining   portions   or provisions shall not be affected, and this Order shall be construed as if it did not contain   the  particular   invalid   or  enforceable   or  unconstitutional   portion   or provision.


FDA  Memorandum  Circular  No.  2014-005,  Updated  List  of  Medical  Devices required  to  be  registered   prior  to  sale  distribution   and  use,  and  all  other issuances inconsistent with the provision of this Order are hereby repealed or modified accordingly.


This  AO  shall  take  effect  fifteen  (15)  days  following  the  completion  of  its publication  in two (2) newspapers  of general  circulation  and filing of three  (3) copies   hereof   to  the  University   of  the  Philippines   Office   of  the  National Administrative Register (UP ONAR).

The implementation of the registration of medical devices following the new set of regulatory requirements shall be one (1) year after the effectivity of this Administrative Order.


The CDRRHR may allow the voluntary submission of applications using the new set of requirements earlier than the indicated implementation of this guidelines.