final draft of the new sets of guidelines for the registration of medical device products, edited...

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20 June 2014 2

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ADMINISTRATIVE ORDER 4 No. 2014 - _______________ 5

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SUBJECT:The New Documentary Requirements for the Registration of Medical 8

Device Products 9 10

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I. Rationale 12 13

The fast evolution of medical technology and the importance of medical devices in the health 14

care delivery system have awakened the regulators to look more into the safety and effectiveness 15

of these devices through regulation while facilitating trade among the ten member states of the 16

Association of Southeast Asian Nations (ASEAN). Structured and regionally accepted technical 17

requirements were developed by the ASEAN member states through the ASEAN Consultative 18

Committee on Standards and Quality – Medical Device Product Working Group (ACCSQ-19

MDPWG). The development of the common submission dossier template (CSDT) was a 20

concerted effort of all the member states taking into consideration the global technical 21

requirements developed by the Global Harmonization Task Force. 22

23

The CSDT is a set of technical requirements for the registration of the medical device products 24

agreed by the ten ASEAN member states. The Philippines is committed to align the regulatory 25

guidelines with this set of technical requirements, thus the development of this administrative 26

order. 27

28

II. Declaration of Policy 29 30

Pursuant to Republic Act No. 9711, the Food and Drug Administration Act of 2009, and its 31

implementing rules and regulation, this Administrative Order is formulated to govern the new 32

documentary requirements for the registration of medical device products. 33

34

III. Objective 35 36

The new documentary requirements are hereby promulgated to align the Philippine medical 37

device regulatory requirements to the common submission dossier template as agreed upon by 38

the ten (10) member countries under the ASEAN, as part of the ASEAN Medical Device 39

Directive. 40

41

IV. Scope 42 43

The new documentary requirements shall apply to all medical devices to be sold, imported, 44

exported, manufactured, and used in the Philippines, except in-vitro diagnostic and refurbished 45

medical devices, for both of which separate Administrative Orders shall be issued. 46

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V. Definition of Terms 2 3

For the purpose of this Administrative Order, the terms below shall be defined as follows: 4

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1. Applicant – refers to a local establishment, either a manufacturer, trader, distributor/importer/ 6

exporter applying for CMDN, CMDL, and/or CMDR. 7

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2. Center for Device Regulation, Radiation Health and Research (CDRRHR) – refers to the 9

regulatory office under the Food and Drug Administration (FDA) of the Department of 10

Health (DOH) that is in-charge of the regulation of medical devices in the Philippines. 11

12

3. Certificate of Medical Device Notificaton (CMDN) – refers to the authorization issued to a 13

medical device that complies with all the requirements for Notification of a medical device. 14

The CMDN is issued to medical devices that will fall under class A. 15

16

4. Certificate of Medical Device Registration (CMDR) – refers to the authorization issued to a 17

medical device that complies with all the requirements for Registration of a medical device. 18

The CMDR is issued to medical devices that fall under classes B, C, and D. 19

20

5. Certificate of Listing (CL) – refers to the authorization issued to a medical device that is 21

intended for research, clinical trial, exhibit, donation, etc that is not intended for sale. 22

23

6. Common Submission Dossier Template (CSDT) - is a set of technical requirements agreed 24

upon by the ten member countries of the ASEAN which shall govern the regulation of 25

medical devices in the ASEAN. 26

27

7. Country of origin – refers to the country where the device is manufactured or where the 28

device has been registered and/or has been issued a market approval prior to distribution in 29

the Philippines. 30

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8. Distributor/importer/exporter - means any establishment that imports or exports raw 32

materials, active ingredients and/or finished products for its own use or for wholesale 33

distribution to other establishments or outlets. 34

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9. Distributor/wholesaler - means any establishment that procures raw materials, active 36

ingredients and/or finished products from local establishments for local distribution on a 37

wholesale basis. 38

39

10. Inspection – refers to the on-site validation of the facility, records and any other pertinent 40

documents in the possession of a person or business that manufactures, distributes, stores or 41

sells medical devices. 42

43

11. In-Vitro Diagnostic Medical Device – refers to any reagent, reagent product, calibrator, 44

control material, kit, instrument, apparatus, equipment or system whether used alone or in 45

combination, intended by the manufacturer to be used in-vitro for the examination of 46

specimens, including blood and tissue donation, derived from the human body solely or 47

principally for the purpose of providing information: 48

a. concerning a physiological or pathological state; or 49

b. concerning a congenital abnormality; or 50

c. to determine the safety and compatibility with potential recipients; or 51

d. to monitor therapeutic measures. 52

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12. License to Operate (LTO) – refers to the authorization issued by the FDA to a person or 1

establishment to operate as a manufacturer, trader, distributor/importer/exporter/wholesaler 2

of medical devices. 3

4

13. Listing - is the process of seeking authorization to use medical device products for research, 5

clinical trial, exhibit, donation, etc., that are not intended for sale. 6

7

14. Manufacturer – refers to an establishment engaged in any and all operations involved in the 8

production of medical device including preparation, processing, compounding, formulating, 9

filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view 10

of its storage, sale or distribution. 11

12

15. Medical Device – mean any instrument, apparatus, implement, machine, appliance, implant, 13

in vitro reagent and calibrator, software, material or other similar or related article: 14

15

intended by the manufacturer/product owner to be used, alone or in 16

combination, for human beings for one or more of the specific purpose(s) of:- 17

- diagnosis, prevention, monitoring, treatment or alleviation of disease, 18

- diagnosis, monitoring, treatment, alleviation of or compensation for an injury, 19

- investigation, replacement, modification, or support of the anatomy or of a 20

physiological process, 21

- supporting or sustaining life, 22

- control of conception, 23

- disinfection of medical devices, 24

- providing information for medical or diagnostic purposes by means of in vitro 25

examination of specimens derived from the human body; and 26

which does not achieve its primary intended action in or on the human body by 27

pharmacological, immunological or metabolic means, but which may be 28

assisted in its intended function by such means, 29

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15. Notification – is the process of seeking authorization to manufacture, import, export, sale 31

and/or distribute Class A medical devices in the Philippines. 32

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16. Person – refers to any individual, partnership, corporation, association and/or organization. 34

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17. Product Standards – refers to medical device standards set, formulated, developed and/or 36

established by any of the following: 37

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a. Bureau of Product Standards (Philippine National Standard), 39

b. International Standardization Organization (ISO), 40

c. International Electrotechnical Commission (IEC), 41

d. Other International Standard Bodies recognized by the DOH 42

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or any foreign standards that may be recognized by the DOH for the purpose of registration. 44

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18. Refurbished Medical Device – refers to a medical device that was previously owned and 46

reconditioned for re-sale and meets the safety and performance parameters set by the 47

manufacturer. 48

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19. Registration –means the process of approval of an application to register medical device prior 50

to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, 51

transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of 52

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medical device products. 1

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20. Safety – means that the product will not impose any danger, injury, damage or undesirable 3

effect to a person at the preset condition intended for the use of the medical device. 4

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21. Trader – means any establishment which is a registered owner of a medical device and 6

procures the raw materials and packing components and provides the production monographs, 7

quality control standards and procedures, but subcontract the manufacture of such product to a 8

licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing 9

of its products. 10

11

VI. Classification of Medical Devices 12 13

The classification system of medical devices in this Administrative Order shall follow the 14

classification system as agreed by the Medical Device Product Working Group under the 15

ASEAN Consultative Committee on Standards and Quality which is rule-based and according to 16

the level of risk. The classification to be used shall be Class A, B, C, and D, where class A is the 17

classification for the low risk medical devices and class D for the highest risk medical devices. 18

The classification rules shall be based on the ASEAN Medical Device Directive. The CDRRHR 19

shall issue a listing of medical devices per classification. 20

21

The CDRRHR shall be authorized to reclassify certain devices when the level of risk of the 22

device is changed by a certain incident in the manufacture, distribution or use of the device upon 23

proper consultation with the advisory committee set forth by the Philippine FDA and/or the 24

ASEAN for this purpose 25

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VII. Policies 27 28

1. The applicant shall classify the device based on the list of medical devices per classification 29

issued by the CDRRHR. If the product is not included in the list, the company shall classify 30

the device based on the intended use and on the classification rules of the ASEAN Medical 31

Device Directive. The CDRRHR shall verify the classification made by the applicant and 32

shall reclassify the device if another classification is deemed to be more appropriate. 33

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2. All medical devices under class A shall apply for notification of medical device product, 35

while all medical devices under classes B to D shall apply for registration of medical device 36

product. 37

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3. An application shall be made separately per specific medical device. In case of the following 39

conditions, only one application can be filed; however, separate product certification/s shall 40

be issued: 41

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medical device with accessories that are intended to be sold separately, 43

medical device manufactured in multiple manufacturing sites and shall co-exist in the 44

market, 45

medical device system where the use of one part of the system is needed to be used 46

together with all or any part of the system 47

medical devices with the same intended use and the same manufacturing process but 48

differ in one or more raw materials 49

medical devices with the same intended use and the same manufacturing process but 50

differ in the design 51

5

medical devices with the same raw materials but differ in types or shapes resulting in 1

different specific intended use. 2

3

The registration fee for this type of application shall be equivalent to the total registration fee 4

for all the individual products that will be registered. 5

6

The applicant shall follow the FDA Memorandum Circular no. 2013-001: Guidelines on the 7

Submission of LTO and CPR application with electronic copy (e-copy) and its subsequent 8

amendments and implementing guidelines. 9

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4. The Notification Number or Registration Number shall be issued to the device with approved 11

CMDN or CMDR. 12

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5. The CMDN shall be valid for five (5) years as long as there is no change in the composition, 14

packaging, process, and components of the device and shall be renewed every five (5) years 15

after the initial approval. When the distributor/manufacturer of the device ceased the 16

production or distribution of such device, the CDRRHR shall be informed in writing within 17

thirty (30) calendar days. 18

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6. The initial CMDR shall be valid for five (5) years and shall be renewed every five (5) years 20

after the initial approval. The CDRRHR can require the revalidation of the CMDR anytime 21

within the five(5) year validity period to ensure the continuous compliance of the applicant 22

with the regulation. 23

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7. Filing for the renewal of the certificates of registration or notification shall be accepted 25

within ninety (90) calendar days prior to the expiry date of the CMDR or CMDN. 26

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8. Applications for renewal of certificates of registration or notification filed after the validity 28

date shall be imposed with corresponding penalty in accordance with the existing rules and 29

regulations on fees and charges. An application for renewal filed after one hundred twenty 30

(120) calendar days shall not be accepted and shall be considered as initial application. 31

Medical devices with expired validity and whose application was turned into an initial 32

application shall cease the selling of such device until such time that the certification of 33

product registration is approved. The applicant can, however, opt to request the retention of 34

the product registration/notification number. 35

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9. Follow-up on the status of the application shall only be entertained after the date indicated on 37

the company’s receiving copy. The status of the application shall be posted in the FDA 38

website. 39

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10. All applications with deficiencies in the submission shall be given a maximum of ninety (90) 41

calendar days to comply. Only one time compliance shall be accepted. Applications with 42

non-compliances shall be disapproved. A re-application can be submitted within sixty (60) 43

calendar days after disapproval. However, if after the re-application, there is still a non-44

compliance, the application shall be considered disapproved. If no compliance document is 45

received within the set compliance period, the application shall be automatically considered 46

disapproved. 47

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11. The list of all approved CMDRs and CMDNs shall be posted in the FDA website. 49

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12. Medical devices strictly for research, clinical trial, exhibit, and/or donated brand new medical 51

devices are exempted from Notification and Registration. However, the researcher, 52

institution and/ or user of such devices shall apply for a Certificate of Listing. 53

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13. The CDRRHR reserves the right to ask for any other requirements not indicated in this Order 2

but deemed necessary to support the reliability and authenticity of the submitted documents 3

and safety of the medical device product; or that may arise based on the submitted 4

compliance documents. 5

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14. Disapproved applications shall be returned to the applicant. In case the applicant does not 7

claim the disapproved applications within 90 calendar days, the application documents shall 8

be destroyed and discarded. 9

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15. An approved application issued a certificate of product registration number shall place in the 11

label of the medical devices the following national labeling requirements prior to sale and 12

distribution of the medical device products. 13

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a. Name and address of the importer 15

b. Name and address of the distributor (if exclusive distributor) 16

c. Certificate of Product Registration number 17

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The national labeling requirements shall be placed in all layers of the packaging. It shall be 19

placed in the label of the immediate packaging when sold individually to the product user 20

and/or for over-the-counter (OTC) products. If the space of the label of the immediate 21

packaging is limited, at least the certificate of product registration number shall be placed. 22

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VIII. Documentary Requirements 24 25

A. The following are the requirements for the application for the Notification of medical 26

devices under Class A. 27 A.1 National Legal Requirements 28

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1.1 Notarized e-copy affidavit (Annex A) 30

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1.2 Notarized Application Form (Annex B) 32

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1.3 Photocopy of the valid License to Operate in the Philippines issued by FDA 34

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1.4 Proof of payment or order of payment 36

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1.5 For distributors, the Certificate of Agreement between the Manufacturer and Distributor 38

regarding the device; for imported medical devices, the Certificate shall be duly 39

authenticated by the territorial Philippine consulate 40

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1.6 Government certificate attesting to the status of the Manufacturer ‘s competency and 42

reliability of the personnel and facilities or Quality Systems Certificate of approval or 43

compliance certificate with ISO 9000 series or ISO 13485. For imported medical 44

devices, the Certificate shall be duly authenticated by the territorial Philippine Consulate 45

46

1.7 For imported medical devices, Certificate of Product Notification or Certificate of 47

Product Registration or any equivalent document attesting to the safety and effectiveness 48

of the device issued by the regulatory agency/accredited notified body in the country of 49

origin and duly authenticated by the territorial Philippine Consulate. Free sales 50

certificate shall not be accepted. 51

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1.8 Representative sample or commercial presentation of the product, when needed, and a 1

color picture of the device 2

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A.2 Technical Requirements in accordance with the Common Submission Dossier Template of 4

the ASEAN Medical Device Directive 5

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2.1 Device description consisting of the following: 7

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a. Intended use 9

b. Instruction for use 10

c. List of all raw materials 11

d. Technical specification of the finished product 12

e. List of reference codes, sizes, colors, models and variance, whichever is 13

applicable. 14

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2.2 Sterilization method and sterility test done on the device. 16

2.3 Certificate of Conformity to the aspect of manufacture relating to metrology for devices 17

with measuring functions. 18

2.4 Declaration of Conformity (self declaration by the manufacturer) with product standards, 19

if applicable 20

2.5 Sample of labels on the device and its packaging and other labeling materials to be used 21

for the device that includes user’s or instruction manuals. 22

2.6 Stability studies of the product to justify claimed shelf-life, if applicable 23

24

B. The following are the requirements for Initial Registration of medical devices under 25

class B in accordance with the CSDT template: 26 27

B.1 National Legal Requirements 28

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1.1 Notarized e-copy affidavit (Annex A) 30

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1.2 Notarized Application Form (Annex C) 32

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1.3 Photocopy of the valid License to Operate in the Philippines issued by FDA 34

35

1.4 Proof of payment or order of payment 36

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1.5 For distributors,a Certificate of Agreement between the Manufacturer and Distributor 38

regarding the device; for imported medical device, the Certificate shall be duly 39

authenticated by the territorial Philippine consulate 40

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1.6 Quality Systems Certificate of approval on Manufacturing or compliance certificate with 42

ISO 9000 series or ISO 13485. For imported medical device, the Certificate shall be duly 43

authenticated by the territorial Philippine Consulate. 44

45

1.7 For imported medical devices,a Certificate of Product Notification or Certificate of 46

Product Registration or any equivalent document attesting to the safety and effectiveness 47

of the device issued by the regulatory agency/accredited notified body in the country of 48

origin and duly authenticated by the territorial Philippine Consulate 49

50

1.8 Representative sample or commercial presentation of the product, when needed, and 51

colored picture of the device 52

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B.2 Technical Requirements in accordance with the Common Submission Dossier Template of 2

the ASEAN Medical Device Directive 3

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2.1 Executive Summary 5

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2.2 Relevant essential principles and method/s used to demonstrate conformity, if 7

applicable. The evidence of conformity should indicate the specific document. (see 8

Annex L) 9

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2.3 Device description consisting of the following: 11

12

a. Intended use 13

b. Indications of use/Instruction of use 14

c. Contraindications 15

d. Warnings 16

e. Precautions 17

f. Potential adverse effects 18

g. Alternative therapy (practices and procedures) 19

h. Materials. A description of the materials of the deviceand their physical 20

properties to the extent necessary to demonstrate conformity with the relevant 21

Essential Principles.. The information shall include complete chemical, 22

biological and physical characterization of the materials of the device. 23

24

i. Other Relevant Specifications to include the following: 25

26

- The functional characteristics and technical performance specifications of 27

the device including as relevant: accuracy, sensitivity specificity of measuring 28

and diagnostic medical devices, reliability and other factors 29

30

- If applicable, other specifications including chemical, physical, electrical, 31

mechanical, biological, software, sterility, stability, storage and transport, and 32

packaging. 33

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j. Other Descriptive Information to demonstrate conformity with the relevant 35

Essential Principles (e.g. biocompatibility category) 36

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2.4 Summary of Design Verification and Validation Documents: 38

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a. Validation documents consisting of the following: 40

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Declaration/Certificates of Conformity to the “recognized standards”issued 42

by the manufacturer 43

44

Summaries or reports of tests and evaluation based on other standards, 45

manufacturer methods and tests, or alternative ways of demonstrating 46

compliance, such as 47

a listing of and conclusions drawn from published reports that 48

concern the safety and performance of aspects of the medical 49

device with reference to the Essential Principles; 50

51

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data summaries or tests reports and evaluations covering any of the following 1

appropriate test reports, whichever is applicable: 2

- Engineering test 3

- Laboratory test 4

- Biocompatibility test 5

- Animal Test 6

- Simulated Use 7

- Software Validation 8

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Pre-clinical studies 10 11

b. Medical Device Labeling –Sample of labels and its packaging 12

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c. Risk Analysis to include the results, when applicable 14

15

B.3 Physical Manufacturer information 16

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3.1 Manufacturing process, including quality assurance measures. This should 18

include the manufacturing methods and procedures, manufacturing environment 19

or conditions, facilities and controls. The information may be presented in the 20

form of a process flow chart showing an overview of production, controls, 21

assembly, final product testing, and packaging of finished medical device. 22

3.2 A brief summary of the sterilization method should be included. 23

24

C. The following are the requirements for initial registration of medical devices under 25

class C. 26 27

1. All of the requirements of class B, except for number 6 of B.2 and pre-clinical studies 28

29

2 . Risk assessment consisting of risk analysis, evaluation and reduction measures. 30

31

3. Clinical evidence for the following: 32

33

a. Implantable devices 34

b. Newly introduced devices 35

c. Devices incorporating new materials coming into contact with the patient. 36

d. Existing materials applied in a body part not previouslyexposed to that material, and 37

for which no prior chemical experience exists. 38

e. An existing device that is modified and the modification might affect safety and 39

effectiveness. 40

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4. Software validation studies, if applicable. 42

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5. Biological evaluation, if applicable. 44

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D. The following are the requirements for the initial registration of medical devices under 46

class D. 47 48

1. All requirements for class C, except item number 3. 49

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2. Clinical evidence 51

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3. List of counties where the device has been sold. 53

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4. A summary of all studies on which the manufacturer relies to ensure that the device meets 2

the safety and effectiveness. 3

4

5. A bibliography of all published reports dealing with the use, safety, and effectiveness of 5

the device. 6

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6. Objective evidence (study) on biological safety of the device, if the device contains animal 8

or human tissue or their derivatives. 9

10

E. The following are the requirements for the renewal of notification/registration of 11

medical devices for all classifications. 12 13

1. Notarized e-copy affidavit (Annex A) 14

15

2. Notarized Application Form(Annex B or C) 16

17

3. Photocopy of the valid License to Operate in the Philippines issued by FDA. 18

19

4. Photocopy of previous CMDR. 20

21

5. Proof of payment or order of payment. 22

23

6. Quality Systems Certificate of approval or compliance certificate with ISO 9000 series or 24

ISO 13485. For imported medical device, the Certificate shall be duly authenticated by 25

the territorial Philippine Consulate. 26

27

7. For distributors, Certificate of Agreement between the Manufacturer and Distributor 28

regarding the device involved. For imported medical device the Certificate shall be duly 29

authenticated by the territorial Philippine consulate. 30

31

8. Sample of commercial labels and its packaging and other labeling materials use for the 32

device that includes user’s or instruction manuals 33

34

9. Color picture of the product 35

36

F. The following are the requirements for the Certificate of Listing 37

38 1. Notarized Application Form (Annex D) 39

40

2. Notarized letter addressed to the Director, Center for Device Regulation, Radiation Health 41

and Research, stating that the medical device will be used solely for personal use, 42

research, analysis, exhibit, or is being donated by a certain organization and is not 43

intended for sale. The letter should contain the following information: 44

45

a. Complete list of the devices indicating the brand and the name of the 46

manufacturer of the product 47

b. Declaration that the organization will be the sole entity responsible for the 48

medical devices and that the CDRRHR-FDA, DOH will not be held liable for any 49

safety issue concerning the product. 50

51

11

3. Certificate of Product Notification or Certificate of Product Registration or any equivalent 1

document attesting to the safety and effectiveness of the device issued by the regulatory 2

agency in the country where the device will come from. 3

4

4. For a donated medical device, a certified true copy of the deed of donation and deed of 5

acceptance. 6

7

5. Copy of bill of lading, proforma invoice, or official receipt of purchase. 8

9 6. Copy of SEC or DTI registration, when applicable. If for personal use, copy of proof of 10

residence. 11

12

IX. Evaluation Process 13 14

The application shall be evaluated within one hundred eighty (180) days upon filing of the 15

applications. All applications that do not comply with the technical requirements shall be 16

notified through a letter and shall be given a one-time chance to correct the deficiencies within 17

ninety (90) days. If the applicant still fails to comply with the requirements, he/she will be given 18

a chance to re-apply, with a corresponding fee, and to submit the complete compliance 19

documents within sixty (60) days. Failure to comply with the required documentation within the 20

given period shall be a ground for disapproval of the application. 21

22

X. Issuance of Certificates 23 24

The certificate of medical device notification (CMDN), certificate of medical device registration 25

(CMDR), and Certificate of Listing (CL) shall be issued by the CDRRHR upon the approval of 26

the Center Director or his/her authorized representative, if the application is found to be 27

meritorious; otherwise, the application shall be disapproved. The initial or renewed CMDN and 28

CMDR shall be valid for five (5) years. 29

30

XI. Fees and Charges 31 32

The schedule of fees and charges shall follow the existing fees and charges for medical device 33

registration issued by the Food and Drugs Administration. 34

35

XII. Implementation 36 37

This administrative order shall be implemented as follows: 38

39

1. The administrative guideline shall initially cover all registrable products listed in 40

FDA Memorandum Circular No. 2014-005: Updated List of Medical Devices 41

required to be registered prior to sale, distribution and use. The CDRRHR shall 42

release the list of medical devices per classification based on the classification set 43

forth in the ASEAN Medical Device Directive. 44

45

2. The coverage of registration shall be extended to all medical devices not indicated 46

in the list of registrable medical devices by phases. The schedule of 47

implementation shall be issued in separate memoranda. The phases are listed as 48

follows: 49

50

Phase 1: Notification of Class A 51

Phase 2: Registration of Class D 52

12

Phase 3: Registration of Class B and Class C 1

2

3. All medical device establishments, including medical device retailers, shall submit 3

through on-line submission the complete list of medical devices that they distribute, 4

manufacture, import, repack, re-label, and/or export within one (1) year upon the 5

effectivity of this Guideline. 6

7

XIII. Sanctions 8 9

The following are the grounds for disapproval, cancellation, revocation and/or non-renewal of 10

CMDNand CMDR: 11

12

1. The manufacture, sale, offering for sale or transfer of device that does not meet all the 13

requirements of safety and effectiveness. 14

15

2. Misrepresentation or concealment of significant data or information about the product 16

sought to be registered; 17

18

3. Alteration, mutilation, destruction, obliteration or removal of any part of labeling; 19

20

4. Medical device that has a biological, chemical or physical property that may cause an 21

unacceptable health risk; 22

23

5. Submission of falsified document(s); 24

25

6. Alteration or falsification of issued CMDN or CMDR. 26

27

XIV Confidentiality of Information 28 29

Any officers and employees of CDRRHR shall not make public or use for their own personal 30

gain any trade secret or proprietary information which they obtain or become familiar with 31

during the course of their official duties. Any official caught shall be dealt with in accordance 32

with the existing sanctions. 33

34

XV Repealing Clause 35 36

All administrative orders, rules and regulations and administrative issuances or parts thereof 37

inconsistent with the provision of this order are hereby repealed or modified accordingly. 38

39

XVI Effectivity 40 41

This order shall take effect immediately after publication in a newspaper of general circulation. 42

The implementation of the registration of medical devices following the new set of regulatory 43

requirements shall be one (1) year upon the effectivity of this Administrative Order. However, 44

medical device establishments may voluntarily submit earlier their application using the new set 45

of requirements. 46

47

48

49

50

ENRIQUE T. ONA, MD 51 Secretary of Health 52

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ANNEX A 6

7 ELECTRONIC COPY (E-Copy) AFFIDAVIT 8

9 10

REPUBLIC OF THE PHILIPPINES 11 PROVINCE OF _____________ 12 MUNICIPALITY OF __________ 13 14 I, Mr./Ms._________________________, of legal age, single/married), is the (position)_________ and 15 authorized representative of the company____________________ with registered business address 16 at____________________________________________, after being sworn in accordance with law, depose and say: 17 18

a. That in the application for a License to Operate(LTO)/Certificate of Product Registration(CPR), I hereby 19 submit the necessary requirements (hardcopy) prescribed by the Food and Drug Administration including 20 the electronic/scanned copy (soft copy) in PDF Searchable Format at least 300 dpi on a DVD-R ; 21 22

b. That the attached electronic copy of the LTO/CPR application requirements/ records/dossier is the exact 23 duplicate of the hardcopy submitted to FDA; 24

25 c. That under no circumstances shall I submit, copy/transfer any unauthorized files, codes, scripts (including 26

but not limited to viruses or worms), documents and information. 27 28

d. Further state that any discrepancy/prejudicial contents or willful misrepresentation on any of the data in the 29 electronic copy of the LTO/CPR application requirements/records against the hardcopy shall be a ground 30 for disapproval of the application and/or legal action for perjury against me or any of the responsible 31 person/s in our company/establishment. 32 33

e. That upon return of the hard copy, we shall keep the hard copy for 5 years and/or as long as the 34 establishment and/or the product remains active in the market and the hard copy shall be made available 35 for audit/retrieval as determined by the FDA. 36 37 I declare under oath that the foregoing statement composed of one (1) page is true, correct and complete to 38

the best of my knowledge and belief. 39 IN WITNESS WHEREOF, I have hereunto set my hand this day of _____________,2013, in the 40

Municipality of ______________, Province of ______________, Philippines. 41 42

Respectfully submitted: 43 44

_______________________________________ 45 SIGNATURE ABOVE PRINTED NAME 46 _____________ _________________ 47 DESIGNATION DATE 48

49 NOTARY PUBLIC 50

Doc. No.__________________ 51 Book No.__________________ 52 Page No.___________________ 53 Series of___________________ 54

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Subscribed and sworn to before me this ____ day of ________ 201____ . 57 58

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ANNEX B 6 7 TO THE DIRECTOR For CDRRHR Use only

Center for Device Regulation,

Radiation Health, and Research Control Number:

Food and Drug Administration

Department of Health Date Received:

8 9 Sir/Madam: 10 11 In Accordance with R.A. 9711 and other related issuances, we wish to apply for the ( ) initial ( ) renewal 12 notification of our product. 13 14

APPLICATION FOR MEDICAL DEVICE NOTIFICATION 15 16 17

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35 Pharmacist (when the regulatory officer is not a Pharmacist): 36 37

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41 42 43 We hereby certify that the foregoing information and all other data submitted in connection with this application are 44 true and correct. We understand that the failure to report all required information or submission of false or 45 misleading information is an offense punishable by law. We certify that we have examined the following statements 46 and we attest to their accuracy: 47 48

1. The Current Good Manufacturing Practice Guidelines for Medical Device is applied in full in the 49 manufacture of this product. 50

2. The manufacturing procedure is exactly as specified in the submitted manufacturing process. 51

Device Name:

Device Propriety/Brand Name

Model/Reference Number/Property Code/Item Code:

Intended Use of Device:

Applicant’s Company Name:

Address:

Tel No. Fax. No. E-mail address:

Company President/General Manager:

Regulatory Officer:

Legal Manufacturer(Product Owner):

Address:

Actual Manufacturer:

Address:

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3. The product covered by this declaration will not undergo any change in the formulation, size, 1 reference number, use, manufacturer, manufacturing process, labeling or commercial presentation 2 without prior approval of this office. 3

4. Each batch of the finished product is tested and certified to be fully compliant with the specifications 4 in the accompanying documentation. 5

5. The person releasing the product for sale is an authorized and/or qualified person. 6 6. The procedures for control of the finished product have been validated. 7 7. The market authorization holder has a standard operating procedure for handling any adverse event 8

related to the use of the device. 9 8. The market authorization holder has a standard operating procedure for handling product recalls. 10 9. All the documentation referred to in this application is available for review during comprehensive 11

inspection of the establishment. 12 10. We shall change the brand name so submitted should the proper authority decides with finality that 13

we have no right to appropriate and utilize the said brand name; and 14 11. We shall acknowledge and agree to indemnify and/or hold FDA free and harmless against any and 15

all third party claims arising from the acceptance of such brand name of the product for registration 16 with FDA. 17

12. The product covered by this declaration will not undergo any change in the ownership, registrant’s 18 address/location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing 19 process (if applicable), labeling or commercial presentation, and packaging of the product covered 20 by this certificate of notification without prior approval of this office. 21

13. We acknowledge and agree that in the event that there is an unauthorized change in the ownership, 22 its address/location, manufacturer, ingredients, formulation, size, reference number, use, 23 manufacturing process (if applicable), labeling or commercial presentation, and packaging of the 24 product: 25

i. CDRRHR may automatically suspend the LTO and/or CPR of the product; 26 ii. We will voluntarily recall the product from the market; and 27

iii. We will indemnify and/or hold CDRRHR free and harmless against any and all third 28 party claims and/or actions pertaining to the above unauthorized change(s). 29

30 31 Regulatory Officer:

SIGNATURE OVER PRINTED NAME

Owner/General Manager:


Government ID Number:


Date Issued: Date Issued:

Place Issued Place Issued

32 33 34 SUBSCRIBED AND SWORN before me this __________ day of _________ affiant exhibiting to me his/her 35 Community Tax Certificate indicated above. 36

37 Doc. No. ________ 38 Page No. ________ 39 Book No. ________ 40 Series of ________ 41

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ANNEX C 6 7 TO THE DIRECTOR For CDRRHR Use only





8 9 Sir/Madam: 10 11

In Accordance with R.A. 9711 and other related issuance’s, we wish to apply for the ( ) initial ( ) renewal 12 registration of our product. 13 14

APPLICATION FOR MEDICAL DEVICE REGISTRATION 15 16

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36 Pharmacist (when the regulatory officer is not a Pharmacist): 37 38

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44 45 We hereby certify that the foregoing information and all other data submitted in connection with this 46 application are true and correct. I understand that the failure to report all required information or submission of false 47 or misleading information is an offense punishable by law. We certify that we have examined the following 48 statements and we attest to their accuracy: 49 50


Address:


Company Owner/General Manager:

Regulatory Officer:


Address:


Address:

Device Name:

Device Propriety/Brand Name:


Classification

Class B Class C Class D

Device’s Intended Use:

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1. The Current Good Manufacturing Practice Guidelines for Medical Device is applied in full in the 1 manufacture of this product. 2

2. The manufacturing procedure is exactly as specified in the submitted manufacturing process. 3 3. Product covered by this declaration will not undergo any change in the formulation, size, reference 4

number, use, manufacturer, manufacturing process, labeling or commercial presentation without 5 prior approval of this office. 6

4. Each batch of the finished product is tested and certified to be fully compliant with the specifications 7 in the accompanying documentation. 8

5. The person releasing the product for sale is an authorized and/or qualified person. 9 6. The procedures for control of the finished product have been validated. 10 7. The market authorization holder has a standard operating procedure for handling any adverse event 11

related to the use of the device. 12 8. The market authorization holder has a standard operating procedure for handling product recalls. 13 9. All the documentation referred to in this application is available for review during comprehensive 14

inspection of the establishment. 15 10. We shall change the brand name so submitted should the proper authority decides with finality that 16

we have no right to appropriate and utilize said brand name; and 17 11. We shall acknowledge and agree to indemnify and/or hold FDA free and harmless against any and 18

all third party claims arising from the acceptance of such brand name of the product for registration 19 with FDA. 20

12. Product covered by this declaration will not undergo any change in the ownership, registrant’s 21 address/location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing 22 process (if applicable), labeling or commercial presentation, and packaging of the product covered 23 by this certificate of notification without prior approval of this office. 24

13. We acknowledge and agree that in the event that there is an unauthorized change in the ownership, 25 its address/location, manufacturer, ingredients, formulation, size, reference number, use, 26 manufacturing process (if applicable), labeling or commercial presentation, and packaging of the 27 product: 28

iv. CDRRHR may automatically suspend the LTO and/or CPR of the product 29 v. We will voluntarily recall the product from the market; and 30

vi. We will indemnify and/or hold CDRRHR free and harmless against any and all third 31 party claims and/or actions pertaining to the above unauthorized change(s). 32

33 34 Regulatory Officer:








35 36 SUBSCRIBED AND SWORN before me this __________ day of _________ affiant exhibiting to me his/her 37 government ID Number indicated above. 38

Doc. No. ________ 39 Page No. ________ 40 Book No. ________ 41 Series of ________ 42 43

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ANNEX D 7 TO THE DIRECTOR For CDRRHR Use only





8 Sir/Madam: 9 10

In Accordance with R.A. 9711 and other related issuance’s, we wish to apply for the listing of our product. 11 12

APPLICATION FOR MEDICAL DEVICE LISTING 13 14

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37 I hereby certify that the foregoing information and all other data submitted in connection with this 38 application are true and correct. I understand that the failure to report all required information or submission of false 39 or misleading information is an offense punishable by law. 40 41

Regulatory Officer/Company Representative:








42


Address:


Company Owner/General Manager:

Regulatory Officer/Company Representative:


Address:


Address:

Device Name:

Device Propriety/Brand Name


Classification:

Class A Class B Class C Class D

Intended Use of Device:

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SUBSCRIBED AND SWORN before me this __________ day of _________ affiant exhibiting to me his/her 1 government ID indicated above. 2

3 Doc. No. ________ 4 Page No. ________ 5 Book No. ________ 6 Series of ________ 7