Republic of the Philippines Department of Health OFFICE OF THE SECRETARY JAN 2018 ADMINISTRATIVEORDER No.%9-l;i/- 20l3- 0002 SUBJECT: Guidelines Governingthe Issuance of an Authorization for a Medical Device based on the ASEAN HarmonizedTechnical Requirements
Sec. I. RATIONALE · RATIONALE
RATIONALE The fast evolution of medical technology and the essentialrole 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 developedthrough the ASEAN Consultative Committee on Standardsand Quality — MedicalDeviceProduct Working Group (ACCSQ-MDPWG). The development of the common submission dossier template(CSDT) was a ‘combinedeffort of the ASEAN member states taking into considerationthe global technical requirements developedby the GlobalHarmonizationTask Force. The CSDT is a set of technical requirements for the registration of the medicaldevice productsagreed upon by the ten ASEAN member countries. The Philippines is committed to align its regulatoryguidelines 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 AdministrativeOrder (A0) is being issued to govern the new sets of documentary requirements for the registration of medicaldevice products.
Sec. II. OBJECTIVE · OBJECTIVE
OBJECTIVE This Order aims to provideguidelines on the documentaryrequirements for the registration of medicaldevicesand to align the registrationrequirements to the CSDT based on the provisions of the ASEAN Medical DeviceDirective. Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila Trunk Line 651-7800 local 1113, 08,1135/ DirectLine: 711-9502; 711-9503Fax: 743-1829 URL: http://www.doh.gov.ph; e-mail: officeofsoh a.,do. ov
Sec. III. SCOPE · SCOPE
SCOPE The new documentary requirements shall apply to all medicaldevices to be sold, imported,exported, manufactured, and used in the Philippines, except in—vitro diagnostic and refurbished medical devices, forwhich separate AdministrativeOrders shallbe issued.
Sec. IV. DEFINITION OF TERMS · DEFINITION OF TERMS
DEFINITION OF TERMS For the purpose of this Administrative Order, the terms below shallbe 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 definedbelow. Authorization ~ refers to any certificationissued to the applicant by CDRRHR showing the product has complied on documentary and technical requirements such as Notificationand Registration with certificate. Centerfor Device Regulation, RadiationHealthand 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 devicesin the Philippines. Certificateof Medical Device Notification (CMDN) — refers to the authorizationissued for a medicaldevice that complies with all the requirements for Notification of a medicaldevice. The CMDN is issued for medicaldevices that will fall under class A. Certificateof Medical Device Registration (CMDR) — refers to the authorizationissued for a medicaldevice that complies with all the requirements for Registration of a medicaldevice. The CMDRis issued for medicaldevices that fall under classes B, C, and D. Certificateof Medical Device Listing (CMDL) —- refers to the authorization issuedfor a medicaldevice that is intendedfor research, clinical trial, exhibit, donation, etc. and that is not intended for sale. Common SubmissionDossier Template (CSDT) - is a set of technical requirements agreed upon by the ten membercountries of the ASEAN which shall govern the regulation of medicaldevices in the ASEAN. Country of origin — refers to the country where the deviceis manufactured or where the devicehas been registered and/or has been issued a market approval prior to distributionin the Philippines. Distributor/importer/exporter - means any medicaldeviceestablishment that importsor exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets 10. 11. 12. 13. 14. 15. Distributor/wholesaler - means any medical device establishment that procures raw materials, active ingredients and/orfinished products from local establishmentsfor local distribution on a wholesalebasis. In-Vitro Diagnostic Medical Device — refers to any reagent,reagent product, calibrator, control material,kit, instrument, apparatus, equipment or system whetherused alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens, including blood and tissue donation, derivedfrom the human body solely or principally for the purpose of providing information concerning a physiological or pathological state; or providing information concerning a congenitalabnormality; or determining the safety and compatibility with potential recipients; or monitoring therapeutic measures. 9'.“ 9‘?” Legal Manufacturer —means any foreign medicaldeviceestablishmentwith responsibility for the design, manufacture, packaging and labeling of a device before it is placed in the marketunder his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. 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 medicaldevices. Manufacturer — refers to any medical device establishment engaged in any and all operations involved in the production of a medicaldevice including preparation, processing, compounding, formulating, filling,packing,repacking, altering, ornamenting, finishing and labeling with the end in View of its storage, sale or distribution. 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, forhuman 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 formedical or diagnostic purposes by means of in vitro examination of specimens derivedfrom the human body; and 16. 17. 18. 19. 19. 20. 21. which does not achieveits primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intendedfunction by such means. Medical Device System — is composed of differentmedical deviceswhereineach device is essentialin the operation of the system. Notification —- is the process of seeking authorization to manufacture, import, export, sell and/or distributeClass A medicaldevicesin the Philippines. Product Owner —in relation to a medical device, means any person who: a. supplies themedicaldeviceunder 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, whetherthose tasks are performedby him or on his behalf. ProductStandards — refers to medical devicestandards set, formulated, developed, and/or established by any of the following: Bureau of Product Standards (Philippine National Standard), International Organization for Standardization (ISO), InternationalElectrotechnicalCommission (IEC), Other InternationalStandardBodies recognizedby the DOH, or Any foreign standards that may be recognizedby the DOH for the purpose of registration. sup-99‘s» Refurbished MedicalDevice — refers to a medicaldevicethat was previously owned and reconditionedfor re—sale and meets the safety and performance parameters set by the manufacturer. 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 medicaldevice products. Trader — means any local establishmentthat is a registeredproduct owner of a medical device, procures the raw materialsand packing components, and provides the productionmonographs,quality controlstandardsand procedures, but subcontractsthe manufacture of such product to a licensedmanufacturer. In addition, a trader may also engage in the distributionand/or marketing of its products.
Sec. V. GENERAL GUIDELINES · GENERAL GUIDELINES
GENERAL GUIDELINES 1. The classification system of medicaldevicesin this AdministrativeOrder shall followthe classification system as agreed on by the ACCSQ-MDPWG whichisrule- based and according to the level of risk listed below: Class Risk Level ALow B Low-moderate C Moderate-high D High A guidance document containing the list of medicaldevices per classificationshall 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 consultationwith the advisory committee created by the Philippine FDA and/or the ASEAN forthis purpose. The applicant shall classify the devicebased on the list of medicaldevices per classificationissued 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 MedicalDevice Directive.The CDRRHR shall verify the classificationmade by the applicant and shall reclassify the device if another classification is deemed to be more appropriate. All medical devices under class A shall apply for notification of the medicaldevice product, while all medicaldevicesunder classes B to D shall apply for registration of the medicaldevice product. The NotificationNumber or Registration Number shallbe 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. The distributor/localmanufacturer of the deviceshall inform the CDRRHR in writing Within thirty (30) calendar days in case the distributor/local manufacturer has ceasedthe production or distribution of such device. The list of all approved CMDRs and CMDNs shall be posted in the FDA website. Medical devices strictly for research, clinical trial, exhibit, and/ordonatedbrand new medicaldevices are exempted from Notificationand Registration. However, the researcher, institution, and/ or user of such devicesshall apply for a Certificate of Medical Device Listing. The CDRRHR reserves the right to ask for any other requirements not indicatedin this Order but deemed necessary to support the reliability and authenticity of the submitted documentsand safety of the medicaldevice product; or that may arise based on the submitted compliance documents. Disapproved applications shallbereturned to the applicant. In case the applicant does not claim the disapprovedapplications within calendar days, the application documents shall be destroyed and discarded.
Sec. VI. SPECIFIC GUIDELINES · SPECIFIC GUIDELINES
SPECIFIC GUIDELINES 1. An application shall be made separately for each specific medicaldevice. In case of the following conditions, only one application can be filed; however, separate certificates of productregistration shallbe issued: a. a medicaldevice with. accessorieswhereinthe accessories are intended to be sold separately, b. a medical device, owned by the same legal manufacturer, that is manufacturedin different manufacturingplants andwillbeboth distributed at the same time in the Philippine market, 0. a medicaldevice system where the use of one part of the system is needed to be used together with all or any part of the system, (1. medicaldevices with the same intended use and the same manufacturing process but differ in one or more raw materials, 6. medicaldevices with the same intended use and the same manufacturing process but differ in the design, f. medicaldeviceswith the same raw materialsbut differ in types or shapes resulting in different specific intended use. 2. The registration fee for application meeting the abovementionedcondition/sshallbe equivalent to the total registration fee for all the individual products that will be registered.
Sec. VII. PROCEDURAL GUIDELINES · PROCEDURAL GUIDELINES
PROCEDURAL GUIDELINES A. Initial 1. All applications with deficienciesshall be given a one-time compliance period of a maximum of ninety (90) calendar days. If the deficiencies were not compliedduring 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 withinthe set complianceperiod, the application shallbe automatically considered disapproved. 2. Productlabels of the medicaldevices with issued CMDR or CMDN shall have the following national labeling requirementsprior 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 medicaldevices are as follows (attached as Annexes): a.1 Annex A — Legal Requirements for Application for the Notification of Medical DevicesunderClass A and Registration of Medical Devices under Classes B, C and D a.2 Annex B — Technical Requirements for Application for the Notification of MedicalDevicesunder Class A a.3 Annex C — Technical Requirements for the Initial Registration of Medical Devices under Class B in Accordancewith the CSDT Template a.4 Annex D — Technical Requirements for the Initial Registration of Medical Devices underClass C in Accordance with the CSDT Template a.5 Annex E — Technical Requirements for the Initial Registration of Medical Devices underClass D in Accordance with the CSDT Template b. The CDRRH reserves the right to ask for additional documents not indicatedin 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-timechance 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 submitthe complete compliance documentswithin sixty (60) days. Failure to comply with the required documentationwithin 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 notificationfiled after the validity date shall be fined with the correspondingpenalty in accordance with the existing rules and regulations on fees and charges. 3. An application for renewal of CMDRfiled after one hundred twenty (120) calendar days after its expiration shall not be accepted and shall be considered an initial application. The distributionand sale of that medical deviceshall automatically stop until such time that the certification of productregistration have been approved. The applicant can opt, however, to request the retention of the product registration/notification number. 4. The application for renewalshallbe evaluated within thirty (30) days upon filing of the application. All applications that do not comply with the technical requirements shallbe notified through a letter and shall be given a one-timechance to correct the deficiencies within thirty (30) da 3. w 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. MedicalDevice Listing 1. The filing of application forMedical Device Listing shouldbe made prior to the importation of the medicaldevices. 2. The list of requirements for Medical Device Listing are attached as Annex G, Requirements for the Application of Medical Device Listing.
Sec. VIII. FEES · FEES
FEES AND CHARGES The schedule of fees and charges shall follow DOH AO No. s. 2001 and its amendmentsand revisions.
Sec. IX. PHASES OF IMPLEMENTATION · PHASES OF IMPLEMENTATION
PHASES OF IMPLEMENTATION This A0 shall cover initially all registrableproducts 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 MedicalDevice Listing. The CDRRHR shall releasethe list of medical devices per classificationbased on the classification set forth in the ASEAN Medical DeviceDirective. The requirement of registration for all medicaldevices not indicatedin the list of registrable medicaldevicesshall be implemented in phases. The schedule of implementation shallbe issued in separate memoranda. The phases are listed as follows: 1. Phase 1: Notification of Class B, C and D that are non-registrable medicaldevices based on FDA Memorandum Circular No. 2014-005. 2. Phase 2: Registration of Class D (Notification of Class D shall cease during this phase) 3. Phase 3: Registration of Class B and Class C (Notification of classes B and C shall cease during this phase)
Sec. X. SAN CTIONS · SAN CTIONS
SAN CTIONS The following are the grounds for disapproval, cancellation, revocationand/or non-renewal of a CMDN and a CMDR: l. 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 productsought to be registered; 3. Alteration,mutilation,destruction, obliteration, or removal of any part of a label‘ W 4. A medicaldevicethat 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.
Sec. XI. MOTIONFOR RECONSIDERATION/APPEAL · MOTIONFOR RECONSIDERATION/APPEAL
MOTIONFOR RECONSIDERATION/APPEAL The procedure for the filing of Motion for Reconsideration or Appeal shall be in accordancewith the provisions stipulated in Republic Act 9711 and its Implementing Rules and Regulations.
Sec. XII. CONFIDENTIALITY OF INFORMATION · CONFIDENTIALITY OF INFORMATION
CONFIDENTIALITY OF INFORMATION Any officersand employees of CDRRHR shall not make public or use for their own personalgain any trade secret or proprietary informationwhich they obtain or become familiarwith during the course of their official duties. Any officialwho violatesthis provision shallbe dealt with in accordance with the Code of Conductfor Public Officials.
Sec. XIII. SEPARABILITY CLAUSE · SEPARABILITY CLAUSE
SEPARABILITY CLAUSE If any portion or provision of this Order is declaredinvalid or unenforceable or unconstitutional, the validity or enforceability of the remainingportions or provisions shall not be affected, and this Order shall be construed as if it did not containthe particular invalid or enforceable or unconstitutional portionorprovision.
Sec. XIV
REPEALING CLAUSE FDA Memorandum Circular No. 2014-005, Updated List of Medical Devices required to be registered prior to sale distributionand use, and all other issuances inconsistent with the provision of this Order are herebyrepealed or modified accordingly.
Sec. XV. EFFECTIVITY · EFFECTIVITY
EFFECTIVITY This AO shall take effect fifteen (15) days following the completion of its publication in two (2) newspapers of general circulationand filing of three (3) copies hereof to the University of the Philippines Office of the NationalAdministrative Register (UP ONAR). The implementation of the registration of medicaldevices following the new set of regulatory requirements shall be one (1) year afterthe effectivity of this Administrative Order. The CDRRHR may allow the voluntary submission of applicationsusing the new set of requirements earlier than the indicated implementation of this guidelines. UQUE III, MD, MSc Se retary of Health
ANNEX A
LegalRequirements for Application for the Notificationof Medical Devices under Class A and Registration ofMedical Devices under Classes B, C and D 1. 2. 3. Notarized Application Form (Annex G or H) Payment Copy of Letter of Authorization. For imported medical devices, the copy of the Letter of Authorization shall be accompaniedby an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the authorization is true and correct. A government — issued certificate attesting to the status of the Manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificatefor ISO 13485. For imported medical devices, the copy of the certificateshall be accompanied by an original copy of a notarizeddeclarationfrom the legal manufacturer or product owner attesting that the certificate is true and correct. For imported medical devices, the Certificate of Product Notification, Certificate of Product Registration, or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency or accreditednotified body in the country of origin. The copy of the certificate shallbe accompaniedby an original copy of a notarizeddeclarationfromthe legal manufacturer or product owner attesting that the certificate is true and correct. Colored picture of the devicefrom all sides. However, the CDRRHR can require a representative sample or commercial presentation for verification purposes.
ANNEX B
Technical Requirements for Application for the Notificationof Medical Devices under Class A 1. Device descriptionconsisting of the following: a. Intended use b. Instructionfor use 0. List of all raw materials (1. Technical specification of the finished product e. List of reference codes, sizes,colors, models and variance, whichever is applicable. 2. Certificate of Conformity (issued by government agency dealing with metrology) on the aspect of manufacture relating to metrology for devices with measuring functions, if applicable 3. Declaration of Conformity (self declaration by the manufacturer) with product standards, if applicable 4. Clear and complete colored pictures of label from all sides of the packaging (loose label or artworks of all layers of packaging) 5. Declaration of shelf life
ANNEX C
Technical Requirements for the Initial Registration of Medical Devices under Class B in Accordance withthe CSDT Template 1. Executive Summary. The executive summary shall includethe following information: a. worm? an overview, e. g., introductorydescriptive information on the medical device, the intended uses and indicationsfor use of the medical device, any novel features and a synopsis of the content of the CSDT; the commercial marketinghistory; the intended uses and indications in labeling; the list of regulatoryapprovals or marketing clearances obtained; the status of any pending request formarket clearance; and the importantsafety/performance related information. 2. Relevantessential principles and method/sused to demonstrate conformity, if applicable. (See Annex K) 3. Device description with the following information: r'P‘qo rm 9-9 9‘s» Intended Use Indications of use Instruction for use Contraindications Warnings Precautions Potential adverseeffects Alternative therapy (practices and procedures) Materials. A description of the materials of the deviceand their physical properties to the extent necessary to demonstrate conformity with the relevant Essential Principles. The information shall include complete chemical, biological and physical characterization of the materials of the device. Other Relevant Specifications to include the following: j.l The functional characteristics and technical performance specifications of the device including, as relevant: accuracy, sensitivity, specificity of measuring and diagnostic medical devices, reliability, and other factors j.2 If applicable, other specifications including chemical, physical, electrical,mechanical, biological, software, sterility,stability, storage and transport, and packaging. Other Descriptive Information to demonstrate conformity with the relevant Essential Principles (e. g. biocompatibility category forthe finishedmedical device) 4. Summary of Design Verificationand Validation Documents: The validation documentsshall consist of the following: a. b. Declaration/Certificates of Conformity to the product standards issued by the manufacturer Summaries or reports of tests and evaluationbased on other standards, manufacturermethodsand tests, or alternative ways of demonstratingcompliance, such as a listing of and conclusions NF" drawn from published reports that concern the safety and performance of aspects of the medicaldevice with reference to the Essential Principles; 0. Data summaries or tests reports and evaluations covering the following appropriate test reports, whichever is applicable: c.1 Engineering test Laboratory test c.3 Biocompatibility test c.4 Animal Test Simulated Use 0.6 SoftwareValidation c.7 Pre-clinical studies Clear and complete colored pictures of label in all angles of the packaging(loose label or artworks of all layers of packaging) Risk Analysis to includethe results Physical Manufacturerinformation a. Manufacturing process, including quality assurance measures. This shouldincludethe manufacturing methodsand procedures, manufacturing environment or conditions, facilitiesand controls. The information may be presented in the form of a process flow chart showing an overview of production, controls, assembly, final product testing, and packaging of finished medicaldevice. b. A brief summary of the sterilization methodshouldbe included.
ANNEX D
Technical Requirements for the Initial Registration of Medical Devices under Class C in Accordance with the CSDT Template 1. Executive Summary. The executive summary shall include the following information: a. “urea-99‘ an overview, e. g., introductory descriptive information on the medical device, the intended uses and indicationsfor use of the medical device, any novel features and a synopsis of the content of the CSDT; the commercial marketinghistory; the intended uses and indications in labeling; the list of regulatoryapprovals or marketing clearances obtained; the status of any pending request for market clearance; and the importantsafety/performance related information. Relevant essential principles and method/s used to demonstrate conformity, if applicable. (See Annex K) 3. Device description with the following information: #qu rho 999‘s» Intended use Indications of use Instructionfor use Contraindications Warnings Precautions Potentialadverseeffects Alternative therapy (practices and procedures) Materials. A description of the materials of the deviceand their physical properties to the extent necessary to demonstrate conformity with the relevant Essential Principles. Theinformation shall include complete chemical, biological and physical characterization of the materials of the device. Other Relevant Specifications to include the following: j.1 The functionalcharacteristics and technical performance specifications of the device including, as relevant: accuracy, sensitivity, specificity of measuring and diagnostic medical devices, reliability, and other factors j.2 If applicable, other specifications including chemical, physical, electrical, mechanical, biological, software, sterility, stability, storage and transport, and packaging. Other Descriptive Information to demonstrate conformity with the relevantEssential Principles (e. g. biocompatibility category forthe finishedmedical device) 4. Summary of Design Verificationand Validation Documents: The validationdocumentsshall consist of the following: a. Declaration/Certificates of Conformity to the product standards issued by the manufacturer b. Summaries or reports of tests and evaluation based on other standards, manufacturermethods and tests, or alternative ways of demonstratingcompliance, such as a listing of and conclusions >19 C. drawn from published reports that concern the safety and performance of aspects of the medicaldevicewith reference to the Essential Principles; ‘ data summaries or tests reports and evaluations covering the following appropriate test reports, whichever is applicable: c.l Engineering test c.2 Laboratory test c.3 Biocompatibility test c.4 Animal Test Simulated Use d. Clinical evidence for the following: d.1 Implantable devices d.2 Newly introduceddevices d.3 Devices incorporating new materials coming into contact with the patient. d.4 Existing materials applied in a body part not previously exposed to that material, and for which no prior chemical experience exists. d.5 An existing devicethat is modified and the modification might affect safety and effectiveness. 6. Softwarevalidation studies, if applicable. f. Biological evaluation, if applicable. Clear and complete colored pictures of label from all sides of the packaging(loose label or artworks of all layers of packaging) Risk assessment consisting of risk analysis, evaluationandreduction measures. Physical Manufacturer information a. Manufacturing process, including quality assurancemeasures. This shouldincludethe manufacturing methodsand procedures, manufacturing environment or conditions, facilities and controls. The information may be presented in the form of a process flow chart showing an overview of production,controls, assembly, final producttesting, and packaging of finished medicaldevice. A brief summary of the sterilization methodshould be included.
ANNEX E
Technical Requirements for the Initial Registration of Medical Devices under Class D in Accordance with the CSDT 1. Executive Summary. The executive summary shall includethe following information: a. an overview, e. g., introductorydescriptive information on the medical device, the intended uses and indications for use of the medical device, any novel features and a synopsis of the content of the CSDT; b. the commercial marketinghistory; 0. the intended uses and indications in labeling; d. the list of regulatoryapprovals or marketing clearances obtained; e. the status of any pending request formarket clearance; and f. the important safety/performance relatedinformation. 2. Relevantessential principles and method/s used to demonstrate conformity, if applicable. (See Annex K) 3. Device description with the following information: Intended use . Indications of use Instructionfor use . Contraindications Warnings Precautions . Potentialadverseeffects . Alternative therapy(practices and procedures) Materials. A description of the materials of the deviceandtheir physical properties to the extent necessary to demonstrate conformity with the relevantEssential Principles. The information shall include complete chemical, biological and physical characterization of the materials of the device. . j. Other Relevant Specifications to include the following: j.1 The functional characteristics and technical performance specifications of the device including, as relevant: accuracy, sensitivity, specificity of measuring and diagnostic medical devices, reliability, and other factors j.2 If applicable, other specificationsincluding chemical, physical, electrical, mechanical, biological, software, sterility,stability, storage and transport, and packaging. k. Other Descriptive Information to demonstrate conformity with the relevant Essential Principles (6. g. biocompatibility category for the finishedmedical device) 4. Summary of Design Verificationand Validation Documents: The validationdocumentsshall consist of the following: a. Declaration/Certificates of Conformity to the product standardsissued by the manufacturer b. Summaries or reports of tests and evaluationbased on other standards, manufacturermethods and tests, or alternative ways of demonstrating compliance, such as a listing of and conclusionsdrawn from published rumor-raga :19 0‘9: (1°ng reports that concern the safety and performance of aspects of the medicaldevice with reference to the Essential Principles; Data summaries or tests reports andevaluations covering the following appropriate test reports, Whichever is applicable: c.1 Engineering test c.2 Laboratory test c.3 Biocompatibility test c.4 Animal Test c.5 Simulated Use Clinicalevidence Softwarevalidation studies, if applicable. Biological evaluation, if applicable. A bibliography of all published reports dealing with the use, safety, and effectiveness of the device. 5. Clear and complete colored pictures of label from all sides of the packaging (loose label or artworks of all layers of packaging) 6. Risk assessment consisting of risk analysis, evaluation and reduction measures. 7. Physical Manufacturer information a. Manufacturing process, includingquality assurance measures. This shouldincludethe manufacturing methodsand procedures, manufacturing environment or conditions, facilitiesand controls.The information may be presented in the form of a process flow chart showing an overview of production, controls, assembly, final product testing, and packaging of finished medicaldevice. A brief summary of the sterilizationmethod shouldbe included.
ANNEX F
Requirements for the Renewal of Notification/Registration of Medical Devices for All Classifications Notarized Application Form (Annex H or 1) Payment Copy of Letter of Authorization. For imported medical devices, the copy of the Letter of Authorizationshall be accompaniedby an original copy of a notarized declarationfrom the legal manufacturer or product owner attesting that the authorization is true and correct. 4. A government — issued certificate attesting to the status of the Manufacturerwith regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificatefor ISO 13485. For imported medical devices, the copy of the certificateshall be accompaniedby an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct. 5. Colored picture of the devicefrom all sides. However, the CDRRHR can require a representativesample or commercial presentation for verification purposes. 6. Clear and complete colored pictures of commerciallabel from all sides of the packaging. UJNH
ANNEX G
Requirements for Application for the Certificateof Medical Device Listing 1. Notarized Application Form (Annex J) 2. Notarizedletter addressed to the Director, Center for Device Regulation, Radiation Health, and Research, stating that the medicaldevicewill be used solely for research, analysis, or is being donated by a certain organization and is not intended for sale. The letter should contain the following information: a. Complete list of the devices indicating the quantity, brand andthe name of the manufacturer of the product b. Declarationthat the organization shall be the sole entity responsible for the medicaldevices and that the CDRRHR—FDA, DOH will not be held liable for any safety issue concerning the product. Certificate of ProductNotification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the deviceissued by the regulatory agency in the country where the device will come from. For a donatedmedical device (brandnew), a certified true copy of the deed of donation, the deed of acceptance, and the packing list or any document that will show the quantity of the product. 5. Copy of SEC or DTI registration, when applicable
ANNEX H
APPLICATION FORMFOR MEDICAL DEVICENOTIFICATION (www.fda.gov.ph) TO THE DIRECTOR GENERAL Food and Drug Administration Department of Health ATTN:The Director Centerfor Device Regulation, Radiation Health, and Research Sir/Madam: In accordancewith RA. 971 and other related issuance/s, we wish to apply forthe ( ) initial ( ) renewal notificationof our product. APPLICATIONFORMEDICAL DEVICE NOTIFICATION Device Name: Device Proprietary/Brand Name Model/Reference Number/Property Code/ItemCode: Intended Use of Device: Applicant’s Company Name: Address: LTO No. Validity: Tel No.Fax. No.E-mailaddress: Company President/General Manager: Regulatory Officer: Legal Manufacturer(Product Owner): Address: Manufacturing site: We hereby certify that the foregoing informationand all other data submittedin connectionwith this application are true and correct. We understandthat the failure to report all required information or submission of false or misleading information is an offense punishableby law. We certify that we have examinedthe following statements and we attest to their accuracy: 1. The Current Good Manufacturing Practice/ QualityManagement System (ISO) is applied in full in the manufacture of this product. The manufacturing procedure is exactly as specified in the submitted manufacturing process. 3. The finished product is tested and certified to be fully compliant with the specifications in the accompanying documentation. N 4. The person releasing the product for sale is an authorizedand/or qualified person. 5. The procedures for control of the finished product have been validated. 6. The applicant has a standard operatingprocedure for handling any adverse event related to the use of the device. 7. The applicant has a standard operating procedure for handlingproduct recalls. 8. All the documentation referred to inthis application is availablefor review during comprehensive inspection of the establishment. 9. We shall change the brand name so submitted shouldthe proper authority decides with finality that we have no right to appropriate and utilize the saidbrand name; and 10. We shall acknowledge and agree to indemnify and/orhold FDA freeand harmless against any and all third party claims arising from the acceptance of suchbrand name of the product for registration with FDA. 1. The product covered by this declarationwill not undergo any change inthe ownership, registrant’s address/location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing process (if applicable), labeling or commercial presentation, and packaging of the product covered by this certificate of notification without prior approval of this office. 12. We acknowledge and agree that inthe event that there is an unauthorized change inthe ownership, its address/ location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing process (if applicable), labeling or commercial presentation, and packaging of the product: i. The CDRRHR may automaticallysuspend the LTO and/0r CMDN of the product; ii. We will voluntarily recall the product fi'om the market; and iii. We will indemnify and/or hold CDRRHR free and harmless against any and all third party claims and/or actions pertaining to the above unauthorized change(s). Regulatory Officer: Owner/General Manager: SIGNATURE OVERPRINTEDNAME SIGNATUREOVER PRINTEDNAME Governmentissued ID Number:Governmentissued ID Number: Date Issued: Date Issued: Place of Issuance: Place of Issuance: SUBSCRIBEDAND SWORN before me this day of affiant exhibiting to me his/her Government issued ID Numberindicatedabove. NOTARYPUBLIC Doc. No. Page No. Book No. Series of
ANNEX I
APPLICATIONFORMFOR MEDICALDEVICE REGISTRATION (www.fda.gov.ph) TO THE DIRECTOR GENERAL Food and Drug Administration Department of Health ATTN: The Director Centerfor Device Regulation, Radiation Health, and Research Sir/Madam: Inaccordance with RA. 971 l andotherrelated issuance/s, we wish to apply forthe ( ) initial ( ) renewal registration of our product. APPLICATIONFORMEDICALDEVICE REGISTRATION Device Name: Device Proprietary/Brand Name: Model/Reference Number/Property Code/ItemCode: Classification: Class B Class C Class D Intended Use of Device: Applicant’s Company Name: Address: LTO No. Validity: Tel No. Fax. No. E-mail address: Company Owner/General Manager: Regulatory Officer: Legal Manufacturer(Product Owner): Address: Manufacturing site: We hereby certify that the foregoing information and all other data submitted in connectionwith this application are true and correct. We understandthat the failure to report all required information or submission of false or misleading information is an offense punishableby law. We certify that we have examinedthe following statements and we attest to their accuracy: 1. The Current Good Manufacturing Practice/ Quality ManagementSystem (ISO) is applied in full in the manufacture of this product. 2. The manufacturing procedure is exactly as specified in the submitted manufacturing process. 3. The finished product is tested and certified to be fully compliant with the specifications in the accompanying documentation. 4. The person releasing the product for sale is an authorizedand/or qualified person. The procedures for control of the finished product have been validated. 6. The applicant has a standard operating procedure for handling any adverse event related to the use of the device. . The applicant has a standard operating procedure for handling product recalls. All the documentationreferred to in this application is availablefor review duringcomprehensive inspection of the establishment. 9. We shall change the brand name so submitted shouldthe proper authority decide with finality that we have no right to appropriate and utilize the said brand name; and 10. We shall acknowledge and agree to indemnify and/or hold FDA freeandharmless against any and allthird party claims arising fromthe acceptance of suchbrand name of the product for registration with FDA. 1. The product covered by this declarationwill not undergo any change inthe ownership,registrant’s address/location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing process (if applicable),labeling or commercial presentation, and packaging of the product covered by this certificate of notificationwithout prior approval of this office. 12. We acknowledge and agree that in the event thatthere is an unauthorized change inthe ownership, its address/location, manufacturer, ingredients, formulation, size, reference number, use, manufacturing process (if applicable),labeling or commercial presentation, and packaging of the product: i. The CDRRHR may automatically suspend the LTO and/or CMDR of the product ii. We will voluntarily recall the product from the market; and iii. We will indemnify and/or hold CDRRI-IR free and harmless against any and all third party claims and/or actions pertaining to the above unauthorized change(s). E" .ooq Regulatory Officer: Owner/General Manager: SIGNATURE OVER PRINTEDNAME SIGNATUREOVER PRINTED NAME Governmentissued ID Number: Governmentissued ID Number: Date Issued: Date Issued: Place of Issuance: Place of Issuance: SUBSCRIBED AND SWORNbefore me this day of affiant exhibiting to me his/her government issued ID Numberindicatedabove. NOTARYPUBLIC Doc. No. Page No. Book No. Series of
ANNEX J
APPLICATION FORM FOR MEDICAL DEVICE LISTING (www.fda.gov.ph) TO THE DIRECTOR GENERAL Food and Drug Administration Department of Health ATTN: The Director Center for Device Regulation, Radiation Health, and Research Sir/Madam: In Accordance with RA. 9711 and other related issuances, we Wish to apply for the listing of our product. APPLICATIONFOR MEDICALDEVICELISTING Device Name: Device Proprietary/Brand Name: Model/Reference Number/Property Code/Item Code: Classification: Class A Class B Class C Class D Intended Use of Device: Applicant’s Company Name: Address: Tel No. Fax. No.E-mailaddress: Company Owner/General Manager: Regulatory Officer/Company Representative: Legal Manufacturer(Product Owner): Address: Manufacturing site: We hereby certify that the foregoing informationand all other data submittedin connection with this application are true and correct. We understandthat the failure to report all required information or submission of false or misleading information is an offense punishableby law. Regulatory Officer: SIGNATURE OVERPRINTEDNAME Governmentissued ID Number: Date Issued: Place of Issuance: SUBSCRIBEDAND SWORNbefore me this me his/her government issued ID indicatedabove. Owner/General Manager: SIGNATURE OVER PRINTEDNAME Government issued ID Number: Date Issued: Place of Issuance: day of affiant exhibiting to NOTARYPUBLIC
ANNEX K
EXAMPLEOF AN CHECKLIST ESSENTIALPRINCIPLESCONFORMITY Essential Principle Applicable to the device? Method of Conformity Identity of Specific Documents 1. Medical devicesshouldbe designed andmanufactured in such a way that, when used under the conditionsand for the purposes intended and, where applicable,by virtue ofthe technical knowledge,experience, education or training of intended users, they will not compromise the clinicalcondition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. Yes 2. The solutions adopted by the manufacturerfor the design and construction ofthe dew'ces shouldconform to safety principles,taking account of the generallyacknowledged state of the art. In selecting the most appropriate solutions, the manufacturershould apply the following principles in the following order: Identify hazards and the associatedrisks arising from the intended use and foreseeable misuse; Eliminate or reducerisks as far as possible(inherently safe design and construction); Where appropriate take adequateprotectionmeasures including alarms if necessary, in relation to risks that cannot be eliminated, Inform users of the residualrisks due to any shortcomings of the protection measures adopted. Yes 3. Devices should achievethe performance intended by the manufacturer and be designed, manufacturedand packaged in such a way that they are suitablefor one ormore of the functions within the scope of the definition of a medical device applicable in each jurisdiction. Yes 4. The characteristicsand performances referred to in Clauses l, and _ should not be adversely affected to such a degree that the clinical conditionsand safety of the patients and, where applicable, of other persons are compromisedduring the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditionsof use and has been properly maintained in accordance with the manufacturer’sinstructions. Yes 5. The devices shouldbe designed, manufacturedand packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information providedby the manufacturer. Yes 7.1 The devices shouldbe designed and manufacturedin such a way as to ensure the characteristics and performance referred to in Section I of the “General Requirements”. Particularattentionshouldbe paid to: o The choice of materials used, particularly as regards toxicity and, where appropriate, flammability, The compatibility betweenthe materialsused and biological tissues, cells and body fluids, taking into account the intended purpose of the device. The choice of materialsused which should reflect, where appropriate, matters such as hardness, wear and fatigue strength. 7.2 The devicesshouldbe designed, manufactured and packed insuch a way as to minimizethe risk posed by contaminants and residues to the persons involved in the transport,storage and use of the devicesand to the patients, taking account of the intended purpose of the product. Particularattention shouldbe paid to the tissues exposed and to the durationand frequency of exposure