Draft for Comments || Rules and Regulations Governing the Issuance of an Authorization for an In-Vitro Diagnostic Medical Device (IVD)

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All comments can be sent at [email protected]. Deadline of submission of comments shall be by 07 February 2022.

I. RATIONALE / BACKGROUND

Republic Act No. 9711 and its Implementing Rules and Regulations, declare that it is the policy of the state to insure the safety, efficacy and quality of health products including IVDs in the country so as to protect the health of the Filipino people.

The signing of the AMDD in 2014, mandated the Philippines to implement the following provisions to  a) require the person responsible for placing the IVD in that Member State or the authorized representative to register the IVD with the regulatory authority of that Member State, b) undertake all necessary measures to ensure that only IVD which conform to the AMDD may be placed on markets of that Member State and c) put in place an appropriate system for the registration of IVD with the Regulatory Authority of that Member State.

The Department of Health through the Food and Drug Administration (FDA) – Center for Device Regulation, Radiation Health and Research (CDRRHR) hereby adopts, issues and implement the AMDD guidelines on the issuance of an authorization for IVD and to provide the regulatory requirements and authorization process.

II. OBJECTIVE

This Administrative Order aims to specify the rules, guidelines, procedures and requirements of the FDA-CDRRHR relative to the issuance of an authorization for IVD.

III. SCOPE

This Administrative Order shall cover all IVDs and apply to all manufacturers, traders and distributors (e.g. importers, exporters and wholesalers) of IVD in the Philippines.

IV. DEFINITION OF TERMS

  1. Applicant – refers to any individual, partnership, corporation, association, and/or organization either a manufacturer, trader, distributor, importer, exporter applying for an authorization.
  2. ASEAN Medical Device Directive (AMDD) – refers to the agreement of ASEAN Member States harmonizing the regulation of medical device.
  3. Authorization – means a permission embodied in a document granted by the FDA to a natural or juridical person who has submitted an application to implement the manufacture, importation, exportation, sale, offer for sale, distribution transfer, and/or where appropriate, the use, testing, promotion, advertising, or sponsorship of health products. The authorization can take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption or any similar document.
  4. Calibrator – refer to any substance, material or article intended by its product owner to be used in the calibration of a measuring instrument or measuring system.
  5. Certificate of IVD Listing (CIVDL) – refers to the authorization issued to all IVD intended for clinical evidence study, clinical research, educational purposes, samples for performance evaluation, donation, exhibit, personal use and that is not intended for sale.
  6. Certificate of IVD Notification (CIVDN) – refers to the authorization issued to all class A IVD that complies with all the requirements for notification.
  7. Certificate of IVD Registration (CIVDR) – refers to the authorization issued to all class B, C and D IVD that complies with all the requirements for registration.
  8. Distributor/importer/exporter – means any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets.
  9. Distributor/wholesaler – means any establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on a wholesale basis.
  10. Establishments – means a sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of IVD including the facilities and installation needed for its activities.
  11. Instruction for use – refers to the all necessary information from the product owner including the procedures, methods, frequency, duration, quantity and preparation to be followed for sale use of the IVD, instructions needed to use the IVD in a safe manner shall, to the extent possible, be included on the IVD itself and/or its packaging by other formats/forms. This is the detailed instruction for use for the users of the medical device.  The instruction should be clear enough to guide its users.
  12. Instrument – refers to any equipment or apparatus intended by the product owner to be used as IVD.
  13. Intended use – this refers to the use for which the IVD is intended, for which it is suited according to the data supplied by the product owner in the instructions as well as the functional capability of the IVD.
  14. In-Vitro Diagnostic Medical Device (IVD) – refers to any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donation, derived from the human body, solely or principally for the purpose of providing information:a. concerning a physiological or pathological state;
    b. concerning a congenital abnormality;
    c. tissue donations, with potential recipients; or to determine the safety and compatibility of donations, including blood and
    d. to monitor therapeutic measures,and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its product owner to be used for in vitro diagnostic examination.
  15. Label – a written, printed or graphic information provided upon the IVD itself. It includes information provided on the packaging of each unit or on the packaging of multiple medical devices.
  16. Labelling – the label, instructions for use, and/or any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents.
  17. 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 IVD.
  18. Listing – refers to the process of informing the FDA that such IVD are being manufactured and imported solely for clinical evidence study, clinical research, educational purposes, samples for performance evaluation, donation, exhibit, personal use and that is not intended for sale.
  19. Manufacturer – means an establishment engaged in any and all operations involved in the production of IVD including preparation, processing, compounding, formulating, filling, packing, re-packing, altering, ornamenting, finishing, and labeling with the end view of its storage, sale or distribution.
  20. Marketing Authorization Holder (MAH) – refers to the medical device company, corporate or legal entity in whose name the CIVDR or CIVDN for an IVD has been granted. The MAH is responsible for all aspects of the product, including quality and compliance with the conditions of the issued CIVDR or CIVDN. The MAH may be a manufacturer, trader, or distributor (exporter, importer or wholesaler) of IVDs.
  21. National Reference Laboratory (NRL) – refers to agency/laboratories in the Philippines mandated to conduct performance evaluation of the IVD. Please see Annex G – List of host hospitals and testing laboratories with their designated National Reference Laboratories based on technical expertise. The NRLs and their corresponding technical capabilities may be added which will be indicated in a separate Department Order.
  22. Notification – means the process of approval of an application to notify class A IVDs 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 class A IVDs.
  23. Performance evaluation – refers to the tests being done by the appropriate NRL to IVD to verify compliance to the test criteria set by the NRL or the data submitted by the applicant for the purpose of FDA registration.
  24. Person – refers to any individual, partnership, corporation, association and/or organization.
  25. Product owner – refers to any person who:a. supplies the IVD under his own name, or under any trade mark, design, trade name or other name or mark owned or controlled by him; and
    b. is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the IVD, or for assigning to it a purpose, whether those tasks are performed by him or on his behalf.
  26. Product standard – refers to in-vitro standard set, formulated, and or/established by the following:a. Department of Trade and Industry – Bureau of Philippine Standards (Philippine National Standard)
    b. International Standardization Organization (ISO)
    c. International Electrochemical Commission (IEC)
    d. Other International Standard Body or any person standards which may be accepted by FDA for the purpose of authorization.
  27. Reagent – refers to any chemical, biological or immunological components, solutions or preparations intended by the product owner to be used as IVD.
  28. Registration – means the process of approval of an application to register class B, C and D IVD 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 class B, C, and D IVD.
  29. Safety – means that the product will not impose any danger, injury, damage or undesirable effect to a person.
  30. Self-testing – testing/monitoring performed by lay persons.
  31. Trader – means any establishment which is registered owner of a health product and procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.
  32. Warning – refers to the specific hazard alert information that a user needs to know before using the IVD.

V. POLICIES AND GUIDELINES

A. General Guidelines

  1. All establishments that intend to place IVDs in the Philippine market are required to secure an LTO as Medical Device Importer/ Distributor/ Manufacturer/ Trader (whichever is applicable) prior to securing a CIVDN and/or CIVDR. Donors, organizations or person involved in donations, medical missions and other humanitarian activities are exempted from LTO requirements.
  2. The establishment shall apply for CIVDN or CIVDR based on the following classification of IVD. The establishment shall apply for CIVDN for Class A IVD and/or CIVDR for Class B, C or D IVD.
         Class                                      Level
    A Low Individual Risk and Low Public Health Risk
    B Moderate Individual Risk and/or Low Public Health Risk
    C High Individual Risk and/or Moderate Public Health Risk
     D  High Individual Risk and High Public Health Risk
  3. Approval of application for CIVDR shall be based on compliance with the FDA legal and technical requirements and results of performance evaluation for those IVDs that require performance evaluation by NRLs.
  4. The certificate of IVD notification or registration shall be issued by the FDA through the CDRRHR if the application is found to be meritorious; otherwise, the application shall be considered disapproved.
  5. The Notification Number or Registration Number shall be issued to the IVD with approved CIVDN or CIVDR.
  6. Reagents, reagent product, calibrator, control material, kit, instruments, apparatus, equipment or systems or software manufactured, sold or represented by manufacturers not for use in in-vitro diagnostic application and general laboratory use purposes are not classified as IVD.
  7. The applicant shall classify the IVD based on the risk classification rules for IVD medical devices in Annex 3 of the AMDD. The CDRRHR shall verify the classification made by the applicant and shall reclassify the device as deemed appropriate or when the level of risk is changed by a certain incident in the manufacture, distribution or use of the IVD upon proper consultation with the advisory committee set forth by the Philippine FDA and/or the ASEAN.
  8. IVD strictly for research, clinical trial, exhibit and/or donated brand new IVD equipment except for the reagents are exempted from notification and registration. However, the researcher, institution and/or user of such devices shall apply for a CIVDL. All applicants seeking for CIVDL shall submit the necessary documentary requirements specified in Annex F.
  9. Application for registration of IVD for class B, C and D shall be endorsed to the FDA Common Services Laboratory, NRL or other FDA accredited/recognized laboratory for performance evaluation, regardless if deficiencies were found during the document and technical review. Guidelines on the endorsement of application, responsibilities of the applicant and of the NRL regarding the performance evaluation of IVDs shall be covered by a separate FDA Circular.
  10. Validity of CIVDR
    a. The validity of CIVDN shall be as specified in Section VII (1) of this Order.
    b. The CIVDR shall be valid for five (5) years and shall be renewed every five (5) years after initial approval.
    c. The CIVDN or CIVDR shall remain valid as long as there is no change in the composition, packaging, intended use, process and components of the IVD.
    d. The validity of the CIVDR is independent of the validity of the performance evaluation set by the concerned NRL.
  11. All IVDs shall follow the existing labelling requirements of the FDA on medical devices.
  12. This Order shall be reviewed by the FDA within five (5) years of implementation.

B. Specific Guidelines

  1. The applicant shall follow the latest FDA policy/guidelines on the submission of application.
  2. Receiving, processing and evaluation of application for initial and renewal of CIVDN/CIVDR shall be covered by a separate FDA Circular.
  3. All applicants shall submit the following requirements specified in the following Annexes:
    a. Annex A – Legal Requirements for Application for the Notification of IVD under Class A and Registration of IVD under Class B, C and D
    b. Annex B – Technical Requirements for Application for the Notification of IVD under Class A
    c. Annex C – Technical Requirements for the Initial Registration of Class B, C, and D IVD
    The summary list of requirements for the initial registration of Class B, C and D IVD can be found in Annex D.
    d. Annex E – Requirements for the Renewal of Notification/Registration of IVD for All Classifications
    e. Annex F – Requirements for Application for the Certificate of IVD Listing
  4. An application shall be filed separately per specific IVD whether for CIVDN or CIVDR. The CDRRHR reserves the right to ask for additional documents not indicated in this Order that may arise based on the submitted compliance    documents. All documents shall be submitted in English language. Documents    submitted in any other foreign language not accompanied with English translation shall be disapproved.
  5. IVDs that passed the World Health Organization (WHO) pre-qualification shall not undergo performance evaluation but will undergo document review by the FDA. However, the IVD shall conform to the standard criteria on parameters set by the NRL.
  6. Renewal of CIVDR/CIVDN
    a. There shall be automatic renewal of CMDR or CMDN when the following conditions are satisfied:
    i. The application is filed before the expiration date of registration or notification;
    ii. The prescribed renewal fee is paid upon filing of the application; and
    iii. A sworn statement indicating no change or variation whatsoever in the product is attached to the application
    b. Selected IVDs that require post approval commitments to ensure their quality, safety and performance shall not be qualified for automatic renewal. Post approval commitments are indicated in the issued CIVDR or CIVDN. These PAC shall be submitted to FDA during application for renewal of CIVDR or CIVDN in addition to the regular requirements specified in Annex E.
  7. IVD Listings

The filing of application for IVD Listing shall be made prior to the importation of the IVD by the concerned entity (donor, sponsor, research institution, company, individual, etc.)

VI. FEES AND CHARGES

Payment of initial and renewal application fees and other charges (surcharges, penalties, legal research fund fees etc.) shall be collected as may be allowed subject to the existing rules and regulations of the FDA on fees and charges such as Department of Health Administrative Order No. 50 s. 2001 entitled “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs”,  FDA Circular No. 2011-003 or the “Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended by PD 1856” and/or their subsequent amendments.

Performance evaluation fee is separately collected and paid to NRL.

VII. PHASES OF IMPLEMENTATION

This Administrative Order shall be implemented in phases as specified below:

  1. Phase 1: Registration of IVDs based on the latest FDA list of registrable IVDs, Notification of all Class A IVDs, notification of Class B, C and D IVDs that are not included in the latest FDA list of registrable IVDs, and IVD listing.The legal and technical requirements for the notification of Class B, C and D under this Phase shall be the same as in Annex A and Annex C, respectively, of this Order.The validity of CIVDN for Class A IVDs shall be five (5) years and shall be renewed every five (5) years after initial approval.The CIVDN for Class B, C and D IVDs issued under Phase 1 shall be valid for two (2) years after which the MAH shall apply for registration certificate for these IVDs.
  2. Phase 2: Registration of all Class B, C and D IVDs (Notification of Class B, C and D IVDs shall cease during this phase)

VIII. GROUNDS FOR DISAPPROVAL OF APPLICATION, CANCELLATION, REVOCATION AND/OR NON-RENEWAL OF CIVDN AND CIVDR

In addition to the provisions of R.A. 9711 and its Implementing Rules and Regulations the following are the grounds for disapproval of application, cancellation, revocation and/or non-renewal of CIVDN and CIVDR:

  1. Failure to pass/meet the performance evaluation conducted by NRL for Class B, C and D IVDs;
  2. Non – coordination with the NRL after product endorsement;
  3. The manufacture, sale, offering for sale or transfer of IVD that does not meet all the requirements of safety, quality and efficacy;
  4. Misrepresentation or concealment of significant data or information about the product sought to be registered;
  5. Alteration, mutilation, destruction, obliteration or removal of any part of the IVD and labeling;
  6. IVD that has a biological, chemical or physical property that may cause an unacceptable health risk;
  7. Submission of falsified document(s); and/or
  8. Alteration or falsification of issued CIVDN or CIVDR.

IX. PENALTY CLAUSE

Any violation of this Administrative Order consistent with Republic Act No. 3720 and Republic Act No. 9711 and its implementing rules and regulations shall be a ground for filing appropriate administrative charges and/or imposition of administrative sanctions such as, but not limited to, imposition of fines, suspension, cancellation or revocation of any license, permit or registration issued by FDA.

X. SEPARABILITY CLAUSE

In the event that any provision or portion of this Order is declared unauthorized or rendered invalid by any court of law, those provisions not affected by such declaration shall remain valid and effective.

XI. REPEALING CLAUSE

Section B of FDA Memorandum Circular No. 2014-005 entitled “Updated List of Medical Devices required to be registered prior to sale, distribution and use”, relevant provisions of FDA Memorandum No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19” and FDA Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection”, administrative orders, rules and regulations and administrative issuances or parts thereof inconsistent with the provisions of this Order are hereby repealed or modified accordingly.

XII. TRANSITORY PROVISIONS

Phase 1 shall be implemented six (6) months after the effectivity of this Order. The schedule of implementation of phase 2 shall be issued in a separate FDA Circular.

NRL shall inform and update FDA regarding its capability to conduct performance evaluation of IVD. FDA shall issue updated list of IVDs that need to undergo performance testing/verification of NRLs prior to registration.

XIII. EFFECTIVITY

This Administrative Order shall take effect fifteen (15) days following its publication in one (1) newspaper of general circulation or upon filing of the same to the Office of the National Administrative Register, University of the Philippines.

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