in vitro diagnostic draft regulation fda philippines

FDA Philippines issues draft regulation on IVD market authorizations

The Food and Drug Administration (FDA) of the Philippines has issued a draft regulation on IVD market authorizations. The draft is open for comments from industry stakeholders until 7 February 2022.

Here are the main points of the draft regulation issued by the FDA:

 

  1. New registration, notification and listing certificates specially for In-Vitro Diagnostics will be issued:
  • Certificate of In-vitro Diagnostic Notification or CIVDN
  • Certificate of In-vitro Diagnostic Registration or CIVDR
  • Certificate of In-Vitro Diagnostic Listing or CIVDL.

 Please note that the regulation will be introduced in phases. During the first phase, the FDA will issue:  

  • CIVDN for all Class A IVDS
  • CIVDN for Class B, C and D IVDs that are NOT on the list of registrable IVDs. This list is maintained by the FDA. This CIVDN will only be valid for 2 years at which point the Marketing Authorization Holder (MAH) must apply for a CIVDR.
  • CIVDR for all registrable devices (as listed by the FDA)
  • CIVDL (see point 7 below).

During the second phase, the FDA will no longer issue CIVDN for Class B, C and D and the registration and issuance of CIVDR will be mandatory for all Class B, C and D IVDs.

  1. A valid License To Operate (LTO) as a Medical Device Importer/Distributor/ Manufacturer/Trader (whichever is applicable) is required by any establishment that intends to place IVDs on the market in the Philippines. The LTO is required prior to applying for CIVDN and/or CIVDR. Donors, organizations, or persons involved in donations, medical missions and other humanitarian activities are exempted from LTO requirements.
  2. Only those product applications which comply with the Philippines’ FDA legal and technical requirements, as well as any performance evaluation requirements from the National Reference Laboratory (NRL), will be approved for CIVDR.
  3. The following items are not classified as IVD: 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.
  4. Applications for the registration of classes B, C and D IVDs shall require endorsement from either the FDA Common Services Laboratory, the NRL or other FDA accredited/recognized laboratory in the form of performance evaluation testing. This is subject to additional costs. Guidelines on this endorsement, responsibilities of the applicant and of the testing laboratories shall be covered by a separate FDA Circular. Please note that performance evaluation testing is a requirement regardless of whether any deficiencies were found during the document and technical review. If any such deficiencies are found then the applicant will be requested to submit supplementary evidence to support the application.
  5. IVDs that have passed the World Health Organization (WHO) pre-qualification shall not undergo performance evaluation but will undergo document review by the FDA. However, the IVD must conform to the standard criteria on parameters set by the NRL.
  6. IVDs that are 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 must apply for a Certificate of IVD Listing (CIVDL).
  7. The proposed validity of CIVDN and CIVDR is as follows:

  CIVDR:

  • The CIVDR validity period is 5 years. The CIVDR must be renewed every 5 years after initial approval.
  • A fast-tracked or “automatic renewal” is possible for certain CIVDR as long as there is no change in the composition, packaging, intended use, process and components of the IVD in addition to fulfilling certain application procedures.
  • The validity of the CIVDR is independent of the validity of the performance evaluation set by the concerned NRL.

 CIVDN:

  • The validity of CIVDN for Class A products is 5 years. The CIVDN must be renewed every 5 years after initial approval.
  • A fast-tracked or “automatic renewal” is possible for certain CIVDN Class A products, as long as there is no change in the composition, packaging, intended use, process and components of the IVD in addition to fulfilling certain application procedures.
  • The validity of CIVDN for Class B, C and D products issued under phase 1 is limited to 2 years after which the MAH shall apply for CIVDR.
  1. Certain IVDs do not qualify for fast-track or “automatic renewal” as they are subject to Post Approval Commitments to ensure their quality, safety and performance. Post Approval Commitments are indicated in the issued CIVDR or CIVDN. These PAC must be submitted to FDA during application for renewal of CIVDR or CIVDN in addition to the regular requirements specified in Annex E.
  2. The FDA shall issue a regularly updated list of IVDs that need to undergo performance testing by the National Reference Laboratory prior to registration.

More information:

The full draft of this regulation and its annexes can be accessed at https://www.fda.gov.ph/draft-for-comments-rules-and-regulations-governing-the-issuance-of-an-authorization-for-an-in-vitro-diagnostic-medical-device-ivd/.

If you wish to comment or understand more about this draft regulation, please contact your designated Regulatory Affairs Specialist at Andaman Medical. You may also submit your comments directly to cdrrhr-prsdd@fda.gov.ph. The deadline for submission of comments is 7 February 2022.

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