philippines fda guidelines distribution and use of covid19 self test kits

Philippines DOH issues guidelines on distribution and use of Covid-19 Antigen Self-Test Kits

The Philippines Department of Health (DOH) has released guidelines on the appropriate procurement, distribution and use of antigen self-test kit on 26 January 2022. The guidelines include instructions to manufacturers, suppliers and distributors on ensuring that the instructions for use are user-friendly including a requirement to create a step-by-step video guide and provide translations.

All public and private DOH licensed health facilities, Centers for Health Development (CHDs), other government agencies and private entities may procure, distribute, or dispense Philippines FDA approved antigen self-test kits without the need for a valid prescription for the diagnosis of COVID-19.

The following is the summary of the guidelines:

Selection and Procurement


    1. Only antigen self-test kits approved by the Philippines FDA and validated by the Research Institute for Tropical Medicine (RITM) may be used. The list of FDA-approved test kits shall be made available through this site: FDA Approved TestKits.
    2. Procurement using DOH funds or using Philippines Health Insurance Corporation in their benefits package shall be within the bounds of Health Technology Assessment Council recommendations.

Guidelines For Suppliers, Manufacturers, and Healthcare Providers


a) Manufacturers, suppliers, and distributors shall develop references for appropriate use for the general public that shall include:

    1. Instructions for Use (IFU) – readable, user-friendly and simplified to provide guidance to the lay public on the test kit’s proper administration, interpretation of results and disposal
    2. A step-by-step video guide specific to the antigen kit for easy reference of the public, and references and links submitted to the DOH for public posting
    3. Filipino-language translation of the reference materials in plain language format, and preferably with other additional regional dialect translations if available

b) Manufacturers, suppliers, and distributors shall submit reports of suspected counterfeit, uncertified, and substandard test kits to the FDA.

c) National Government Agencies, Local Government Units, Health Care Provider Network (HCPNSs), and health facilities which are concerned with such tests shall offer facility- or online-based orientation and references in the form of demonstration, instructional videos, leaflets, and other formats which shall highlight:

  • Differences between self-administered and healthcare worker-administered test kits
  • Instructions for use, interpretation and reporting of results
  • Disposal of the used kits
  • Contact list or hotlines for those that will require further assistance in conducting the test, or linkage with a laboratory for confirmatory testing, and in reporting their test results. 

Appropriate Use and Interpretation of Results


  • RT-PCR is still the preferred diagnostic method for COVID-19
  • Self-administered antigen testing shall be recommended only for symptomatic individuals within 7 days from onset of symptoms, especially if capacity for timely RT-PCR results is limited or not available.
  • Self-administered antigen test kits shall NOT be recommended for (1) asymptomatic close contacts and (2) screening of asymptomatic individuals.
  • A positive antigen test among symptomatic individuals and suspect or probable COVID-19 cases and their close contacts shall be interpreted and managed as a confirmed COVID-19 case.

For more information


Please refer to the link:

Learn about the Performance Requirements for Covid-19 Test Kits in the Philippines.

Learn about the Process for Covid-19 Test Kit Applications.  

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