Provisional Authorization Process Implemented by HSA to Expedite Approval of COVID-19 Diagnostic Tests


An urgent need for timely detection of COVID-19 infections has primed  Singapore’s  Health Science Authority (HSA) to ensuring the rapid availability of good quality COVID-19 diagnostic tests. Since January 29, 2020, the HSA has addressed this need by providing regulatory and scientific advice to research institutions as well as local and multi-national companies.

Provisional Authorization:

The provisional authorization process for kits intended to detect and/or diagnosis COVID-19 infection was implemented to address the need for COVID-19 diagnostic tests. It is based on a risk-calibrated review process that considers the design aspects of the test (e.g. primers and probe design, target sequence in viral RNA) and the supporting validation data (e.g. limit of detection, cross reactivity, inclusivity). This implementation is an interim measure and any application that would like to supply these tests long term will need to be registered with the HSA.

content of the Provisional Authorization Application: 

An application can be submitted to the HSA via email with the subject “Provisional Authorization” and the following information:

  • Brief description of test (test design, target biomarker, device technology, description of key functional elements, specifications, composition, accessories)
  • Intended purpose
  • Information for Users (IFU)
  • Summary of analytical validation (e.g. limit of detection, inclusivity, cross-reactivity, precision, interfering substances, Hook effect) and clinical data
  • Summary of any planned or ongoing validation, including clinical studies. Key validation requirements include:
    • Nucleic acid tests
    • Serology tests

Regulatory Summary:

Once the information has been sent the HSA will get in touch with the applicant after 3 working days. If an applicant wishes to supply the diagnostic test test past the interim of the COVID-19 pandemic it must be formally registered with a complete technical file to the HSA.  

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations..  To learn more, please contact us at

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