Search

HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation

Updated: May 15

The Health Sciences Authority (HSA) is committed to ensuring the rapid availability of diagnostic tests for COVID-19 in Singapore. Since 29 January 2020, HSA has been closely providing regulatory and scientific advice to research institutions as well as local and multi-national companies to ensure the timely availability of good quality performing test kits that are critical during this period of need.


See Table below for more information on the diagnostic tests that we have approved to date via provisional authorisation.


Provisional authorisation


To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. This has helped expand the number and variety of diagnostic tests available in Singapore.


This provisional authorisation 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 the viral RNA) and the supporting validation data (e.g. Limit of detection, cross reactivity, inclusivity). Periodic reports on specific data on the safety and/or performance of these tests will be required to be submitted to HSA post authorisation to assure the continued performance of these devices. If any safety or performance issues are observed, HSA will require relevant follow up actions at the manufacturer’s end. 


This provisional authorisation has been implemented as an interim measure in response to the current public health need for timely detection of COVID-19 infections. If an applicant wishes to supply this test in the long  term, it must be registered with HSA. You can find more information on product registration here.


If you have any questions regarding this provisional authorisation process, please contact us here.


How to submit an application for Provisional Authorisation to HSA:


Email hsa_md_info@hsa.gov.sg with the subject ‘Provisional Authorisation’ with the following information:


  • A brief description of your test (test design, target biomarker, device technology, description of key functional elements, specifications, composition, accessories)

  • Intended purpose of your test

  • Information for Users (IFU) for the test

  • Summary of analytical validation (e.g. Limit of Detection, inclusivity, cross-reactivity, precision, interfering substances, Hook effect) and clinical data collected for your test where available

  • Summary of any planned or ongoing validation including clinical studies

HSA will get in touch with the applicant within 3 working days.

The Table below lists the COVID-19 tests that have received provisional authorisation to date. It will be updated as more tests gets approved:

HashTags: #Consumer, #Healthcareprofessional, #Industrymember, #Medicaldevices



source: hsa.gov.sg



0 views
  • LinkedIn - círculo blanco
  • Facebook - círculo blanco
  • Twitter - círculo blanco

© 2020 by Protect.sg.