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Guidance: COVID-19 test validation approved products

Medicines Healthcare Products Regulatory Agency

January 25
15:12 2024

Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations

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Details

Use the coronavirus (COVID-19) test validation approved products document to find out which products have been approved under Regulation 38A(5) of the Medical Devices Regulations 2002.

Read the COVID-19 test approval: how to apply guidance to find out more about the validation methodology and application process.

Read the policy review of the Coronavirus Test Device Approvals (CTDA) process, published in December 2022.

Published 18 October 2021
Last updated 25 January 2024 +show all updates
  1. COVID-19 test validation approved products spreadsheet updated.

  2. Uploaded new Products approved under the Medical Device Coronavirus Test Device Approvals Amendment Regulations list as an excel spread sheet

  3. The 'COVID-19 test validation approved products' file has been updated.

  4. Published updated 'COVID-19 test validation approved products'

  5. COVID-19 test validation approved products spreadsheet updated.

  6. Published updated 'COVID-19 test validation approved products' data.

  7. The correct spreadsheet of COVID-19 test validation approved products has been uploaded.

  8. Updated 'COVID-19 test validation approved products' to July 2023.

  9. Updated 'COVID-19 test validation approved products' file.

  10. Updated 'COVID-19 test validation approved products' file.

  11. Updated the register.

  12. Updated the register.

  13. Updated the register.

  14. Updated the register.

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