Skip to main content
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Government publishes review of the Coronavirus Test Device Approvals (CTDA) process

By January 13, 2023No Comments

On 29 December, the UK Health Security Agency published their statutory review of the CTDA process.

The CTDA process was introduced to ensure that antigen and molecular Covid-19 tests were assessed for performance before being put into the UK market, intending to increase the quality of UK tests.

The overarching theme of the review is summarised:

It is clear that the CTDA has met its principal and overall objective of improving the quality of tests on the UK market and has successfully addressed the market failure that saw poor quality, inaccurate tests made available for sale. A large number of tests have now successfully passed through the process, indicating a robust market that gives consumers genuine choices.


Whilst the process for approving tests was initially slower than planned, the speed has increased significantly, and the quality of applications has improved as the CTDA regime has matured.

This is in keeping with the conversations had throughout the process between BIVDA and UKHSA.

Notably, this review also implies that the assessment team for approving CTDA applications is likely to be moving to MHRA in the future. No additional details are provided on this move within the review. This indicates that the CTDA process or alternative pandemic preparedness may be included within the new UKCA Regulations. Whether this will be removal of the process, continuation of the current process, or amendments to the process remains to be seen.

If you have any questions or wish to discuss this review, please contact Ashleigh.

Natalie Creaney