To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the effectiveness of the UK Health Security Agency’s Coronavirus test device approval (CTDA) process for covid-19 diagnostics, in helping UK manufacturers to be world-leaders in clinical diagnostics delivery.
To ask the Secretary of State for Health and Social Care, if he will make It his policy to provide applicants to the Coronavirus Test Device Approvals (CTDA) service with weekly status updates on their applications.
The Coronavirus Test Device Approval (CTDA) validation process has ensured that the highest quality COVID-19 tests are available on the United Kingdom market. As of 24 May 2022, 244 applications for review under CTDA regulations have been received, with 143 or 58% originating from manufacturers in the UK. The CTDA validation process applies equally to both foreign and domestic manufacturers.
While there are no plans to provide specific weekly updates, the UK Health Security Agency (UKHSA) frequently communicates with applicants through its dedicated review and complaint channels. The UKHSA keeps the CTDA process under continuous review and will consider further improvements for applicants.