Coronavirus: Screening

(asked on 23rd May 2022) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason foreign-manufactured PCR tests are not subject to the same Coronavirus Test Device Approvals (CTDA) process to which UK manufactured tests must comply.


Answered by
Maggie Throup Portrait
Maggie Throup
This question was answered on 7th June 2022

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.

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