Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what comparative assessment his Department has made of the impact of the coronavirus test device approvals (CTDA) process on (a) domestically- and (b) foreign-manufactured covid-19 tests which are not subject to the CTDA process.

The coronavirus test device approval (CTDA) is required for all molecular and antigen tests to enter the United Kingdom market. Non-antigen and non-molecular detection tests such as antibodies or biomarker-based testing technologies are currently excluded from the scope of validation. However, these will be monitored and revised as necessary, particularly as technologies become more mature and widespread. Regardless of the country of origin, all tests must meet the standards established in the CTDA regulations.

The ‘Validating COVID-19 tests in the private market’ has assessed the impact of CTDA for UK based and international companies and is available at the following link:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1053516/Validating_COVID_19_tests_in_the_private_market.pdf

Further to the legislation, we have committed to review this policy by the end of 2022.