Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 15 February 2022 to Question 119864, what the evidential basis is for the statement that (a) approval of covid-19 tests for private use falls under the Coronavirus Test Devices Approvals regulation (CTDA) and (b) only devices that meet the high regulatory standards are available to the British public, in the context of known Chinese-manufactured tests that have not been assessed under the CTDA process.

The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA) provides a regulatory framework for manufacturers and their representatives seeking to sell COVID-19 tests in-scope of the legislation on the private market or supply tests to private sector testing services in the United Kingdom. It establishes standards to protect consumers and enable high quality tests to enter the market, regardless of the country of origin.

A test must either be approved under the CTDA or be included in a protocol that lists tests that are allowed to remain on the market while their CTDA application is being processed. Tests on the protocol list have received a form of verification, evaluation or validation elsewhere in the public sector, therefore their performance expected to be sufficient to protect public health. The protocol is a temporary measure and long-term access to the UK market is achieved only via CTDA approval.