COVID-19 test approval: how to apply

Coronavirus (COVID-19) test devices in the UK must apply for approval and meet the requirements set out in the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021.

From 24 May 2023, the management of the Coronavirus (COVID-19) test device approval (CTDA) process moved from the UK Health Security Agency (UKHSA) to the Medicines and Healthcare products Regulatory Agency (MHRA).

On 10 July 2025, the Government announced plans to remove the CTDA process, replacing it with Common Specification requirements for COVID-19 test devices. In the interim, the Government has introduced an Accelerated CTDA pathway for COVID-19 test devices that:

This pathway allows qualifying tests to undergo a more streamlined desktop review to confirm compliance with regulatory, performance, and safety requirements.

Under the draft Medical Devices (Amendment) Regulations 2026 Statutory Instrument (SI), coronavirus test devices with a valid CTDA certificate will have until the earlier of either five years from the date the SI comes into force, or the expiry date of their CTDA certificate, to comply with the new Common Specification requirements. The SI is expected to come into force in mid-2027. Manufacturers whose CTDA certificates are due to expire soon may apply for the CTDA Renewal Process to maintain compliance and continued market access during the transition period introduced by the SI.

Manufacturers or distributors can submit a CTDA application to the MHRA for a new CTDA certificate via the Coronavirus (COVID-19) test device approvals service portal and pay the application fee.

The cost depends on the size of the company applying for validation. You can apply for the discounted price if your company has no more than 250 individuals in total.

You can use the following types of payment:

No alternative payment method is accepted.

If you are having difficulty with the payment methods, email [email protected].