COVID-19 test approval: how to apply
How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.
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 will introduce an accelerated CTDA process for COVID-19 test devices that:
- Are CE-marked under EU IVDR, and
- Meet the Common Specifications requirements.
This pathway allows qualifying tests to undergo a more streamlined desktop review to confirm compliance with regulatory, performance, and safety requirements.
Step 1: submit your application
Manufacturers or distributors can submit a CTDA application to the MHRA 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.
- Full price: £14,000
- Discounted price: £6,200
You can use the following types of payment:
- credit or debit card
- wallet payment
No alternative payment method is accepted.
If you are having difficulty with the payment methods, email ctda@mhra.gov.uk.
If you withdraw from the process after you have made the payment, it will not be refunded.
Fees are the same worldwide and are taken in GBP.
The application will require information on:
- the manufacturer and COVID-19 test product
- regulatory status
- product performance
- biosafety
- supplementary documents (for example, current version of the instructions for use, biosafety documents, evidence of performance characteristic)
Step 2: desktop review
The desktop review will assess each CTDA application against all criteria set out in the CTDA guidance below:
- For the standard CTDA pathway, see guidance.
- For the accelerated CTDA pathway, see .
- A list of recommended acceptable comparator assays is available here: .
The assessment is done in 3 stages:
- A scientific adviser reviews it.
- The desktop review assurance group reviews the initial assessment.
- The regulatory approvals committee reviews the assessment and issues the final recommendation.
If we need more information from you during the desktop review, the MHRA will reach out to the named person on the application and you must respond within 20 working days. If you do not respond within 20 days, your application may be rejected.
Outcome reporting
We only publish details of tests that have passed the CTDA process, showing:
-
name of test
- name of manufacturer and business address
- name and business address of person who made application (if different to the manufacturer)
- date and version of the approved instructions of use
- type of test
- date of approval
- date the approval will cease
- other regulatory status and certification number
- country of manufacture
- approved sample type
Applicants appearing on the list must not use the name of the MHRA, or any Crown Body, to show preference to their products, services, or research.
Complaints
Applicants who want to complain about the process should email ctda@mhra.gov.uk.
You must include a full summary of the complaint and any supporting information you consider relevant.
Updates to this page
-
Introduced the CTDA accelerated pathway and updated desktop review guidance
-
Added links to COVID-19 test approval step 2: process for desktop review and list of comparator assays.
-
Updated notice on change to the application process.
-
Added notice explaining the upcoming change to the application process.
-
Updated information about the desktop review.
-
Updated email addresses.
-
Added an email address (CTDA@dhsc.gov.uk) for those having difficulty with the payment methods.
-
Added link to 'COVID-19 test approval – step 2: process for desktop review'. Under 'Output reporting' added 'sample types' to the list of information that DHSC will publish for tests that have passed.
-
Removed test performance guidance and technologies validation group guidance.
-
First published.