COVID-19 test approval: how to apply
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
From 24 May 2023, the management of the Coronavirus (COVID-19) test device process (CTDA) moved from the UK Health Security Agency (UKHSA) to the Medicines and Healthcare products Regulatory Agency (MHRA). Applicants will need to provide MHRA with the same data currently requested for all CTDA submissions.
Details of the changes are below.
Applications received up to 21 May 2023
Existing applications will remain with the UKHSA CTDA team. If you have any enquiries or updates, it's important that you continue to contact UKHSA at [email protected].
Applications received on or after 24 May 2023
MHRA will manage all new applications submitted on or after 24 May 2023. New applicants from 24 May should email MHRA with any enquiries at [email protected].
Manufacturers or distributors supplying COVID-19 tests must apply to MHRA. Their product must meet the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021.
During the approval process we will keep you updated on your application’s progress. This guide sets out each stage of the process you must follow.
Step 1: submit your application
After you submit your application, we will do a basic check to make sure it includes the required information to make sure that:
- all the required fields on the application are complete
- appropriate responses and attachments are included
- you have paid the fee
The main areas of basic check are:
- manufacturer and product information
- regulatory status
- product performance
- biosafety
- supplementary documents (for example, current version of the instructions for use, biosafety documents, evidence of performance characteristic)
For more details about how we will assess your test, see .
Go to the Coronavirus (COVID-19) test device approvals service to begin your application for COVID-19 test approval.
Step 2: desktop review
This review assesses the evidence a supplier submits against a minimum required data set.
This step prevents products that are below the expected standards from progressing to the market as set out in the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021. The assessment is done in 3 steps:
- A scientific adviser reviews it.
- The desktop review assurance group assesses the submission.
- The regulatory approvals committee then considers it.
A list of suitable comparator assays is available: .
We aim to provide an initial response or acknowledgement of receipt within 20 working days, but this may take longer if there’s a high volume of applications. We will prioritise certain applications where necessary, for example if it’s in the interests of public health.
If we need more information, you must respond in 20 working days. If you do not respond within 20 days, your application might be rejected.
Payment
You must pay for approval. 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.
| Payment stage | Full price | Discounted price |
|---|---|---|
| Desktop review | £14,000 | £6,200 |
You can use the following types of payment:
- credit or debit card
- wallet payment
If you are having difficulty with the payment methods, email [email protected].
A colleague will do their best to help you.
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.
Outcome reporting
We only publish details of tests that have passed, showing:
- indicative performance category
- 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 for instructions of use
- type of test
- date of approval
- CE certification number
- country of manufacture
- 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 [email protected].
You must include a full summary of the complaint and any supporting information you consider relevant.
Reviews
If your application is unsuccessful, you can request that MHRA reconsiders its decision, by using the web form in the service.
Updates to this page
Published 28 July 2021Last updated 24 May 2024 + show all updates
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Added links to COVID-19 test approval step 2: process for desktop review and list of comparator assays.
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Updated notice on change to the application process.
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Added notice explaining the upcoming change to the application process.
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Updated information about the desktop review.
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Updated email addresses.
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Added an email address ([email protected]) for those having difficulty with the payment methods.
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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.
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Removed test performance guidance and technologies validation group guidance.
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First published.