COVID-19 test approval: how to apply

Change to the application process

Manufacturers or distributors supplying COVID-19 tests must apply to the UK Health Security Agency (UKHSAMHRA). for approval. Their product must meet the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021.

During the approval processprocess we will UKHSA 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,application, we will UKHSA 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 howhow we will UKHSA will assess your test, see COVID-19 test approval – step 2: process for desktop review (PDF, 237 KB, 12 pages).

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:

1. A scientific adviser reviews it.
2. The desktop review assurance group assesses the submission.
3. The regulatory approvals committee then considers it.

UKHSAA list of suitable comparator assays is available: MHRA suitable comparators (ODS, aims16.3 KB).

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.applications. We will UKHSA will prioritise certain applications where necessary, for example if it’s in the interests of public health.

IfIf we need UKHSA needs 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.

You can use the following types of payment:

• credit or debit card
• wallet payment

If you are having difficulty with the payment methods, email ctda@ukhsa.gov.ukctda@mhra.gov.uk.

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

UKHSAWe only publishespublish 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 ofof the UKHSAMHRA, or any Crown Body, to show preference to their products, services, or research.

Complaints

Applicants who want to complain about the process should email ctdacomplaints@ukhsa.gov.ukctda@mhra.gov.uk.

You must include a full summary of the complaint and any supporting information you consider relevant.

Reviews

If your application is unsuccessful, you can requestrequest that UKHSAMHRA toreconsiders reconsider its decisiondecision, by using the web form in the service.