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The applicationmain willareas requireof informationbasic on:check are:

• the manufacturer and COVID-19 test product information
• 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

TheFor desktopmore reviewdetails willabout how we will assess eachyour CTDAtest, applicationsee against all criteria set out in the CTDA guidance below:

• ForCOVID-19 thetest standardapproval CTDAstep pathway,2: seeprocess CTDAfor destopdesktop review guidance V4 (PDF, 303237 KB, 12 pages).

  Go guidance.

• Forto the acceleratedCoronavirus CTDA(COVID-19) pathway,test seedevice CTDAapprovals acceleratedservice pathwayto desktopbegin reviewyour guidanceapplication V3 (PDF,for 281COVID-19 KB,test 12approval.

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  This recommendedreview acceptableassesses comparatorthe assaysevidence isa availablesupplier here:submits MHRAagainst CTDAa suitableminimum comparators (ODS,required 16.3data KB).

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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 stages:steps:

1. A scientific adviser reviews it.
2. The desktop review assurance group reviewsassesses the initial assessment.submission.
3. The regulatory approvals committee reviewsthen theconsiders assessmentit.

A andlist issuesof thesuitable finalcomparator recommendation. assays is available: MHRA suitable comparators (ODS, 16.3 KB).

If we needWe moreaim informationto fromprovide youan duringinitial theresponse desktopor review,acknowledgement theof MHRAreceipt willwithin reach20 outworking todays, thebut namedthis personmay ontake longer if there’s a high volume of applications. We will prioritise certain applications where necessary, for example if it’s in the applicationinterests andof public health.

If we need more information, you must respond withinin 20 working days. If you do not respond within 20 days, your application maymight 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 ctda@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

We only publish details of tests that have passed, the CTDA process, 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 offor the approved instructions of use
• type of test
• date of approval
• dateCE 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,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.