PV Bulletin

COVID-19 Test Approval: Introduction of CTDA Renewal Process and Portal

The MHRA has established a formal renewal process and a new application portal for maintaining approvals for COVID-19 diagnostic tests in the UK.

Primary source: Standard CTDA pathway: process for desktop review

PV Impact Brief

Urgency: HighConfidence: high

What changed

The introduction of a CTDA renewal process requiring manufacturers to apply for renewal through a new digital portal, starting from 13 August 2026.

Why it matters

This change enhances ongoing oversight and compliance by mandating periodic re-validation of tests, thus ensuring continued safety and efficacy in the market amid evolving standards.

Action needed

Manufacturers must submit renewal applications for CTDA certificates with a £420 fee (discounted to £168 for small organizations) and respond to any requests for additional information within 20 working days.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Guidance
Policy status
Updated
Publication date
2021-07-28
Last updated
2026-08-13
Policy change
The MHRA has introduced a formal renewal process and a new application portal for the Coronavirus Test Device Approvals (CTDA). This update provides a structured pathway for manufacturers to maintain their approvals for COVID-19 diagnostic tests on the UK market.

Key changes

Introduction of a formal renewal cycle for COVID-19 test approvals; launch of a new digital portal for renewal applications; updated documentation requirements for demonstrating ongoing compliance and safety.

Affected workflows

Country Compliance

Responsible groups

Medical Device VigilanceRegulatory Affairs

PV impact

The new renewal process enhances post-market oversight by requiring periodic re-validation of approved test devices. This systematic approach ensures the ongoing monitoring of safety and performance, requiring manufacturers to maintain robust vigilance data to support renewal applications.

View regulator source

Source document details

Exact policy details

CTDA Renewal Process Introduction Date
13 August 2026
Applies to: Effective from this date for obtaining renewal of CTDA certificates.
Last updated date in document. · p. 1 · High · Source
Renewal period for CTDA certificates
Five years
Applies to: Extension period for CTDA certificates under the renewal process.
This CTDA renewal process will extend CTDA certificates for a further five-year period. · p. 1 · High · Source
CTDA Renewal Application Fee (Full Price)
£420
Applies to: Fee for organizations applying for CTDA certificate renewal.
The fee will depend on the size of the organisation applying for renewal. · p. 1 · High · Source
CTDA Renewal Application Fee (Discounted Price)
£168
Applies to: Discounted fee for organizations with no more than 250 individuals.
You can apply for the discounted price if your organisation has no more than 250 individuals in total. · p. 1 · High · Source
Deadline for application response during desktop review
20 working days
Applies to: Timeline for applicant to respond to MHRA requests for additional information.
If we need more information from you during the desktop review...you must respond within 20 working days. · p. 1 · High · Source
Expected implementation of Medical Devices (Amendment) Regulations 2026
Mid-2027
Applies to: Timeline for the introduction of new Common Specification requirements.
The SI is expected to come into force in mid-2027. · p. 1 · High · Source

Workflow rule impacts

Country ComplianceManufacturers of COVID-19 test devices

Manufacturers must prepare for a streamlined renewal process to ensure continued market access.

Introduction of the CTDA Renewal Process.

Manufacturers whose CTDA certificates are due to expire soon may apply for the CTDA Renewal Process. · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 13, 2026

Full briefing

Practical implication

Manufacturers must submit renewal applications for CTDA certificates with a £420 fee (discounted to £168 for small organizations) and respond to any requests for additional information within 20 working days.

The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented a structured renewal process for the Coronavirus Test Device Approvals (CTDA). This includes a new digital portal for applications, updated compliance documentation requirements, and a formal re-validation cycle to enhance post-market oversight and safety monitoring of COVID-19 diagnostic tests.

What changed: The introduction of a CTDA renewal process requiring manufacturers to apply for renewal through a new digital portal, starting from 13 August 2026.

Why it matters: This change enhances ongoing oversight and compliance by mandating periodic re-validation of tests, thus ensuring continued safety and efficacy in the market amid evolving standards.

Practical implication: Manufacturers must submit renewal applications for CTDA certificates with a £420 fee (discounted to £168 for small organizations) and respond to any requests for additional information within 20 working days.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Medicines and Healthcare products Regulatory Agency (MHRA)#policy-change#Guidance#firecrawl-policy-agent#Updated

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