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Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Coronavirus Test Device Approvals Transition

The UK Coronavirus Test Device Approvals function is currently managed by UKHSA. The MHRA will take over this function from 24 May 2023. A guidance confirming the changes to process management will be published by the MHRA on 24 May. The MHRA have provided the following information: The UK Coronavirus Test Device Approvals regulatory regime is one of the most…
May 12, 2023
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Government publishes review of the Coronavirus Test Device Approvals (CTDA) process

On 29 December, the UK Health Security Agency published their statutory review of the CTDA process. The CTDA process was introduced to ensure that antigen and molecular Covid-19 tests were assessed for performance before being put into the UK market, intending to increase the quality of UK tests. The overarching theme of the review is summarised: “It is clear that…
Natalie Creaney
January 13, 2023
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Member input required for Coronavirus Test Device Approvals consultation

UKHSA have published a consultation on the CTDA process for covid-19 products. This consultation will run until 18 October 2022, and BIVDA intends to supply a response on behalf of the membership. The aim of the consultation is to support understanding of the impact the CTDA process had on the market. A wider statutory review of this policy is planned…
Natalie Creaney
September 16, 2022