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Member input required for Coronavirus Test Device Approvals consultation

By September 16, 2022No Comments

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 and should be reported by 31 December.

It is quite a detailed consultation, and covers the following areas:

  • costs for individual businesses involved in the domestic COVID-19 test kit sector
  • scale and nature of domestic COVID-19 test kit activity, including manufacturing and trading
  • scale and nature of activities abroad which are integral to our existing domestic COVID-19 test kit supply and market
  • the direction of the COVID-19 test kit market
  • how the CTDA objectives have been met and if they could be met more efficiently in future


To inform the BIVDA response, we would be grateful for members involved in the CTDA process to provide information on these topics to Ashleigh by Friday 7 October. We would also strongly encourage members to respond to this consultation directly and would welcome receiving any full responses submitted.

Natalie Creaney