Update on new CTDA Regulations
03 November 2021
Omega (AIM: ODX), the specialist medical diagnostics company focused on industry-leading Global Health (CD4 and COVID-19) and Health and Nutrition products, notes the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA”) which were implemented on 1 November 2021.
The new CTDA Regulations required all suppliers of COVID-19 tests to submit information regarding their products for desktop review prior to 31 October 2021 if they wished their products to remain on sale in the UK after this date. This is a new requirement over and above the requirement for the CE Mark secured for Omega’s VISITECT® professionaluse COVID-19 Antigen test (“LFT”) earlier this year.
Omega submitted all documentation ahead of the published deadlines and paid the necessary fee, however, in line with the vast majority of available tests on the market Omega’s existing LFT has yet to be approved under CTDA.
This new legislation is not expected to cause a delay in the supply of Omega’s VISITECT® professional-use COVID-19 Antigen test to DAM Health clinics in the UK under the agreement announced on 1 November 2021. Omega currently remains free to supply LFTs to DAM Health's clinics throughout Europe and DAM Health are able to distribute Omega’s LFT throughout Europe.
The Company will update shareholders as soon as they receive a further update from the UK Health Security Agency.
|Omega Diagnostics Group PLC||www.omegadiagnostics.com|
|Colin King, Chief Executive||via Walbrook PR|
|Chris Lea, Chief Financial Officer|
|finnCap Ltd||Tel: 020 7220 0500|
|Geoff Nash/Edward Whiley (Corporate Finance)|
|Alice Lane/ Charlotte Sutcliffe (ECM)|
|Walbrook PR Limited||Tel: 020 7933 8780 or [email protected]|
|Paul McManus||Mob: 07980 541 893|
|Lianne Cawthorne||Mob: 07584 391 303|
About Omega Diagnostics Group PLC
Omega manufactures and distributes high quality in-vitro diagnostic products for use in hospitals, clinics, laboratories and healthcare practitioners in over 75 countries and specialise in the areas of health and nutrition and global health.www.omegadx.com