Omega Diagnostics Group PLC Update on CTDA Regulations (1360R)
03 November 2021 - 6:00PM
UK Regulatory
TIDMODX
RNS Number : 1360R
Omega Diagnostics Group PLC
03 November 2021
3 November 2021
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
Update on new CTDA Regulations
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(R) professional-use 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(R) 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.
Contacts:
Omega Diagnostics Group PLC www.omegadx.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 omega@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Applegarth Mob: 07584 391 303
Sam Allen Mob: 07502 558 258
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
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