"Isn’t this a strange time for the UK to bring in this new regulation? Right before the Winter surge,"
It's political and a result of the p1$$ poor system of travel testing. This comes as a result of pressure from consumer groups (as people were being ripped off) and the travel industry.
" I’m wondering how many Chinese tests are on the approved/temporary approved list? "
The exemption list basically contains those tests that got through Porton Down or which were subject to an extant EUA.
"Good post Tricky . Do you know if the list is dynamically updated or at set points in time ?
Have you got a link to the spreadsheet they issued ?"
The approved devices list can be found here: https://www.gov.uk/government/publications/covid-19-test-validation-approved-products
The approved list was was last updated 29 October. They don't say how often it will be updated.
The exemptions list is included in the Protocol: https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol
This appears to have been updated today.
"In the meantime the UK CBTA regulations do not apply to the DHSC test- special derogation para 34a of the amended legislation. "
Just to be pedantic, it's not regulation 34A but regulations 34B and 39.
"An observation:
“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 statement refers to *all* suppliers and not just Omega and, 31 October 2021 is the last date on which you can sell your test prior to the CDTA regulation coming into force on 01 November 2021. For reference, Novacyt's similar statement:
“Only validated products, or products on the temporary protocol, can be sold in the UK after 31 October 2021”.
As pointed out yesterday, that's not quite right.
The CTDA requirements do not apply to all Covid-19 tests, as Regulations 34B and 39 clearly indicate.
"The avacta fan boys are here today as they are concerned we have a deal signed before them. Its actually not surprising because if I worked for a distributor/ healthcare body the first thing I would want to see would be validation data by third parties. Mologic have FIND a highly reputable independent party globally. Avacta don't even name their validation partner (highly suspicious)"
Very well put tecbadger...
"I thought Dam partnership released 1/11 ?"
You are indeed correct.
I do also suggest that people read the CTDA Regulations. They're not very long and quite self explanatory (if you understand the structure of these types of regulations). They can be found here: https://www.legislation.gov.uk/uksi/2021/910/contents/made
"Omega clearly asleep releasing the same RNS as Novacyt and Avacta 24 hours later."
I'd suggest more a case of ODX having to respond (once again) to misinformation being shared by people trying to manipulate the share price....
"Omega submitted before 1st October
Avacta submitted before 1st September"
Where does the RNS say that Omega submitted before 1 October? It simply says that it submitted the before the final deadline of 31 October 2021 (which is the correct deadline, unlike the suggestion in the Avacta that the deadline was 1 September - it wasn't).
Why are you making things up?
"Good luck with that flimsy external validation data"
*Snork*
Norty tecbadger...
"Ps the gov and DHSC have got no idea for they are fcking doing either.."
Yebbut... our lives would be a bit boring if they did. ;-)
"Don't forget UKCA regulator ! It's going to be a fun few years for the IVD industry
And by fun I mean like putting needles into your eyes."
This sort of stuff does keep me employed... ;-)
"It is a bit confusing having two lists of tests, yet that not being all the tests that can be sold - you would have thought that having one version of the truth would have been simpler?"
The problem is that you will get these sort of anomalies if you change authorisation processes in the piecemeal way that the government has. This is a good case study on incompetence...
EDIT: In fact, you're going to end up with at least* three lists:
- those tests the CTDA doesn't apply to;
- those tests exempted under CTDA (which is different from the CTDA not applying); and
- those approved under CTDA.
And top of all this, we also have the new MDR tribulations (as outlined here previously by @tecbadger) to look forward to.
*I'm assuming, in the interests of public safety DHSC may also publish a list of those who were not authorised under CTDA, and those whose authorisation has been withdrawn, in a similar way to the FDA or the EUMA.
"dont say you were not warned. Will stay away till news comes out and then those who have called me a troll can apologise."
Off you pop then, Chuckles. Don't let the door hit ya where the good Lord split ya...
"It is a bit confusing having two lists of tests, yet that not being all the tests that can be sold - you would have thought that having one version of the truth would have been simpler?"
The problem is that you will get these sort of anomalies if you change authorisation processes in the piecemeal way that the government has. This is a good case study on incompetence...
"If you understand the legalities, perhaps you might want to refrain from commenting and making yourself look (even more) stupid?"
That should, of course, read: "If you don't understand the legalities..."
"So is Visitect on the government approved list?"
It doesn't have to be for the professional POC test, as the CTDA regulations make clear.
If you understand the legalities, perhaps you might want to refrain from commenting and making yourself look (even more) stupid?
"I think I remember you mention the Marketing thing before - isn't that where you can have a CE mark, but until you are allowed to Market, you can't sell? I think that is supplied by DHSC isn't it?"
Pre-CTDA the process was:
- manufacturer or Notified Body CE marks IVD (generally only for professional POC unless one of a small group of self-use IVDs identified in the MDD/MDR regulations
- manufacturer notifies competent authority of CE marking and applies for marketing authorisation (in the UK the competent authority is MHRA)
When it came to Covid, you could not CE mark an IVD for self-use using the above process. Further authorisation was required from the competent authority. In the UK this was being done via Emergency Use Authorisations and the Porton Down assessment process.
The CTDA is intended to replace the Porton Down process and provide a clear statutory basis for marketing authorisations in the UK of Covid IVDs going forward. Bascially the SoS/DHSC will nominally manage a process (undertaken by HSA and MHRA) for market authorisations. There also remains the capacity for exemptions.
"The personal attacks are not warranted when I am simply stating facts as i see them."
You're not "stating facts" - you're giving your opinion...
...an opinion that appears to be based on a lack of understanding of the facts.
"They said y'day that they had an Initial Purchase Order for £750k..that still stands despite your efforts."
Yep.
I'll just repeat for the hard of understanding.
The CTDA Regulations *do not* apply to the Visitect Professional POC test, as it was CE marked and had market authorisation prior to 1 September 2021. It is that Professional POC test which is being sold to DAM Health at this time.
The CTDA Regulations *will not* apply to any test selected by the government for supply under the DHSC contract.
"Agree - requires clarification have Omega submitted desk top application at PD?
I could be wrong here and this is a total guess but I wonder if the BOD are expecting HUA EU within days and are holding out ?
Could be?
There's no requirement for ODX to clarify anything.