At MHRA biosure has a registration and product listed as class 1 Device but Starpharma don't have product as still using CE ? The old CE IMO " loophole" was changed in 2021 with transition process and may be able to be used / sold until 2030 if conditions are met . The aftermarket study IMO forms part of that and is why it was a bare bone study to keep it uncomplicated rather than IMO one that would possibly support TGA ?
Class 1 being lowest and in regards to advertising standards and packaging it appears to be self assessment with a big proviso that you must be able to verify all claims. ASA is the body that monitors advertising in compliance with MHRA laws.
https://www.asa.org.uk/advice-online/health-medical-devices.html
MHRA registrations
https://aic.mhra.gov.uk/era/pdr.nsf/vwLkupFileRef/23226?opendocument
Nasal mucosa infection control gel Class 1MHRA Reference Number: 23226
Date Registered: 23/02/2022
https://pard.mhra.gov.uk/manufacturer-details/54791
Starpharma
Couldn't find viraleze listed
At MHRA biosure has a registration and product listed as class 1...
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