Different websites for different markets - FDA, Health Canada or other requirements

med_cert

Involved In Discussions
#1
If we have different approvals (different intended use, indications for use) on different markets, should we have different websites for each specific market (which is different than "international") or the disclaimer/footnote on the webside (draft example: "...this website is for EU... for countries where specific national approvals or clereances are required some applications may not have been cleared yet...please check by the manufacturer or your national regulatory body to find the applications that are available for sale and use...") should be sufficient?

Does anyone know any requirement (FDA, Health Canada or others) related to this?
 
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pkost

Trusted Information Resource
#3
As you recognise, you have to be careful about advertising claims that you do not have approval for in that market.

I would suggest a site with location based IP lookup to push people to the correct part of the site and an initial tab at the top that says that "we have detected that you are in Europe - please click here to change this and to ensure that you receive information appropriate to your location"

The only requirement is that you must not make claims that are not approved, how you do that i believe is at your descretion. By having a footnote saying that some claims have not cleared yet I personally think is still at risk of suggesting your are still promoting the off label use; also, authorities may take the view that the footnote is too small and non obvious
 

med_cert

Involved In Discussions
#4
As you recognise, you have to be careful about advertising claims that you do not have approval for in that market.

I would suggest a site with location based IP lookup to push people to the correct part of the site and an initial tab at the top that says that "we have detected that you are in Europe - please click here to change this and to ensure that you receive information appropriate to your location"

The only requirement is that you must not make claims that are not approved, how you do that i believe is at your descretion
And you believe the footnote would not be sufficient? Where is the limit then? We sell our devices in more than 50 countries... many of them have some specifics...
 

pkost

Trusted Information Resource
#5
My comment was a personal opinion and not fully grounded in verifiable legislation/guidance. Your original post mentioned FDA who I know to be quite strict on marketing claims and where I wouldn't want to rock the boat too much. However if you are in 50 countries, I'm sure some of them are less strict

I do not know what your product is or how your website works, however in the past I have used a database with each claim as a record and then an entry as to whether the claim is suitable for which markets

When the content is pulled, the website filters out any claim that is not suitable for the relevent market. It's relatively trivial to implement
 
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