R
One of our clients is a medical device manufacturer who makes two versions of his product. The first version is CE marked and is distributed in the US and the EU. The second product is not CE marked and is unlikely to become so in the foreseeable future.
After a recent audit he was informed in no uncertain terms that he needed contracts with his agents in other countries.
His agent in Turkey had previously listed his CE marked product - no problems there. However they have been and wish to continue selling the non-CE marked product.
Per my client (an MD of course
) and his distributor in Turkey it is legal to market the product directly to physicians as that is not a regulated activity in Turkey.
If this is true I'd like to know this from someone actually familiar with the regulations there. If not I'd appreciate a reference such that I might be able to disavow my client of this notion.
Many thanks in advance,
Roger
After a recent audit he was informed in no uncertain terms that he needed contracts with his agents in other countries.
His agent in Turkey had previously listed his CE marked product - no problems there. However they have been and wish to continue selling the non-CE marked product.
Per my client (an MD of course
) and his distributor in Turkey it is legal to market the product directly to physicians as that is not a regulated activity in Turkey.If this is true I'd like to know this from someone actually familiar with the regulations there. If not I'd appreciate a reference such that I might be able to disavow my client of this notion.
Many thanks in advance,
Roger