P
Have been lurking around and now participating 
Due to Section 5.6.2 l) you have to assess how new or revised applicable regulatory requirements affect your QMS. Our NB annually asks of how we interpret such requirements.
I doubt though that deciding not to sell products (anymore) to a certain country based on more harsh requirements has to be part of the risk management file. It's mostly a business "risk" due to loss of income and maybe reputation.
As mentioned before, things differ from implantable devices imo due to re-surgery and the likes.
Due to Section 5.6.2 l) you have to assess how new or revised applicable regulatory requirements affect your QMS. Our NB annually asks of how we interpret such requirements.
I doubt though that deciding not to sell products (anymore) to a certain country based on more harsh requirements has to be part of the risk management file. It's mostly a business "risk" due to loss of income and maybe reputation.
As mentioned before, things differ from implantable devices imo due to re-surgery and the likes.