Selling Medical Devices from the US into Israel

[Putnam]

Is there any reason a medical device manufacturer located in the US (FDA and ISO 13485) would also need ISO 9001 in order to sell into Israel?

 

[Ronen E]

No, there isn't. Not a regulatory one, at least.

 

[tibon74]

Hi guys,
Could we import a medical device in Israel while the registration file is still being reviewed by MOH? it means that it is not approved yet.
is there any process (special access, temporary importation...) allowing that ?
thank you !