Israel Medical Device registration

B

bisbita

#1
Hello guys, it is nice to be here.

First of all, I am here to help and get some help.

I am seeking for the requirements/information to register a MD in Israel,

Thanks in advance!
 
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Ronen E

Problem Solver
Moderator
#2
Hello bisbita and welcome to the Cove :bigwave:

Look for the Google search box built-into this webpage, on the upper left hand corner. Type in "Israel" and you will find multiple threads where I provided lots of information about MD regulation in Israel.

If you still have questions, please come back and I'll try to assist.

Cheers,
Ronen.
 

tibon74

Involved In Discussions
#3
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.
 

maya_tanase

Starting to get Involved
#4
Hello everybody,
I am asking you for advice you on behalf of a Client of ours, an Italian manufacturer, in need of some information regarding the Israeli Registration Holder, IRH. The questions I have are aimed at understanding if the manufacturer is free or is able to free themselves from the entity (local distributor, for instance) who requests the product registration as IRH, should the partnership with this entity turn out to be unreliable and/or unprofitable.

More specifically:
1) Can the same product be registered several times by different people/IRH at the same time?
2) If the (foreign) manufacturer decides to designate a certain entity (for instance, the local distributor) as their IRH to proceed with the registration of the medical device, would it be possible to switch this person in the future without the IRH’s consent? In such case, would the registration of the product remain valid? Or would the manufacturer need to designate a new IRH and request a new product registration?

I am grateful for any piece of information you may be able to provide me (and hope to reciprocate in the near future).
Best regards,
Maya Tanase
 
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