Post Market Surveillance Requirements in Israel

Ronen E

Problem Solver
Staff member
Moderator
#11
Hello Ronen
Your posts are very interesting. I have found the Medical Equipment Act that was voted in May 2013. Are you aware of any regulations related to it? I know that MoH issued guidelines for registration submission but are you aware of anything regarding adverse events reporting?
Hello and welcome to the Cove :bigwave:

Please refer to the following thread for a more recent discussion.

http://elsmar.com/Forums/showthread.php?t=56666

Last time I checked (a couple of weeks ago) the regulations were not yet published in final, official form.

Cheers,
Ronen.
 
Elsmar Forum Sponsor
A

Anula

#12
Thanks so much for a quick reply!
I will be waiting then for any regulations to folow the act. I hope they will be issued soon and I hope they will be clear :). At the moment I find Israeli regulations very vague. Based on your experience, can you confirm that in case of foreign manufacturer without legal entity in Israel it is required that both are reporting adverse events: distributor in Israel and manufacturer himself? Also can you confirm that Israeli MoH wants to see all events worldwide (as opposite to these that happened in Israel)? That is what distributor tells me....
Sorry for numerous questions.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Thanks so much for a quick reply!
I will be waiting then for any regulations to folow the act. I hope they will be issued soon and I hope they will be clear :). At the moment I find Israeli regulations very vague. Based on your experience, can you confirm that in case of foreign manufacturer without legal entity in Israel it is required that both are reporting adverse events: distributor in Israel and manufacturer himself? Also can you confirm that Israeli MoH wants to see all events worldwide (as opposite to these that happened in Israel)? That is what distributor tells me....
Sorry for numerous questions.
Hi,

I don't have particular experience with commercial import of medical devices into Israel. I simply read the MoH publications and the applicable legislation (still not in effect although the Act was passed in Parliament in 2012).

Sorry,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#14
Just a quick update for anyone coming across this thread --

The Israeli Medical Equipment Regulations were officially issued on 12 June 2013, and came into force on 12 July 2013. they consist of about 5.5 pages in Hebrew; I'm currently not aware of an official English version. If anyone is interested in an unofficial (informed, though) translation -- feel free to send me a PM.

Cheers,
Ronen.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#15
Some clarification:

The Israeli Medical Equipment Act (2012) states that the requirement for registration prior to marketing will come into effect a year after the associated regulations come into effect. Since the Medical Equipment Regulations came into effect on 12 July 2013, the above requirement will come into effect on 12 July 2014.

Have a good week everyone,
Ronen.
 
D

depa1978

#16
Hi Ronen!!

And thanks for your support to the Covers!
Are you sure of this "transition period"?

I have an ongoing discussion with Israeli Distributor for one of my customers, and he is very disappointed as we are not shipping materials in Israel, waiting for the approval..:argue:
 

Ronen E

Problem Solver
Staff member
Moderator
#17
Hi Ronen!!

And thanks for your support to the Covers!
Are you sure of this "transition period"?

I have an ongoing discussion with Israeli Distributor for one of my customers, and he is very disappointed as we are not shipping materials in Israel, waiting for the approval..:argue:
Hi,

It is all in the State's records. The approval you are referring to is probably a remnant of the old system; however, the obligation to register under the 2012 Act is as I stated.

Just to let you know - the old requirement for "approval" is more a requirement of the hospitals, and the main procurement organizations that serve them. Government (State) hospitals are obliged by the Ministry of Health to only procure registered devices; For private organizations (not owned by the State) it is a matter of management decision. That is, until 12 July 2014.

Cheers,
Ronen.
 
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D

depa1978

#18
Thanks Ronen.

I can't send PMs yet as I am a shy poster :eek:
I will get back to you all once I have some news from Israel..

Thanks again.
Giovanni
 
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