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Israel: 1 Medical Device, Multiple Registrations = Possible?

3

3l5m4r

#1
Hi there,

Well- I guess, the title says it all: Is it possible to register the same medical device more than once in Israel? (only difference would be the Registration holders)

I've heard multiple answers, but none of them was based on any form of evidence (e.g. an official document). Is there anyone out there who knows whether there's any official statement implying that this is / is not possible?

I'd be glad, if someone could help me out with this (ideally asap)... ...thx
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi there,

Well- I guess, the title says it all: Is it possible to register the same medical device more than once in Israel? (only difference would be the Registration holders)

I've heard multiple answers, but none of them was based on any form of evidence (e.g. an official document). Is there anyone out there who knows whether there's any official statement implying that this is / is not possible?

I'd be glad, if someone could help me out with this (ideally asap)... ...thx
Hi,

I've done a quick review of the law, the regulations and the explanatory publications in the Israeli Ministry of Health website, and I couldn't find any explicit statement in that regard (either way).

the law and regulations language implies that there could be multiple registrations / registration holders for the same device; however I felt like that option was slightly overlooked and some of the details are not 100% consistent with multiple registrations, or there's at least some grey area.

Please note that the above is the result of a rather quick and informal review. A full, formal review, concluding in a well-renationalised report (including specific legal source pointers) would take several hours. Please PM me if that's what you are after.

Cheers,
Ronen.
 
3

3l5m4r

#3
@Ronen: thanks a lot for your efforts.

well, i guess it doesn't help a lot, if that has been overlooked so far and would theoretically be possible, but might then actually result in a rejection...
...there seems to be no other option than to try and submit...

i'll keep you up to date as soon as i can share any experiences or somehow learn something new any other way...

-3l5m4r
 
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