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Possibility for Medical Device registration in Israel Regulation

#1
Hi guys!

My company is Class III implantable medical device manufacturer located in non-GHTF country.

Our product is CE certified from Turkish notified body under MDD.

1. In this case, is it impossible to register our product in Israel?
(There were some information registration in Israel is not possible if the product is certified in non-western notified body.)

2. According to my survey, Israel also requires 'sufficient amount' of sales data in recognized countries.
How much is this 'sufficient amount'?
If you have any experience, please share us.

It's really hard to get information about Israel medical device regulation.
Please help me T.T
 
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RA_QA_Expert

Involved In Discussions
#2
Hi,

the first point is mandatory for all clases of medical devices.

Israel has the list of recognized only western notified bodies and auditing organizations.
Even class I medical device manufacturer must be certified acc.to ISO 13485 only by western organizations.

I believe that it is impossible to register medical device with Israel MOH without certificate from western NB.

Honestly, I'm not experienced with class III devices, but lower classes can be registered based on registration in other country like USA, Canada or Australia. If you introduce your device in other countries (exept EU), you should ask your registration parner to check whether you can use such approval.

Or you can change your NB.
But it is big challenge now :)
 

Mikilk

Involved In Discussions
#3
The registration in the Israeli "AMAR" of the MOH requires a pre-approval certificate (CE, FDA, Health Canada).
If the Notified Body you are using is recognized by the EU authorities and you hold a valid CE certificate- you should be able to register your product in Israel. You will need to have a local license holder and a distributer.
Yes, you will need to provide a sales history.
Please do not hesitate to contact me with any questions regarding the registration in Israel.
 

RA_QA_Expert

Involved In Discussions
#4
The registration in the Israeli "AMAR" of the MOH requires a pre-approval certificate (CE, FDA, Health Canada).
If the Notified Body you are using is recognized by the EU authorities and you hold a valid CE certificate- you should be able to register your product in Israel. You will need to have a local license holder and a distributer.
Yes, you will need to provide a sales history.
Please do not hesitate to contact me with any questions regarding the registration in Israel.
Unfortunately, I have similar experience like Yujin. Israeli AMAR does not accept any EC certificate from non-western body...
We got approval based on approvals from Health Canada and FDA, although we had valid EC certificate
 
#5
The registration in the Israeli "AMAR" of the MOH requires a pre-approval certificate (CE, FDA, Health Canada).
If the Notified Body you are using is recognized by the EU authorities and you hold a valid CE certificate- you should be able to register your product in Israel. You will need to have a local license holder and a distributer.
Yes, you will need to provide a sales history.
Please do not hesitate to contact me with any questions regarding the registration in Israel.
Hi Mikilk
Thank you for your reply!

My main concern is the possibility of the medical device registration even though my NB is located in Turkey.

Also, if the sales history in recognized country is mandatory, I would like to know the minimum sales volume of it.

You also can send your answer to my personal email. ([email protected])
 
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