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
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