The new Israeli Medical Device Law - Major Points- Taken from Medical Device Law 5772-2012
A Medical Device will be registered in Israel by an Israeli citizen or by a corporation registered in Israel- Israeli Registration Holder.
The validity of the registration in the Register will be determined according to various Registration Periods of the approvals – CE , ISO13485, FDA 510K etc..
Renewal of Medical Devices in Israel- An application will be submitted in the Register at least 4 months prior to the expiry of the existing Amar- approval. If the dossier has been submitted, the registration shall be considered to have been extended until MOH decision regarding the renewal.
Registration in Israel- can be done only for 1 family of products per dossier , with same risk class. .
The registration is acc. to the EU Directive and /or the FDA , Canada , Australia , actually according to the relevant recognized countries by MOH.
Distributors - at least ISO 9001
Up to 3 manufacturing sites per dossier
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