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.
Recognized countries by MOH Israel for registration in Israel are as follows:
Austria, Australia , Italy ,Island ,Ireland, USA, Belgium, UK, Germany, Denmark, Holland ,Greece, Norway, New Zealand, Spain ,Portugal, Finland, France, Canada, Sweden, Switzerland
Manufacturers - need ISO 13485 and CE for class I sterile, Im ,IIa, IIB,III devices
Distributors - at least ISO 9001
Up to 3 manufacturing sites per dossier
Separation of :
- Sterile and not sterile products will be registered separately
- implants , unless they are included in 1 system
- Different Classes – Risk levels of products , unless various classes are 1 system +accessories
- Biological and non biological products
- OTC & Professional Devices
Registration procedure in Israel takes -minimum / approx. 120 Days
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