Explore the medical device requirements currently available for Israel, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Route Dependent
AMAR approvals have explicit expiry dates and are renewed; duration can track the underlying reference approval and route rather than one universal term.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Expired approval cannot support ordinary continued marketing absent an official extension.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Renew before expiry with current foreign regulatory evidence and importer/manufacturer declarations.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Official fee categories confirm changes to indication, device/manufacturer name and foreign manufacturer's representative.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Licensed Importer As Applicant
Israeli importer/AMAR registration holder
yes
Submits And Holds Local Registration
Usually Same
May Be Same Or Downstream
allowed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Registration Change For Importer Or Foreign Representative
Route Dependent
Exact transfer sequence is not yet exposed as a current English service.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
