The Medical Device Division is also the unit concerned with the licensing and supervision process for all kinds of medical devices, including those for rehabilitation, implants, measuring and monitoring devices, drug injection devices, software, cellular apps, mobility devices and combination products (per the second amendment of the medical devices law). The Medical Device Division (“AMAR”) deals with everything from granting permission for registration in the registry of medical devices, to issuing export permits to local manufacturers and import permits to importers of foreign-manufactured medical devices.
Israel does not have its own medical device classification system, but recognizes the classifications from the following authorities, upon submission by the sponsoring company of documented evidence of approval from one of the GHTF countries:
- US FDA 510(k) clearance or PMA approval
- CE mark certificate issued by a European Notified Body
- Certificate to Foreign Governments (CFG) or Certificate of Free Sale (CFS) from the country of origin.
For companies that have already obtained approval for their medical devices in one of these markets (particularly Europe and the US), registration is relatively “straightforward”.
If the device is not registered in one of the GHTF countries, you will need to submit the following documents to the “AMAR” Division:
- Risk Analysis
- Clinical evaluation
- Clinical trial data
- Expert opinion