Medical Device Registration and Approval in Israel
Gaining access to the Israeli medical device market—one of the largest in the Middle East—requires registering your device with AMAR, the Israeli Ministry of Health’s medical device regulation unit.
Medical device registration in Israel is based having prior approval in one of the five founding Global Harmonization Task Force (GHTF) countries: Australia, Canada, Europe, Japan, or the United States. Manufacturers that have already obtained approval for their devices in those markets can leverage those registrations to satisfy most of Israel’s medical device regulatory approval requirements.
Required Documents for Medical Device Registration in Israel
Israel’s AMAR regulators require documents to demonstrate approval in the GHTF countries, such as:
- FDA 510(k) or premarket approval letter
- CE Marking certificate issued by a European Notified Body
- Certificate to Foreign Government (CFG) or Certificate of Free Sale (CFS)
- Proof of ISO 13485 certification
You must also appoint an authorized representative in Israel to interact with AMAR on your behalf and manage your application process.
Additional Requirements for Obtaining Medical Device Approval in Israel
Certain electro-medical devices also require Israel Standard Institute (ISI) validation and certification in order to ensure product quality and safety. To obtain ISI certification, you may need to submit a sample device along with supporting documentation (such as existing testing reports) to the ISI for evaluation.
Getting your device listed on Israel’s four major Sick Funds (health insurance entities) is also necessary in order for Israeli hospitals and health care providers to order your products. As part of the listing process, a Sick Fund may request a device sample from you and possibly require product testing within Israel.
Through our office in Israel, Emergo can assist you with determining the registration requirements for your medical device and obtaining approval from AMAR.