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 following reference markets: Australia, Canada, Europe, or the United States. While Japan is not an officially recognized country by law, a device approved in Japan may also be accepted by AMAR. 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 reference 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)
Additionally, an ISO 13485 Certificate or another recognized Good Manufacturing Practices certification is required.
You must also appoint an in-country 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 validation and certification from the Standards Institution of Israel (SII) in order to support claims of product quality and safety. To obtain SII certification, you may need to submit a sample device along with supporting documentation (such as existing testing reports) 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.