Israel Medical Device Regulations

Agency

All medical devices are regulated by the Ministry of Health Medical Institutions and Devices Licensing Department (known as AMAR)

Medical Device Definition

Medical equipment - each described below, and except as defined in the preparation Pharmacists [New Version], 1981; (1) Device used for medical treatment, as well as a device or computer program needed to run such an instrument; In this regard, "device" - including accessory, chemical, or biological product biotechnological product; (2) Contact lenses; (3) The electrical device that emits ionizing or nonionizing radiation is used Cosmetic treatment

Classification of Medical Device

No classification system for medical devices in Israel

Premarket Approval Process

Prepare application dossier. This includes: FDA 510(k), CE Marking Certificate, or regulatory approval from Australia, Canada, or Japan; Certificate to Foreign Government (CFG) or Certificate of Free Sale (CFS); and Proof of ISO 13485 certification.

If not registered in "recognized country*:" risk analysis, clinical evaluation, clinical trial information, and expert opinions required.

Appoint Israel registrant to manage application process.

Electromedical devices: require Israel Standard Institute (ISI) validation and certification. In order to get ISI validation a sample must be submitted along with testing report documentation

Enter Sick Fund listing process to ensure that device can be ordered by hospitals and healthcare providers (Fund may request device sample and require local product testing).

Postmarket Regulations

Postmarketing reports are required upon request Must report adverse events from device (eIther in Israel or in other countries) Must report restrictions from other regulatory bodies concerning the registered device

Notes

.A "recognized country" is defined in section 1 of the Medical Devices Law as one of the countries listed in the First Annex, including the US. Medical Devices Law, 5772-2012
Registration valid for five years
"Official" timeframe for registration is 120 days. Registration may take up to 9 months due to authorities requesting additional documents

Source: WHO, AMAR

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