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 |
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