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 requestMust 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