Good manufacturing practice (GMP) requirements in the medical industry are designed to ensure that medical devices and medical equipment (abbreviated as "AMAR" in Hebrew) are manufactured in accordance with [...]
A medical device/accessory may be marketed only after having been approved as a medical device and registered in the Medical Devices Department of the Ministry of Health in accordance [...]
Import Importation of medical equipment into Israel through customs requires Ministry of Health approval via a free import order. There are two types of certification issued by the Ministry [...]
Fake or counterfeit medical equipment is equipment that has not been approved by the Ministry of Health and is branded by its manufacturer as original equipment that is recognized [...]
The development of medical equipment can be done in two ways: The first is the fast track route, which refers to the process of developing medical equipment that is [...]
A quality system in the medical field is designed to ensure the safety, efficacy and quality of a consumer medical product and has the aim of protecting public and [...]
Validation is documented proof which provides a high degree of assurance that a system, process, equipment, manufacturing process, and/or medical device software will be properly installed, operated and processed, [...]