In order to market medical equipment in Israel, the equipment must be registered with the Department of Medical Devices at the Ministry of Health. This procedure is complex and requires close professional assistance. The Registration of Medical Devices requires periodical renewal, according to the guidelines of the Ministry of Health.
Click Here to determine whether a particular product / device requires Registration of Medical Devices.
The registration procedure includes the collection of numerous documents of the manufacturer and the importer and submitting them to the Department of Medical Devices. Sometimes the Ministry of Health will ask for supplementary material, including manufacturer's quality certificates for each product batch, test certificates from certification institutes / certification bodies, various business data and complementary data for the classification of the medical product. Only after careful examination, the long-awaited Medical Devices Approval will be issued.
The application process for Registration of Medical Devices requires professional skill and a thorough knowledge of the procedures and regulatory processes, in order to complete them efficiently and in as short a time as possible. The procedures are meticulous and consist of strict regulation including dozens of clauses, each of which can stop the entire process and delay product marketing, in case something was not done according to the requirements of the Ministry of Health for registration of medical devices.
After receiving the Medical Devices Approval from the Ministry of Health, the medical equipment can be marketed among the target audience defined in the Medical Devices Approval and according to its detailed instructions.
The SYNCProject's regulation team has gained extensive experience in the registration processes of medical equipment, while assisting dozens of organizations with the Registration of Medical Devices at the Ministry of Health. We have the knowledge and the experience to lead the registration process in a simple and fast manner, so you can start the marking of the medical equipment or product as soon as possible.
Information about registration of medical devices at the Ministry of Health
In order to obtain approval for the import and sale of medical equipment, Registration of Medical Devices is required.
The Department of Medical Devices is part of the Ministry of Health and is responsible for granting import and sale permits for medical equipment in Israel.
The Ministry of Health defines medical equipment as "device, accessory, software, chemical substance, biological or biotechnological product, used for treatment, or required for the operation of an instrument or accessory used for treatment, and that is not intended primarily to act on the human body as a medicinal device".
Products qualified under the definition of medical device are among others, dialysis concentrates, lubricating preparations and various gels designated for the operation of medical equipment, various types of washing solutions, alcohol-soaked dressing materials, and more.
* The national expenditure on health in Israel increased by 4.1% in the previous year, compared to a year earlier and amounted to 77 billion NIS - about 7.5 percent of GDP.
A significant part of the budget was invested in medical devices and equipment.