In today’s marketplace, registering medical and in vitro diagnostic (IVD) devices can be an extremely complex and expensive process. If you want to avoid delays to your product launch as well as unnecessary costs, it is crucial to get your license applications right first time. And to do so, you must fully understand the regulatory landscape of each market in which you hope to sell your product.
As the countdown to MEDinISRAEL is now on, we thought we’d provide you with details you should be aware of if you’re planning to launch your product in Israel.
What is the name of the competent authority?
Ministry of Health (Medical Device Department)
What is the competent authority responsible for?
Initially established as the Medical Device Unit in 1993, the Medical Device Department maintains a registration, supervision and control system over the manufacture, import and marketing of medical devices. It is active in various professional frameworks within the Ministry of Health (including the special medical equipment forum and committees for the inclusion of medical devices in the health basket) as well as external frameworks such as the standards committees in the Standards Institution of Israel and inter-ministerial committees in radiation-related fields.
What is the authority’s review timeframe?
120 working days starting from the day the Ministry of Health acknowledges letter of license submission
What is the classification system?
Devices are divided into classes I, II and III.
How long is a license valid for?
It depends on the CE and ISO validity period (the shortest one) and can also be reflected by the ISO validity time of the importer.
Who is the license holder?
The importer for foreign companies, or the manufacturer for domestic companies
A useful thing to know:
Registration of medical devices in Israel is based on approvals in one of the following former GHTF countries: Europe, the United States, Canada, Japan or Australia