In a groundbreaking move, the Ministry of Health (IMOH) introduced the Medical Equipment Reform in its AMAR division.
This new reform for medical devices redefines the landscape of medical device registration in Israel and medical device importing/exporting to the Israeli market.
This bold reform is a resolute step towards slashing bureaucratic complexities and ushering in a regulatory environment primed for growth.
What is the AMAR division in the IMOH
In the realm of medical device operations, Israel’s focal regulatory entity is the Medical Device Division of the Ministry of Health, famously known as “AMAR.” This division holds the reins of medical device registration, submissions, oversight, and meticulous control spanning manufacturing, assembly, sterilization, importation, and marketing within the State of Israel.
At its core, AMAR orchestrates diverse import permits for medical devices, vigilantly monitoring every facet of the marketing journey. This body is equally renowned for its role in disseminating crucial documents, guidelines, and procedures. These resources serve as beacons of guidance for the import process of medical devices crafted abroad and destined for Israel’s market.
New regulations for medical device registration and import to Israel
In the realm of medical device operations, Israel’s focal regulatory entity is the Medical Device Division of the Ministry of Health, famously known as “AMAR.” This division holds the reins of medical device registration, submissions, oversight, and meticulous control spanning manufacturing, assembly, sterilization, importation, and marketing within the State of Israel.
At its core, AMAR orchestrates diverse import permits for medical devices, vigilantly monitoring every facet of the marketing journey. This body is equally renowned for its role in disseminating crucial documents, guidelines, and procedures. These resources serve as beacons of guidance for the import process of medical devices crafted abroad and destined for Israel’s market.
At the heart of this paradigm shift lies a monumental reduction in medical device registration timelines, poised to revolutionize the import and export landscape.
Underpinned by a risk-based classification system, the IOMH reform presents an innovative avenue for swift approvals.
Below are the main changes per medical device classification:
| Medical device class | New regulatory requirements |
| I | Low-risk medical devices will now be granted immediate approval via a self-declaration process |
| II | For devices with moderate risk, a rapid 60-day accelerated track awaits, contingent upon registration and recognition by acknowledged nations like the USA and Europe |
| III | Will remain unchanged in the registration process—for example, stents for arteries and the like. |
| Renewals | For all types of medical equipment and devices, it will be possible to renew the notification based on the countries of Europe and the USA. Changes – There will be a distinction between a change that is not essential and a change that is essential through the adoption of the European Union directives (MDR) when a change that is not essential will be recorded in the declaration /notification. For registering a substantial change, an SLA is established. |
How new medical device registration in Israel will look after reform
As the tides of responsibility shift, manufacturers and importers find themselves at the helm of compliance, galvanized by streamlined processes.
The IMOH reform transcends bureaucratic hurdles, paving a direct route to market entry that echoes efficiency, cost-effectiveness, and timely access to groundbreaking medical solutions.
This seismic reform dovetails seamlessly with Israel’s commitment to fostering a competitive market ecosystem.
As the annual medical equipment market nears NIS 9 billion, the projected savings of over NIS 90 million annually heralds an era of affordability and innovation, promising a diverse array of innovative medical devices for Israeli consumers.
Amidst the whirlwind of this transformation, Eran Yona, Bio-Chem Ltd. CEO emerges as your unwavering partner.
With our resolute focus on medical device registration in Israel and facilitating importing/exporting endeavors, we stand poised to guide manufacturers through this regulatory evolution.
Reach out to us today and navigate this transformative era in medical device market entry.
Elevate your brand’s journey with a strategic alliance that champions compliance, efficacy, and unrivaled market success.
