In a groundbreaking development, Israel’s Ministry of Health (IMOH) has initiated a significant shift in its AMAR division, transitioning from traditional medical device registration to encompass the realm of medical software, SaMD (Software as a Medical Device), and IVD (In Vitro Diagnostic) devices, with a strong focus on registration and marketing procedures in Israel.
This pioneering reform marks a decisive departure from the conventional bureaucratic complexities, paving the way for a more streamlined regulatory environment tailored to foster growth and innovation.
The AMAR Division in the Israeli MOH
In the domain of medical software, SaMD, IVD, and other digital health and E-Health services and solutions, Israel’s central regulatory authority is the Medical Device Division within the Ministry of Health, often referred to as “AMAR.”
AMAR plays a pivotal role in overseeing various facets of registration, submissions, and meticulous control across development, integrity, reliability, accuracy, clinical evaluation, quality, information security, marketing, and post-marketing surveillance activities within Israel.
At its core, AMAR orchestrates the issuance of diverse permits for importing medical software, SaMD, and IVD devices, rigorously overseeing every step of its marketing journey.
It is equally renowned for disseminating essential documents, guidelines, and procedures, serving as invaluable resources guiding the import process for such Medical Software, SaMD, and IVD developed abroad and intended for the Israeli market.
New Regulations for Medical Software, SaMD, and IVD Registration and Import in Israel
This transformative reform introduces a remarkable reduction in registration timelines for medical software, SaMD, and IVD devices, promising to revolutionize the landscape of import and marketing activities.
Built upon a risk-based classification system, the IMOH reform introduces an innovative pathway for expedited approvals.
Key changes based on Medical Software, SaMD, and IVD classification in Israel
Just like medical device classification in the FDA and the CE, Medical Software, SaMD, and IVD are classified based on risks:
Class I Medical Software, SaMD, and IVD in Israel
Low-risk Medical Software, SaMD, and IVD will now enjoy immediate approval through a self-declaration process.
Class II Medical Software, SaMD, and IVD in Israel
Medical Software, SaMD, and IVD with moderate risk will follow an accelerated 60-day track, contingent upon registration and recognition by reputable nations like the USA and Europe.
Class III Medical Software, SaMD, and IVD in Israel
Registration procedures for high-risk Medical Software, SaMD, and IVD will remain unchanged.
Software, SaMD, and IVD Registration Renewals in Israel
All types of Medical Software, SaMD, and IVD will have the option to renew notifications based on European and USA regulations.
Additionally, there will be a distinction between non-essential and essential changes, following the adoption of European Union directives (MDR). For substantial changes, a Service Level Agreement (SLA) is established.
The Future of Medical Software, SaMD, and IVD Registration in Israel
This transformative reform in the Israeli Ministry of Health shifts the responsibility for compliance to Medical Software, SaMD, and IVD Developers and importers, offering streamlined processes.
The IMOH reform clears bureaucratic obstacles, creating a direct pathway to market entry marked by efficiency, cost-effectiveness, and timely access to cutting-edge Medical Software, SaMD, and IVD solutions.
This reform aligns seamlessly with Israel’s commitment to nurturing a competitive market ecosystem.
With the annual medical device, Medical Software, SaMD, and IVD market nearing 10 billion NIS per year, the anticipated annual savings of over 100 million NIS signal an era of affordability and innovation, ensuring a diverse range of innovative medical software, SaMD, and IVD devices for Israeli consumers, hospitals and clinics.
Amidst this transformative period, Eran Yona, CEO of Bio-Chem Ltd., emerges as a steadfast partner.
With a steadfast focus on medical software, SaMD, and IVD registration in Israel and facilitating importing/exporting endeavors including a local Registration holder service, we are well-prepared to guide Medical Software, SaMD, and IVD companies through this regulatory evolution.
Contact us today to navigate this transformative era in entering the medical software, SaMD, and IVD device market, and elevate your brand’s journey with a strategic alliance that champions compliance, efficacy, and unparalleled market success.
