The ever-evolving landscape of the digital health and E-Health industry in general and medical software, IVD, and SaMD industry in particular continues to pave the way for innovation and advancement.
As global demand for cutting-edge AI-based medical software, IVD, and SaMD devices surges, the Israeli market emerges as a beacon of opportunity.
The Israeli market is a 10 Billion market and is considered an innovative one, with high accessibility of patients to innovative E-Health services and solutions.
The opportunity to distribute Medical Software, IVD, and SaMD in Israel is attractive due to its impressive growth rate, innovative healthcare system, extensive health insurance coverage, high quality of life, and exceptional life expectancy.
However, successfully navigating the regulatory terrain for the import, export, and registration of Medical Software, IVD, and SaMD in Israel requires a profound understanding and meticulous attention.
In this all-encompassing guide, we delve deep into the intricacies of the registration process for medical software, IVD, and SaMD in Israel, providing valuable insights into the dynamics of the export and distribution of Medical Software, IVD, and SaMD that can serve as your roadmap to success.
An Overview of the Israeli Medical Software, IVD, and SaMD Regulatory Landscape
The safeguarding of public health and safety in Israel falls under the jurisdiction of the AMAR Division of the Israeli Ministry of Health (IMOH), which regulates the entry and circulation of Digital health/E-Health services such as medical software, IVD, and SaMD within the country.
The Israeli AMAR department is responsible for submissions, regulation, and post-marketing surveillance of these E-Health services within the IMOH.
For foreign Digital health/E-Health companies such as medical software, IVD, and SaMD solutions aiming to enter the Israeli market, strict compliance with regulations is not merely desirable but imperative.
Navigating the Path to Importing Medical Software, IVD, and SaMD to Israel
Bringing medical software, IVD, and SaMD services into Israel necessitates a thorough grasp of the importation process.
The journey begins with a meticulous risk-based Digital health services classification, often akin to the European classification method, which sets the foundation for regulatory compliance.
Ensuring that your E-Health service meets the requisite safety and quality standards is of paramount importance.
Equally critical is the selection of a local Importer and Registration Holder (IRH), the crucial link connecting your Medical software to the Israeli market as well as to the IMOH. Their role encompasses navigating customs procedures, adhering to tax policies, securing necessary approvals, and ensuring post-marketing quality, safety, and compliance with the Israeli Ministry of Health (IMOH).
Crafting an Export Strategy for Medical Software, IVD, and SaMD to Israel
For medical software, IVD, and SaMD companies outside of Israel seeking to export their E-Health services, the nation presents an enticing prospect. However, the success of this endeavor hinges on a deep understanding of the export requirements outlined by the IMOH. Addressing labeling, documentation, and compliance with local standards is pivotal.
Collaborating with a dependable, proficient local partner, devoid of conflicts of interest, ensures that your exports align seamlessly with specific regulations, facilitating market entry.
Deciphering the Registration Process for Medical Software, IVD, and SaMD in Israel
The core of entering the Israeli market for medical software, IVD, and SaMD devices lies in a successful registration process.
If a device is already registered and marketed in GHTF countries such as the European Union, the United States, Canada, Australia, and Japan, the submission process tends to be relatively straightforward and swift. Nevertheless, devices from other countries are also accepted, provided they meet safety and efficacy requirements.
This intricate process involves meticulous documentation, adherence to international standards like ISO 13485 and ISO 9001, and the creation of a comprehensive technical file. The IMOH’s review and approval stages are critical junctures requiring precision.
Collaborating with seasoned regulatory experts significantly enhances your chances of a smooth registration process, which typically takes 3-6 months if no rejections occur.
The Role of the Registration Holder (IRH) for Medical Software, IVD, and SaMD in Israel
To navigate the complexities of the Israeli regulatory landscape for medical software, IVD, and SaMD, a local registration holder is indispensable. This is a mandatory requirement preceding the submission of the technical file to the IMOH.
The local registration holder acts as your local representative of the company, liaising with the IMOH in various areas such as:
- Managing adverse event reporting
- Post-marketing surveillance
- Deviations and non-conformities
Although it is mandatory, the registration holder’s presence ensures streamlined communication with regulatory authorities and safeguards your business interests in the Israeli market.
Your Pathway to Success in the Israeli Market for Medical Software, IVD, and SaMD
The Digital health industry in general and medical software, IVD, and AI-based SaMD, in particular, thrive on innovation, and the Israeli market eagerly embraces advanced medical and health solutions. Israel is also recognized as a leading hub for clinical trials and evaluations of these devices, boasting numerous public and private healthcare institutions with a strong focus on innovation and research.
As you embark on the journey of importing or exporting your medical software, IVD, and SaMD to Israel, partnering with a team well-versed in the nuances of the regulatory framework is paramount.
Eran Yona and Bio-Chem Ltd. specialize in guiding you through the intricacies of the registration process for medical software, IVD, and SaMD in Israel, ensuring seamless import-export operations, and opening doors to a thriving market.
Our suite of services includes:
- Technical file preparation
- Registration/submission in the IMOH
- IRH and importing services
- Marketing and networking support
With an impressive track record spanning 18 years, we’ve empowered countless clients in the medical software, IVD, and SaMD industries to overcome regulatory challenges, navigate imports seamlessly, and succeed in global markets.