The dynamic landscape of the medical device industry continues to create avenues for innovation and progress.
As the demand for cutting-edge medical devices, as well as traditional medical devices, surges globally, the Israeli market stands as a beacon of opportunity due to its high growth rate, innovative health system, broad health insurance coverage, accessibility, and high quality of life and life expectancy. However, traversing the regulatory landscape for medical device import, export, and registration in Israel demands in-depth knowledge and meticulous attention.
In this comprehensive guide, we delve into the intricacies of the medical device registration process in Israel, offering insights into export-import dynamics that can be your roadmap to success.
The Israeli Medical Device Regulatory Landscape- A Brief Overview
The Israeli Ministry of Health (IMOH) serves as the guardian of public health and safety, regulating the entry and circulation of medical devices within the country.
The relevant department in the IMOH that deals with medical device submissions, regulation, and post-marketing surveillance is called AMAR.
The IMOH via the AMAR department enables and serves foreign medical device manufacturers eager to tap into the Israeli market, adherence to stringent regulations is not just desirable but imperative.
Medical Device Import to Israel- Navigating the Pathway
Bringing your medical devices to Israel requires a keen understanding of the import process.
Your journey commences with proper risk-based device classification which is usually equivalent to the Europen classification method, which sets the tone for regulatory compliance.
Ensuring your device meets the requisite safety and quality benchmarks is crucial. Equally pivotal is selecting a local importer and registration holder (IRH), the bridge that connects your devices to the Israeli market. Their role encompasses navigating customs, adhering to taxation policies, and securing the necessary approvals as well as post-marketing continuous work in front of the Israeli Ministry of Health (IMOH), to ensure device safety and quality.
Medical Device Export to Israel- Crafting the Strategy
For medical device manufacturers outside Israel seeking to export their medical devices, the country presents a promising destination. However, the journey hinges on understanding the export requirements set forth by the IMOH. Addressing labeling, documentation, and compliance with local standards is pivotal. Collaborating with a reliable, proficient local partner, with no conflict of interest, ensures that your exports align with the specific regulations, smoothing the way for market entry.
Decoding the Medical Device Registration Process
The crux of entering the Israeli market lies in the successful device registration process. First of all, a medical device that is already registered and marketed in GHTF countries such as the European Union, United States, Canada, Australia, and Japan, will have a relatively straightforward and short medical device submission process, but, of course, medical devices from other countries are also acceptable in case the medical device meets the safety and efficacy requirements.
This intricate process entails meticulous documentation, adhering to international standards such as ISO 13485 and ISO 9001, and crafting a thorough technical file.
The IMOH’s review and approval are pivotal junctures that necessitate precision. Working with experienced regulatory experts significantly enhances your chances of seamless registration.
The registration process takes from 3-6 months in case no rejections have occurred.
The Role of the Medical Device Registration Holder (IRH) in Israel
To navigate the complexities of the Israeli regulatory ecosystem, a local registration holder is indispensable. This is a mandatory requirement that is a pre-requisite to the medical device technical file submission to the IMOH.
The local registration older entity acts as your local representative, liaising with the IMOH, handling adverse event reporting, post-marketing surveillance, recalls, receiving and analyzing information from the medical device manufacturer, deviations and non-conformities handling, recalls, and managing compliance issues. Their presence ensures a streamlined communication channel with the regulatory authorities and safeguards your business interests.
For more information about the Israeli Registration Holder (IRH) click here
Your Pathway to Israeli Market Success
The medical device industry thrives on innovation, and the Israeli market eagerly embraces advanced medical and health solutions. Additionally, Israel is considered a well-advanced hub for medical device clinical trials and clinical evaluation and has many public as well as private hospitals with a great emphasis on innovation and research.
As you embark on the journey of importing or exporting medical devices to Israel, partnering with a team versed in the nuances of the regulatory framework is paramount. At Eran Yona.com and Bio-Chem Ltd., we specialize in guiding you through the intricacies of the medical device registration process, ensuring seamless import-export operations, and opening the doors to a thriving market.
Our medical device services and consultancy:
- Medical device Technical file preparation
- Medical device registration/submission in the IMOH
- IRH Services
- Importer and storage services
- Distribution services
You can read more about our medical device registration and import in Israel here.
With an impressive track record spanning 18 years, we’ve empowered countless medical device clients to conquer regulatory challenges, seamlessly navigate imports, and triumph in global markets.
Ready to elevate your journey to success?
Contact us today and let’s unlock new horizons together