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Unlocking the Israeli MedTech Market: Pure Global's Expert Guide to AMAR Medical Device Law and Strategic Registration Requirements for MENA Expansion
In this episode of MENA MedTech Insights, we demystify the process of registering medical devices in Israel. We explore the strategic advantages of the AMAR Medical Device Law of 2012, which leverages prior approvals from recognized countries like the U.S. and the E.U. to create a streamlined market-entry pathway.
This episode breaks down the essential, non-negotiable role of the Israel Registration Holder (IRH). We explain why foreign manufacturers cannot go it alone and how a local expert is the key to unlocking this lucrative market. We also touch upon recent 2024 updates that further expedite registration for lower-risk devices, making it more important than ever to have a clear and informed strategy.
A specific example discussed is a U.S. startup with an FDA-cleared diagnostic device. They mistakenly believed their FDA approval granted them direct access, leading to months of delays and frustration trying to navigate the system alone. The pain point was the hidden complexity of local requirements, and the solution was partnering with an IRH who transformed their failed attempts into a successful market launch within weeks.
What You'll Learn:
1. What is the core principle behind Israel’s AMAR registration system?
2. How does approval in a "recognized country" dramatically accelerate your market access?
3. Why is it impossible for a foreign company to register a medical device in Israel without a local partner?
4. What is an Israel Registration Holder (IRH) and what are their key responsibilities?
5. What crucial documents are required for a successful AMAR submission?
6. Are there specific labeling and language requirements for devices sold in Israel?
7. How have recent 2024 changes affected the registration process for low and moderate-risk devices?
8. What common mistakes do companies make when trying to enter the Israeli market?
At Pure Global, we act as your local Israel Registration Holder, providing the in-country expertise required to navigate AMAR regulations. Our end-to-end regulatory solutions, powered by local experts and advanced AI tools, ensure your MedTech and IVD products achieve efficient and compliant market access in Israel and over 30 other countries. To start your journey, contact us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenIn this episode of MENA MedTech Insights, we demystify the process of registering medical devices in Israel. We explore the strategic advantages of the AMAR Medical Device Law of 2012, which leverages prior approvals from recognized countries like the U.S. and the E.U. to create a streamlined market-entry pathway.
This episode breaks down the essential, non-negotiable role of the Israel Registration Holder (IRH). We explain why foreign manufacturers cannot go it alone and how a local expert is the key to unlocking this lucrative market. We also touch upon recent 2024 updates that further expedite registration for lower-risk devices, making it more important than ever to have a clear and informed strategy.
A specific example discussed is a U.S. startup with an FDA-cleared diagnostic device. They mistakenly believed their FDA approval granted them direct access, leading to months of delays and frustration trying to navigate the system alone. The pain point was the hidden complexity of local requirements, and the solution was partnering with an IRH who transformed their failed attempts into a successful market launch within weeks.
What You'll Learn:
1. What is the core principle behind Israel’s AMAR registration system?
2. How does approval in a "recognized country" dramatically accelerate your market access?
3. Why is it impossible for a foreign company to register a medical device in Israel without a local partner?
4. What is an Israel Registration Holder (IRH) and what are their key responsibilities?
5. What crucial documents are required for a successful AMAR submission?
6. Are there specific labeling and language requirements for devices sold in Israel?
7. How have recent 2024 changes affected the registration process for low and moderate-risk devices?
8. What common mistakes do companies make when trying to enter the Israeli market?
At Pure Global, we act as your local Israel Registration Holder, providing the in-country expertise required to navigate AMAR regulations. Our end-to-end regulatory solutions, powered by local experts and advanced AI tools, ensure your MedTech and IVD products achieve efficient and compliant market access in Israel and over 30 other countries. To start your journey, contact us at [email protected] or visit https://pureglobal.com/.