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Israel's Gatekeeper: Mastering the Role of the IRH for MedTech Success
Navigating the Israeli medical device market requires a deep understanding of its unique regulatory landscape. This episode provides a comprehensive overview of the Israel Registration Holder (IRH), a mandatory in-country representative for foreign manufacturers. We explore the IRH's crucial role in liaising with the AMAR (Ministry of Health), their extensive responsibilities from registration to post-market surveillance, and the strategic advantages of appointing an independent holder over a distributor. We also touch on the 2024 regulatory reforms that have streamlined market access. • What…
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