{"id":3419,"date":"2025-02-05T22:14:54","date_gmt":"2025-02-05T19:14:54","guid":{"rendered":"https:\/\/galiamir.com\/?p=3419"},"modified":"2025-03-23T16:12:58","modified_gmt":"2025-03-23T13:12:58","slug":"medical-device-registration","status":"publish","type":"post","link":"https:\/\/galiamir.com\/en\/medical-device-registration\/","title":{"rendered":"Medical Device Registration in Israel: Essential Guide to Licenses and Renewals"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">When it comes to <\/span><span style=\"font-weight: 400;\">medical device registration in Israel<\/span><span style=\"font-weight: 400;\">, understanding the different pathways for registering and renewing medical devices is crucial for compliance and continued market access. The blog highlights the existing registration pathways in the medical equipment registry.<\/span><\/p>\n<h2><b>1. <\/b><b>License Renewals of Medical Devices in Israel<\/b><span style=\"font-weight: 400;\"> &#8211; By Declaration\u00a0<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">This registration pathway is designed for low-risk medical devices (Class I) and low-risk in vitro diagnostic (IVD) devices. Here are the key details of <\/span><b>medical devices license renewal<\/b><span style=\"font-weight: 400;\"> and registration:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registration is carried out based on the registrant&#8217;s declaration.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The pathway applies to medical equipment registered and marketed only in recognised countries.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">This process is independent and immediate, done through the vault, following the instructions on the website.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Applications can be submitted starting October 1st of each calendar year for the following year. For example, an application submitted on 1.10.2024 will be valid until 31.12.2025.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2><b>2. Fast-Track <\/b><b>Medical Devices License Renewal<\/b><b> &amp; Registration Process<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">The fast-track registration process applies to medium-risk medical devices (Class II) and medium-risk in vitro diagnostic (IVD) devices. Key features of this <\/span><b>medical device registration in Israel<\/b><span style=\"font-weight: 400;\"> pathway include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">This process is only available for devices registered and marketed in recognized countries.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Processing times for requests on this track are shorter than on the regular track.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Requests submitted via the regular track may be transferred to the expedited track, following the guidelines outlined in the procedure of registration and <\/span><b>license renewals of medical devices in Israel<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<\/ul>\n<h2><b>3. Regular <\/b><b>Medical Devices License Registration<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">This pathway is suitable for high-risk medical devices (Class II and Class III) and laboratory equipment (IVD) with equivalent risk levels. Here\u2019s what you need to know:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">This process applies to both medical devices manufactured in Israel and those that are not marketed in recognized countries.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It is also relevant for <\/span><b>medical devices license registration<\/b><span style=\"font-weight: 400;\"> for products with higher risk levels.<\/span><\/li>\n<\/ul>\n<h2><b>Not sure where to start? That\u2019s exactly where we come in!<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">We are here to help you complete the <\/span><b>medical devices license registration<\/b><span style=\"font-weight: 400;\"> process smoothly, quickly, and accurately.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Don&#8217;t wait until the last minute!<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Contact us today, and we will accompany you through the registration or renewal process, so you can continue to operate with peace of mind, knowing that everything is in order.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Contact us now, and let&#8217;s start working together!<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">For questions or additional details on <\/span><b>Medical<\/b> <b>Device<\/b> <b>Registration<\/b> <b>in<\/b> <b>Israel<\/b> <span style=\"font-weight: 400;\">\u2013 we are here for you.<\/span><\/p>\n<h3><a href=\"https:\/\/galiamir.com\/en\/contact\/\">\ud83d\udce9 Contact Us Today!<\/a><\/h3>\n","protected":false},"excerpt":{"rendered":"<p>Whether you&#8217;re renewing a Class I device or registering a high-risk product, understanding the right pathway is key. This guide breaks down Israel\u2019s three main registration tracks-by declaration, fast-track, and regular-so you can stay compliant and on the market.<\/p>\n","protected":false},"author":1,"featured_media":3659,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[28,29],"class_list":["post-3419","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices","tag-license-renewals-of-medical-devices-in-israel","tag-medical-devices-license-renewal"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Registration in Israel: Essential Guide to Licenses and Renewals - Gali Regulatory Services<\/title>\n<meta name=\"description\" content=\"Explore the essential guide to medical device registration in Israel, including license renewals by declaration, fast-track, and regular pathways. 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