Israel's AMAR Regulatory Changes for Medical Devices: A Leap Towards Streamlined Approvals
In September 2023, Israel's regulatory landscape underwent a significant transformation, particularly in the realm of medical devices. The changes introduced by the Israel Ministry of Health (MOH) via the Israel Medical Devices Law, or the AMAR (Access to Medical and Related Devices) system, mark a remarkable shift in the way medical devices are regulated and approved in the country. Among the most notable changes are those affecting the lowest risk classification of medical devices, Risk Class 1, which accounts for a substantial 40% of Israel's medical device registrations. Let's delve into these changes and understand what they mean for the industry.
Simplifying the Regulatory Process AMAR
Traditionally, medical device manufacturers faced a complex and often lengthy regulatory approval process in Israel. The challenge was especially pronounced for low-risk devices, which were subject to the same rigorous scrutiny as higher-risk counterparts. However, the revamped AMAR system has brought about a breath of fresh air by streamlining the regulatory pathway for these devices.
Immediate Registration and Self-Declaration
One of the most significant changes is the introduction of immediate registration and self-declaration for medical devices falling under Risk Class 1. This development means that manufacturers of these devices can expedite the approval process and bring their products to market more swiftly. No longer do they need to navigate an arduous approval journey that may have previously hampered innovation and market access.
Reference Country Authorization
Under the new regulations, medical devices in Risk Class 1 can benefit from reference country authorization. This allows manufacturers to leverage approvals from specified reference countries, making the registration process in Israel considerably more straightforward. The reference countries, as listed in Schedule 1 of the Medical Equipment Law, include Austria, Australia, Italy, Iceland, Ireland, United States, Belgium, United Kingdom, Germany, Denmark, the Netherlands, Greece, Norway, New Zealand, Spain, Portugal, Finland, France, Canada, Sweden, and Switzerland.
Expanded Options for Reference Countries
In practice, the AMAR system has extended its acceptance of reference countries to include Japan and other European Union (EU) member states. This is particularly advantageous for manufacturers with a presence in these countries or those holding CE Marking Certificates issued under the Medical Devices Regulation (2017/745, MDR). By including these additional reference countries, Israel is aligning its regulatory framework with international standards and facilitating smoother market entry for medical device manufacturers.
Impact on the Industry
The changes introduced by Israel's AMAR system are poised to have a profound impact on the medical device industry. Manufacturers can now navigate the regulatory landscape with greater ease, promoting innovation and ensuring that safe and effective devices reach patients more expeditiously. The reduction in bureaucratic hurdles and the expanded list of reference countries will stimulate investment and growth in the Israeli medical device sector, potentially attracting more companies to establish a presence in the region.
Israel's AMAR system has ushered in a new era for the medical device industry, offering a more streamlined and efficient regulatory process, particularly for Risk Class 1 devices. The expansion of reference countries and the introduction of immediate registration/self-declaration provide manufacturers with greater flexibility and opportunities for market access. This regulatory overhaul not only benefits the industry but also ensures that patients have access to innovative, safe, and effective medical devices in a timely manner. Israel's commitment to aligning with international standards positions it as a favorable destination for medical device innovation and development.