The Ministry of Health has published a series of changes in medical equipment imports to Israel. The main changes will shorten registration times for most medical equipment already approved for sale overseas. The Ministry of Health and its Department of Medical Device (MDM) will focus on registration, regulation, and licensing of new equipment, to encourage the registration of medical equipment developed by Israelis, with the Ministry of Health as the primary regulator, thus encouraging R&D innovation in Israel.
This is the third significant step announced by the Ministry of Health this month, in addition to significant changes in cannabis and food import regulation. Here too, the approach is to lower regulatory barriers and transfer responsibility to the companies as much as possible.
In Israel’s biomed sector, there were calls for similar treatment for medical equipment, and generic and innovative drugs, seeking similar registration procedures based on Declarations of Foreign Manufacture for products already approved for marketing by respected regulatory authorities such as the Food and Drug Administration (FDA) in the US or the European Medicines Agency. For the time being, the change only applies to medical equipment.
Products will be divided into categories. Category 1 products can now be marketed in Israel with only a Declaration of Foreign Manufacture. Among these are wheelchairs, rehabilitation equipment, medical pads, and syringes. These products make up about 40% of all the medical equipment registered and marketed in Israel.
Category 2 comprises low-to-medium risk products. These will be registered partly on the basis of a Declaration, and partly through a shortened 60-day licensing procedure, provided they are registered with the FDA and marketed in the US. They are mainly minimally invasive, not implantable products.
Category 3 products are those defined as high-risk, for example stents or other implants. These will be approved using the same procedure that has been in effect until now.
Changes to a product will automatically be accepted in the Declaration after having received approval in Europe and the US, unless the changes are material. The question of what constitutes a material change will be determined in accordance with EU Medical Device Regulation (MDR) guidance.
Implementation of these new criteria is dependent on processes at the Ministry of Health, such as a computer system upgrade, and outsourcing of services to provide a comprehensive solution for the registration procedure and a marketing monitoring mechanism that will include supervision and enforcement.
About NIS 90 million in savings
The Ministry of Health estimates that, as a result of these changes, prices of medical equipment will decrease and save Israel’s economy approximately NIS 90 million, and that the entry of the new devices into Israel will be faster. Israel’s medical equipment market is estimated at approximately NIS 9 billion per year, and the estimate of savings assumes that regulatory expenses constitute approximately 5% of total costs, and that the changes will offer a saving of 20% on these expenses.
Minister of Health Moshe Arbel said: "The MDM reform will facilitate the import of medical equipment, help increase supply for consumers, and lower costs. The Ministry of Health will continue to work to reduce regulation in every area where it is possible to do so."
Published by Globes, Israel business news - en.globes.co.il - on August 21, 2023.
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