Regulatory requirements for the medical devices industry are constantly changing, which can be quite challenging for manufacturers and distributors that need to comply with a variety of country-specific registration requirements.
If you wish to sell a medical device in Israel, you’ll need to demonstrate compliance with the requirements of the Medical Device Division of the Israeli Ministry of Health (AMAR).
Israel does not have its own classification system for medical devices, but it accepts the classification method and the applicable regulatory requirements of the United States, EU, Australia and Canada. As such, products that are FDA approved or EU CE marked should already have the essential parts of the device dossier required to complete the registration process in Israel.
US Food & Drug Administration (FDA)
High quality labeling is necessary to ensure device performance as well as patient and user safety. As such, the use of FDA recognized labeling standards is highly recommended and can facilitate your approval/clearance process. FDA labeling requirements can be found in Title 21 (see Sec. 801.15). You may also refer to ISO 15223-1, an international standard recognized by the FDA for use of symbols on medical device labeling.
Note: The FDA constantly publishes new guidelines which can assist companies to better understand the regulatory requirements, so be sure to reference the most current information available.
EU CE marking
A CE mark is a specific certification demonstrating that a product meets EU health, safety and environmental requirements. In order to apply a CE mark on a medical device, you must demonstrate compliance with the EU Medical Device Regulation (MDR) which defines labels as “written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.” The MDR requires that labeling will be provided in plain language that is clearly comprehensible to the end user.
As stated above, if a product is already in compliance with the FDA or EU MDR then it can be assumed that its labeling covers the regulatory requirements in Israel. Still, there are some specific requirements related to labeling translation in Israel. For example, the Israel Ministry of Health has different translation requirements for devices intended for professional use and devices intended for home use.
In Israel, when the device is intended for professional use in healthcare facilities, the labeling may be provided in English-only. When the device is intended for home use, labeling must be provided in three languages: Hebrew (Israel’s official language), Arabic and English.
The Medical Device Division of the Israeli Ministry of Health (AMAR) is the regulatory authority in Israel for medical devices. In order to register a device in Israel, you must submit a product dossier (including labeling and regulatory approvals from other recognized countries) to AMAR. In Israel, labeling of products for professional use can be provided in English-only, while labeling for home use devices should be provided in at least in 3 languages: Hebrew, Arabic and English.
About the author:
My Name is Dalia Givony and I am a regulatory and clinical affairs consultant with 20 years of experience in global regulatory and clinical studies of medical devices, including 7 years at Medtronic specializing in executive RA & Clinical management. I offer my customers professional support for FDA submissions, CE marking, Global Registration (including registration in Israel), as well as design and management of clinical studies. With proven experience in direct communication and negotiation with the FDA, CE and other regulatory authorities, I aim to reduce the regulatory burden and V&V requirements and specialize in innovative, creative and effective regulatory strategies that take your other business aspects into consideration. Trust me to plan and manage cost-effective pre & post market clinical studies that will support your local regulatory requirements, as well as expansion into new markets. If your company needs regulatory and clinical support in Israel, you are welcome to contact me at [email protected] or visit www.daliag.com