Regulatory labeling requirements for medical devices are constantly changing, presenting a challenge for manufacturers and distributors who must comply with various country-specific registration requirements.
US Food & Drug Administration (FDA):
High-quality labeling is necessary to ensure device performance as well as patient and user safety. Therefore, the use of FDA-recognized labeling standards is highly recommended and can facilitate your approval/clearance process. FDA labeling requirements can be found in 21 C.F.R. Part 801. You may also refer to ISO 15223-1 and ISO 20417 an international standards recognized by the FDA for the use of symbols on medical device labeling.
Note: The FDA constantly publishes new guidelines to assist companies in better understanding regulatory requirements, so be sure to reference the most current information available.
EU CE Marking:
The CE mark is a specific certification demonstrating that a product meets EU health, safety, and environmental requirements. To apply a CE mark to a medical device, you must demonstrate compliance with the EU Medical Device Directive/Regulation (MDD/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 MDD/MDR requires that labeling be provided in plain language that is clearly comprehensible to the end user. ISO 15223-1 and ISO 20417 may serve as references for labeling requirements.
Israel Guidelines:
To sell a medical device in Israel, you 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. 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.
However, there are 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.
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