Hello all,
A colleague in Israel is requesting a non-sterile unit be shipped for non-human use demonstration purposes. The device is not currently registered in Israel, the registration was submitted and we are expecting approval within 120 days. The device is CE marked and FDA approved.
Does Israel have regulations for medical device demo units? I have concerns a demonstration unit could be considered promotion of an unregistered device. Do special labeling requirements apply for demo units?
Any help would be greatly appreciated. Please provide links to regulations or sources in your response.
Thank you,
-Bender
A colleague in Israel is requesting a non-sterile unit be shipped for non-human use demonstration purposes. The device is not currently registered in Israel, the registration was submitted and we are expecting approval within 120 days. The device is CE marked and FDA approved.
Does Israel have regulations for medical device demo units? I have concerns a demonstration unit could be considered promotion of an unregistered device. Do special labeling requirements apply for demo units?
Any help would be greatly appreciated. Please provide links to regulations or sources in your response.
Thank you,
-Bender