Israel Demonstration Medical Device Requirements

B

bender991

Registered
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
 
Ronen E

Ronen E

Problem Solver
Moderator
bender991 said:
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
Click to expand...

Hello Bender and welcome to (posting on) the Cove :bigwave:

There are provisions in the Israeli regulations for usage of devices pending registration. However, the details in your post are not sufficient for providing a definite answer to your questions. For instance:
- What is the device class (in the EU / USA)?
- How exactly is use going to be demonstrated, "non-human"?
- Where / by who (eg a hospital) is it going to be demonstrated?
- How many units are going to be used?

I am referring to:

תקנות ציוד רפואי (ייצור, שיווק או שימוש בציוד רפואי שאינו רשום, או שלא בהתאם לרישומו), התשע"ג – 2013

[Medical equipment regulations (manufacture, marketing or use of unregistered medical equipment, or not according to its registration), 5773 - 2013]

Unfortunately the Israeli regulations are all in Hebrew and I'm not aware of an official English translation.

Cheers,
Ronen.
 
B

bender991

Registered
Hello Rohen,

Thank you kindly for the information. The Hebrew text is helpful, google translate does a good job and I was able to find the document you were referring to.

My apologies for not providing sufficient information. The device is class IIB EU and class III FDA. I got further information from the colleague, demonstration is not the right word, sample might be more appropriate. It is going to be rendered non-usable and presented to doctors for physical purposes only so they are able to feel and hold the device. It will be shown to the doctors by a sales rep. They would like to send two units.

Any further information would be appreciated.

Thank you
 
Ronen E

Ronen E

Problem Solver
Moderator
bender991 said:
Hello Rohen,

Thank you kindly for the information. The Hebrew text is helpful, google translate does a good job and I was able to find the document you were referring to.

My apologies for not providing sufficient information. The device is class IIB EU and class III FDA. I got further information from the colleague, demonstration is not the right word, sample might be more appropriate. It is going to be rendered non-usable and presented to doctors for physical purposes only so they are able to feel and hold the device. It will be shown to the doctors by a sales rep. They would like to send two units.

Any further information would be appreciated.

Thank you
Click to expand...

Hi,

Google Translate is indeed a great tool, especially when you have a short phrase at hand or just want to quickly get your head around something. However, I would take it with a (large) pinch of salt when it comes to translating full texts, especially with regulatory texts where sometimes a single word can make a big difference. Plus, it seldom accounts for cultural context. It would tell you that you're reading the Israeli "Medical Equipment Regulations", But it won't tell you that in the Israeli context this is equivalent to "Medical Devices Regulations". I also use Google translate when I need to understand (high level), for instance, a Chinese regulatory text; but I never fully trust the automatic translation.

In my understanding, presentation of non-usable units to health professionals would not be considerd "use". The regulations I'm aware of are not explicit regarding "promotion of unregistered devices" (which could, technically, also include dissemination of printed matter etc.) - the fact that the presentation will be held by sales reps clarifies that this essentially what the act is.

The regs do speak of unregistered use as part of non-human, non-animal research or of device development, which could have been argued to be the case if the aim was collecting usability feedback / while the device was still being developed. This route involves some formal notification to the authorities, however it seems N/A in your case anyway.

Cheers,
Ronen.
 
shimonv

shimonv

Trusted Information Resource
B

bender991

Registered
Rohen and shimon,

Thank you kindly for the information and link, it is very helpful and greatly appreciated.

Tom
 
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