Post Market Surveillance Requirements in Israel

[tehuff]

Hi Covers,
Looking for the requirements for post-market surveillance/complaint reporting (eg. vigilance reporting) in Israel. Does anyone know what is required? We have had an adverse event that occurred in Israel and involved our product. Thanks!

 

[Stijloor]

Hi Covers,
Looking for the requirements for post-market surveillance/complaint reporting (eg. vigilance reporting) in Israel. Does anyone know what is required? We have had an adverse event that occurred in Israel and involved our product. Thanks!

Can someone offer some help?

Thank you!

Stijloor.

 

[Ronen E]

Hi Covers,
Looking for the requirements for post-market surveillance/complaint reporting (eg. vigilance reporting) in Israel. Does anyone know what is required? We have had an adverse event that occurred in Israel and involved our product. Thanks!

Hi,

[I am assuming your product is a medical device; not a drug, biologic etc.]

As much as it would sound strange, Israel still doesn't have an established comprehensive legislation covering the control over medical devices marketing / usage (some specific types are covered under specific laws, though). Such legislation is in the making since 2007 and might be entering its final stages in 2011.

The following is a free (unofficial ) translation from a background document prepared as part of this legislative process:

"...To date Israeli legislation does not include a comprehensive arrangement for the supervision over medical equipment. Existing legislation does not require meeting any terms to allow usage of medical equipment, and does not define a post-marketing control mechanism. The state ministry of health does not have legal authority to require information regarding medical equipment marketed in Israel, or ascertain its compliance with safety and quality standards. The current bill aims to establish supervision over medical equipment, and registration as a prerequisite for usage..."

[The term used is "medical equipment" but the broader context clarifies that it actually refers to "medical devices"]

The ministry of health has some policies and administrative instruments in place, that allow some de-facto control, and the mainstream hospital purchasing establishment complies and cooperates to a significant extent; This may sometimes create the impression that medical devices are regulated in Israel similar to the USA and/or the EC. However, the plain truth is that it may currently be legal to market a medical device in Israel without meeting any commonplace regulatory requirements such as registration/listing of devices, adverse event reporting etc.

In case your product is registered with the Israeli ministry of health, the following may serve as a baseline for reporting adverse events:

The Israeli Ministry of Health, Medical Devices Unit, requires reporting any malfunction or adverse reaction pertaining to the use of the device, which is brought to the company’s attention (within 48 hours). For this purpose, “malfunction” is an incident which caused or could have caused death, life threat, or a need for hospitalization (beyond normal hospitalization that is required for the regular use of the relevant device).

Any such report shall contain the following details:
Device name
Manufacturer’s name
Israeli registration number
Event date
Detailed event description
Report date
Reporting individual’s details: full name, position, signature and phone & fax numbers.

I hope it helps to an extent.

Cheers,
Ronen.

 

[tehuff]

....In case your product is registered with the Israeli ministry of health, the following may serve as a baseline for reporting adverse events:

The Israeli Ministry of Health, Medical Devices Unit, requires reporting any malfunction or adverse reaction pertaining to the use of the device, which is brought to the company’s attention (within 48 hours). For this purpose, “malfunction” is an incident which caused or could have caused death, life threat, or a need for hospitalization (beyond normal hospitalization that is required for the regular use of the relevant device).

Any such report shall contain the following details:
Device name
Manufacturer’s name
Israeli registration number
Event date
Detailed event description
Report date
Reporting individual’s details: full name, position, signature and phone & fax numbers.

I hope it helps to an extent.

Cheers,
Ronen.

Thanks, Ronen! Yes, it is a medical device and yes, it is registered with the Israeli Ministry of Health. Can I ask where you found the adverse event info listed above? On a website? It was very helpful

 

[Ronen E]

Thanks, Ronen! Yes, it is a medical device and yes, it is registered with the Israeli Ministry of Health. Can I ask where you found the adverse event info listed above? On a website? It was very helpful

You're welcome.

It's in an oldish document I have - I think I downloaded it from the Israeli ministry of health website a couple of years ago, but I'm not sure. Anyway, it's in Hebrew...

Cheers,
Ronen.

 

[yana prus]

Can I ask where you found the adverse event info listed above? On a website?

During the initial registration of the medical device in Israel, the foreign manufacturer has to provide a signed statement of commitment to notify Israeli Ministry of Health of MDR to its device.
www.health.gov.il/units/pharmacy/5227/amar.rtf (scroll down to the 6 page - it's in English). The reportable adverse event in Israel is defined as event that led or might lead to death, risk to patient life, prolonged hospitalization.

 

[Ronen E]

During the initial registration of the medical device in Israel, the foreign manufacturer has to provide a signed statement of commitment to notify Israeli Ministry of Health of MDR to its device.
www.health.gov.il/units/pharmacy/5227/amar.rtf (scroll down to the 6 page - it's in English). The reportable adverse event in Israel is defined as event that led or might lead to death, risk to patient life, prolonged hospitalization.

Link seems to be broken.

 

[Dwiggs]

This is a very interesting discussion.

A consultant in Israel recently informed me that our company needed to maintain an authorized representative (similar to EU) for our registered medical devices. Can you confirm that this is not yet a requirement?

Thanks,

 

[Ronen E]

This is a very interesting discussion.

A consultant in Israel recently informed me that our company needed to maintain an authorized representative (similar to EU) for our registered medical devices. Can you confirm that this is not yet a requirement?

Thanks,

Hi,

The text I posted above still holds as of today:

As much as it would sound strange, Israel still doesn't have an established comprehensive legislation covering the control over medical devices marketing / usage (some specific types are covered under specific laws, though). Such legislation is in the making since 2007 and might be entering its final stages in 2011.

The following is a free (unofficial ) translation from a background document prepared as part of this legislative process:

"...To date Israeli legislation does not include a comprehensive arrangement for the supervision over medical equipment. Existing legislation does not require meeting any terms to allow usage of medical equipment, and does not define a post-marketing control mechanism. The state ministry of health does not have legal authority to require information regarding medical equipment marketed in Israel, or ascertain its compliance with safety and quality standards. The current bill aims to establish supervision over medical equipment, and registration as a prerequisite for usage..."

[The term used is "medical equipment" but the broader context clarifies that it actually refers to "medical devices"]

The ministry of health has some policies and administrative instruments in place, that allow some de-facto control, and the mainstream hospital purchasing establishment complies and cooperates to a significant extent; This may sometimes create the impression that medical devices are regulated in Israel similar to the USA and/or the EC. However, the plain truth is that it may currently be legal to market a medical device in Israel without meeting any commonplace regulatory requirements such as registration/listing of devices, adverse event reporting etc.

The bill I mentioned above is still in the legislative process. A worked draft exists and is almost finalised. Last version - not finalised - was circulated for review on 12.3.12. An open-to-public meeting of the parliamentary sub-committee was planned on 13.3.12 to further discuss issues still open. I haven't yet got any updates on the outcomes of that last meeting. As far as I understand the bill is going to begin its voting process sometime quite soon, and 2012 could possibly see Israel's new Medical Equipment Act.

Until then, take every "requirement" coming from that direction, claiming to be "prescribed by law / regulation", with a pinch of salt. There might be a real core (an administrative or other provision applicable in a specific setting), but you'd probably have to enquire a bit to understand whether that is actually the case, and where the requirement is coming from.

Cheers,
Ronen.

 

[Anula]

Hello Ronen
Your posts are very interesting. I have found the Medical Equipment Act that was voted in May 2013. Are you aware of any regulations related to it? I know that MoH issued guidelines for registration submission but are you aware of anything regarding adverse events reporting?