1. F

    Class IIa/b in-country registrations x5 ?

    Hi all. We have two devices that we are wanting to sell within the following 5 countries: South Africa Iran Israel Kuwait UAE One of the devices is Class IIa and the other Class IIb (per the Medical Device Directive). I know some countries within the EU (my main focus) require additional...
  2. P

    Selling Medical Devices from the US into Israel

    Is there any reason a medical device manufacturer located in the US (FDA and ISO 13485) would also need ISO 9001 in order to sell into Israel?
  3. B

    Israel Demonstration Medical Device Requirements

    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...
  4. 3

    Israel: 1 Medical Device, Multiple Registrations = Possible?

    Hi there, Well- I guess, the title says it all: Is it possible to register the same medical device more than once in Israel? (only difference would be the Registration holders) I've heard multiple answers, but none of them was based on any form of evidence (e.g. an official document). Is there...
  5. B

    Israel Medical Device registration

    Hello guys, it is nice to be here. First of all, I am here to help and get some help. I am seeking for the requirements/information to register a MD in Israel, Thanks in advance!
  6. A

    Creating Global Giants from a Culture of Israeli Start-Ups

    Creating Global Giants from a Culture of Israeli Start-Ups
  7. Hershal

    Interesting Israel Holiday

    Just got back from Israel couple of days ago. A short business trip. Right now they are finishing the 2nd day of a Holiday. This Holiday was explained to me, but the short version is a 2-day version of Halloween, but without trick-or-treating. Costumes and partying appear to be the main things...
  8. Z

    Definition of a Medical Device in Israel's Regulations

    Hi! Can anyone help me with this and point out the legal source of the definition of medical device in Israel's regulation? Thanks Zhang
  9. M

    Israeli Labeling Requirements for Medical Devices

    Hello All, I am looking for some help on the labelling requirements for medical devices in Israel. We are a medical device manufacturer based in Ireland. We have a medical device which is Class III in Europe (currently undergoing CE mark review it's a drug device combination because it...
  10. N

    Exporting Class III Medical Devices to Canada from Israel

    Hi, We recently got approval for selling a Class III Medical Device in Canada. I am not sure what all the certificates and documents will be required for exporting our device to Canada from our side i.e. Manufacturer and also from the importer i.e. distributor. Any help on this is highly...
  11. T

    Post Market Surveillance Requirements in Israel

    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!:)
  12. Howard Atkins

    Agassi, Renault Nissan & Israel announce project for oil-independent country - 2008

    Today the government of Israel and Renault-Nissan announced their collaboration along the Better Place framework - creating the first three way partnership for an oil-independent country.