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. T

    U.S. Export of Medical Device to Iran

    Greetings, With the recent U.S. amendment to the Iranian Transactions and Sanctions Regulations (ITSR) relating to the exportation of medical devices to Iran, my company would like to export an IVD product to a customer who contacted us a few weeks ago. Our product does not fall on the...
  3. 3

    Multiple registrations / authorized representatives in Iran

    Hi there, I have a rather common question - this time with regards to Iran: Is it possible to register one medical device multiple times in Iran? I.e. if a local distributor does the registrations and therefore then also holds the registrations, will it be possible to appoint another...
  4. G

    Design Philosophy - Iran Medical Device Registration

    Hello All, I am completing a device registration for Iran and am stuck on one element the "Design Philosophy" The description of this in the registration info seems to be all over the place. Does anyone have an example of what this should look like they would kindly pass along?
  5. B

    Selling Medical devices to Iran - OFAC doubts

    Hi guys. I am looking some information about cost, time and documentation needed to sell medical devices in Iran. We, as european manufacuter, are selling products to the US aswell. So here is where the question comes... A far as I can see, we need to apply for an OFAC license ( TSRA )...
  6. B

    Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt

    Hi, please, I have a doubt about who is the owner of the medical devices's register in the following countries: Iran, India, Jordan, Arab Saudi, Egypt. Our company is not the manufacturer, but we are the marketer of the medical devices. :thanx:
  7. C

    Iran - Who is holder of an Iranian registration in general?

    Hey guys, I need your support. I guess that anyone of you already has gained experience with Iran registrations. Who is holder of an Iranian registration in general? Is it possible and under which circumstances, that the foreign manufacturer (in this case a German manufacturer) holds the...
  8. C

    Medical Device Regulations in Bahrain and Iran

    Is a local representative required to asist with registering devices in the Kingdom of Bahrain and Iran or is it possible for UK companies to deal with the authorities directly? Thanks, Chris
  9. C

    Medical Device Registration Process in Iran

    Dear all, I am seeking medical device registration process in Iran. Thanks in advance to anyone who can help me. Caroline S.
  10. W

    How long is a Medical Device product registration in Iran valid for?

    Does anyone know how long the product registration in Iran is valid for? How often do we have to do renewal? Thanks!
  11. C

    International Training Manager Conference in Iran

    Hi All, I shall be attending this conference organised by Coaching and Training Asia Sdn Bhd located in Malaysia. I was wondering if any Training Managers outthere would like to use Iran as a perfect business opportunity dealing with trainings, this will be the ideal opportunity to invest in...
  12. SteveK

    ?Verification of Conformity (VoC)? ? Experience?

    “Verification of Conformity (VoC)” – Experience? Has anybody any experience with VOCs, specifically exporting/importing medical devices (in our case class IIa mains/battery powered) to Iran? I would appreciate any first hand knowledge of difficulties, problems, best practices, does/don'ts...
  13. chris1price

    Export of Medical Devices to Iran - Medical Device Regulations in Iran

    Hi 1) Does anyone know if there are any specific medical device regulations in Iran? 2) Are there any US or EU requirements for exporting medical devices to Iran? Chris
  14. N

    Iran - Medical Devices Regulations - Homologation

    Dear All, I am in search of information concerning medical devices registration / homologation in Iran. Any support would be great. :thanks: Thanks a lo t in advance & best regards, GB