M
Mondo 22
I thought this was the case, I wanted to raise this as this could put a stop to any potential registration activities in Iran
Export of Medical Devices to Iran - Medical Device Regulations in Iran
- Thread starter chris1price
- Start date
K
kelvarnson
Re: Export of Medical Devices to Iran
Hello AOIRA,
I was happy to find some information on exporting medical devices and ECCN/EAR99 while doing a Google search and found your helpful post...especially since I have been trying to find out what our medical device ECCN number would be through reading through BIS web site, the CCL list, etc. etc. I am quite confused! I did notice that within a help document I found on the BIS web site, that the first step is to make sure your item is subject to the jurisdiction of the US Dept of Commerce...and since the item I am exporting is a medical device, that falls under FDA's jurisdiction (and since it is a legally marketed device, no FDA approval is needed to export). I was hoping that was my answer and I was done - no requiremnet for ECCN...But, I did see your post mentioning that all medical devices are EAR99... is that because you wanted to export to Iran and due to security issues, the ECCN is required (different rules with embargoed countries)? I do not know what countries we would like to export to at this moment, I just need to establish if I need an ECCN number so that we are ready to go when the need arises. Would you recommend that I register using SNAP-R and go that route - letting BIS assign EAR99 and having an official classification that way? Sorry for such a long note - it seems the more I research the more confused I become with this!
Thank you in advance for any help that you can provide! I appreciate it!
Hello AOIRA,
I was happy to find some information on exporting medical devices and ECCN/EAR99 while doing a Google search and found your helpful post...especially since I have been trying to find out what our medical device ECCN number would be through reading through BIS web site, the CCL list, etc. etc. I am quite confused! I did notice that within a help document I found on the BIS web site, that the first step is to make sure your item is subject to the jurisdiction of the US Dept of Commerce...and since the item I am exporting is a medical device, that falls under FDA's jurisdiction (and since it is a legally marketed device, no FDA approval is needed to export). I was hoping that was my answer and I was done - no requiremnet for ECCN...But, I did see your post mentioning that all medical devices are EAR99... is that because you wanted to export to Iran and due to security issues, the ECCN is required (different rules with embargoed countries)? I do not know what countries we would like to export to at this moment, I just need to establish if I need an ECCN number so that we are ready to go when the need arises. Would you recommend that I register using SNAP-R and go that route - letting BIS assign EAR99 and having an official classification that way? Sorry for such a long note - it seems the more I research the more confused I become with this!
Thank you in advance for any help that you can provide! I appreciate it!
A
AOIRA
Yes, I recommend you apply for an ECCN for each device you plan on exporting so that you are ready to go when the need arises. Things have changed since I did it a few years ago, so just start at the BIS website, Export Control Basics (Exporting 101).
Regards,
David
Regards,
David
K
kelvarnson
Thank you so much for your rapid reply and for your advice.
T
TrickyRicky
Can anyone help? Do you need CE marking on the devices to get approval in IRAN? We will not continue to have the CE mark beginning from next year due to the third edition of 60601-1 (the part 2 standard will probably apply beginning next year).
Will that cause any problem if we do not have the CE marking on the device anymore?
Thanks and kind regards, Ricky
Will that cause any problem if we do not have the CE marking on the device anymore?
Thanks and kind regards, Ricky
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