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

[Rocke]

Re: Export of Medical Devices to Iran

Hi Britta,
I am located in Denmark and recently went through the registration process in Iran.

For the Letter of Authorization I got it signed by the Danish Chamber of Commerce, then the Danish Foreign Ministry and finally by the Iranian Embassy in Denmark. This was accepted by the Iranian MOH without problems.

Please note, that the Iranian Embassy in Denmark requires you to provide 2 document copies in notarized form from the Chamber of Commerce and the Ministry of Foreign Affairs, one original and one copy they retain. I do not know if the same is true in Germany, but it is definitely helpful if you are able to do a phone consult with the embassy concerning their requirements for notarization, before initiating the process.

Good luck,
Camilla

 

[Katze]

Re: Export of Medical Devices to Iran

Hey Rocke,

the thing with the foreign ministry is new to me. The first time I talked to the Iranian Consulate (the time they actually answered the phone...), they didn't mention a legalization by the German forein ministry.
I will call it, maybe they can help me...

Thanks a lot, you guys are really big help!

Regards, Britta

 

[gurumuni - 2010]

Re: Export of Medical Devices to Iran

Hi AOIRA,

The information provided by you is very useful. I am currenly researching on the IRAN regulation for exporting medical devices i.e. registration process to place medical device in the IRan markets and was curious to know what was the outcome of your process. Can you share your experience and further information that will help me understand it better.

 

[AOIRA]

Registering products for sale in Iran and exporting products to Iran are two different things, which I'm sure you already understand.

Exporting - Start at https://www.bis.doc.gov/licensing/exportingbasics.htm and after many months you'll figure out everything and have yourself a license, which is needed to export pretty much everything to Iran, including medical devices (which you will find have the ECCN EAR99). Having a distributor in Iran that already has experience with this can make it a lot easier on you.

Registering - Handled like any emerging market, i.e. they each have their own unique way of doing it. From my experience the customer in Iran provided me with a list and sample of each required document, which I reproduced. Then each document got notarized, certified by the Secretary of State in the state where notarized, certified by the U.S. Secretary of State, then legalized/consularized by the Iran Interest Section of the Pakistan Embassy in Washington, D.C. Of course, I didn't just take the customer's word and also went to the Iran MOH website, and export.gov (medical device regulatory information).

I can't tell you how to do all this step-by-step, for the same reason that you weren't allowed to use a calculator until college

Good luck!

 

[Chinquada]

No matter, where you want to register, there is one good way to find out almost everything.

When you export from EEC use the European Commission "Market Access Database" https://madb.europa.eu/madb/datasetPreviewFormIFpubli.htm?datacat_id=IF&from=publi


As to Iran it shows for example the form "Application for a medical device registration" to be filled in (see attachment).

 

[Stijloor]

No matter, where you want to register, there is one good way to find out almost everything.

When you export from EEC use the European Commission "Market Access Database" https://madb.europa.eu/madb/datasetPreviewFormIFpubli.htm?datacat_id=IF&from=publi


As to Iran it shows for example the form "Application for a medical device registration" to be filled in (see attachment).

It appears that the link you provided is restricted.

 

[Chinquada]

The link is not protected.
Alternative:
simply enter "Market Access Database" in Google-Search.
Choose "Procedures and Formalities", enter your country you wish to export to incl. your product code and on the very right side of the result all necessary actions, incl. registration will be shown.

 

[MIREGMGR]

The link is not protected.
Alternative:
simply enter "Market Access Database" in Google-Search.
Choose "Procedures and Formalities", enter your country you wish to export to incl. your product code and on the very right side of the result all necessary actions, incl. registration will be shown.

The workaround has the same issue, i.e. the webpage looks at the visiting IP and geolocates on that basis, and refuses access if the IP is located outside of an EU member, or (I'm guessing) a candidate or cooperating country. In particular, access is denied from USA.

But, ultimately that doesn't matter because the content naturally will be specific to EU exporters.

The thread OP is located in UK, so the response may be useful there.

 

[Mondo 22]

Are banks accepting money/ trade with Iran?

 

[MIREGMGR]

That depends on where you are.

US companies are subject to many restrictions, which keep changing. My understanding is that many banking interactions with Iran, directly or indirectly, are currently illegal.