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

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

1. Yes, there are regulations for medical devices in Iran - refer this website - Medical Equipment - Quality and Price Regulatory Department (http://www.imed.ir/en/catalog/page.asp?id=22)

2. I am not sure of EU but US FDA has some requirement. Refer section 746.7 on page 1 Fed Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-682.pdf) for more details.

Additionally, there is a CDRH Foreign Liaison List (http://www.fda.gov/CDRH/devadvice/391.html#I) in US.

You had better check with the US State Department on this one.

Thanks Guys, Chris

You have to submit a file including a form from the Iranian Health Authority (IMED) : with Google search "application medical device iran"

You had better check with the US State Department on this one.

Actually, I think the Commerce Department.

For companies located in the US or wanting to do business in the US, or intending to ship medical devices originating in the US to Iran, the embargo has the force of US federal law under the broad-scope International Emergency Economic Powers Act. Penalties can be severe. Shipment by Company X located outside of the US of goods obtained from Company Y in the US can cause Company Y to be found to be in violation of US law and penalized, if there is evidence that they knew or should have known where their goods eventually were headed.

http://www.bis.doc.gov/policiesandregulations/regionalconsiderations/iran.pdf

I am currently pretty far along in the process of getting a license to ship new and repaired medical devices to Iran. Here is where I started:

www.bis.doc.gov/licensing/exportingbasics.htm (http://www.bis.doc.gov/licensing/exportingbasics.htm)

Step 1. Apply for a User ID and Pin from the Bureau of Industry and Security (BIS) to use SNAP-R to apply electronically for a license, which requires that you first prepare and submit a company certification letter.

Step 2. Receive an official notification from BIS that the device is 'EAR99' (understand upfront that the ECCN for medical devices is 'EAR99', so you don't need to waste your time searching through the commerce control list to figure it out).

Step 3. Submit electronic application to Office of Foreign Assets Control (OFAC) using SNAP-R, which requires that you have already obtained official notification of EAR99 from BIS.

Step 4. Wait.....(this is where I am in the process)

This is only one of many, many things that I have on my plate right now, both professional and personal, so if you ask me questions and I don't respond in a timely manner, please don't be offended. :)

Hi,
I'm trying to export dental implants to Iran at the moment. We have an agent in Iran and we need three documents:
1. an authorization of the agent, legalized by both our local chamber of commerce and the consulate of Iran
2. a letter of commiment
3. a form of the ministry of health of Iran called "Application for a medical device registration"

Seems to be easy, doesn't it?
My first problem is the consulate of Iran sent my "authorization of the agent" doc back twice (without legalization), doesn't answer the phone and I didn't get a response to my email...
And the application form is not half bad, they want to know literally everything of your company...

regards, Britta

I see that you are in Germany, so I don't know how things are done there. But let me explain how I get documents 'consularized' here in the U.S. and maybe you can find something similar in your country. I first have the document notarized by our local chamber of commerce (to confirm that the product was manufactured in the U.S.), then FedEx it to a company called Washington Consular Services in Washington D.C. WCS first get the document signed by the U.S. Secretary of State (that's the legalization step) and then by the Iran Consulate in the U.S. (that's the consularization step), then FedEx it back to you. Absolutely not the cheapest way ($100-$200), but absolutely the best way of getting it done correctly and expeditiously. I'm sure there are other companies like WCS, I just found them on the internet and have been using them for around 2 years without any problems. I hope this helps.

Hi Marc,

The consulate answered my call before the election in Iran. Now, since the protests down there started, they stopped communication... Maybe the consulate waits until things cool down again before they start talking to me again... But I will remember your advise. When they do not answer next week I am going to try it your way.

Regards, Britta

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

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...:frust:), 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