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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
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Export of Medical Devices to Iran - Medical Device Regulations in Iran

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Related Topic Tags
exports and exporting, iran, medical devices (general)
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  Post Number #1  
Old 13th February 2009, 10:23 AM
chris1price

 
 
Total Posts: 174
Please Help! 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

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  Post Number #2  
Old 13th February 2009, 10:55 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,737
Re: Export of Medical Devices to Iran

1. Yes, there are regulations for medical devices in Iran - refer this website - Medical Equipment - Quality and Price Regulatory Department

2. I am not sure of EU but US FDA has some requirement. Refer section 746.7 on page 1 Fed Register for more details.

Additionally, there is a CDRH Foreign Liaison List in US.
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  Post Number #3  
Old 13th February 2009, 11:23 AM
Randy's Avatar
Randy

 
 
Total Posts: 8,273
Re: Export of Medical Devices to Iran

You had better check with the US State Department on this one.
  Post Number #4  
Old 13th February 2009, 11:42 AM
chris1price

 
 
Total Posts: 174
Re: Export of Medical Devices to Iran

Thanks Guys, Chris
  Post Number #5  
Old 3rd June 2009, 10:11 AM
Julien France

 
 
Total Posts: 1
Re: Export of Medical Devices to Iran

You have to submit a file including a form from the Iranian Health Authority (IMED) : with Google search "application medical device iran"
  Post Number #6  
Old 3rd June 2009, 11:29 AM
MIREGMGR

 
 
Total Posts: 3,419
Re: Export of Medical Devices to Iran

Quote:
In Reply to Parent Post by Randy View Post

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/policiesandre...tions/iran.pdf
  Post Number #7  
Old 18th June 2009, 05:50 PM
AOIRA

 
 
Total Posts: 26
Re: Export of Medical Devices to Iran

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

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.
Thank You to AOIRA for your informative Post and/or Attachment!
  Post Number #8  
Old 25th June 2009, 11:46 AM
Katze

 
 
Total Posts: 3
Re: Export of Medical Devices to Iran

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
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