Class III Medical Device Registration and Requirements in Iraq

S

Slayer_ch

Hello all,

Does anboy have an idea what is needed to register a CLASS III Medical Device in Iraq?

We would ship the products out of Switzerland.

I couldn't find anything about this.

For me it looks like there is nothing needed?!?!

Any help would be very appreciated.

Thanks
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Medical Device registration in Iraq

Does anyone have some insight for Slayer_ch?
 
S

Slayer_ch

Re: Medical Device registration in Iraq

I found one excel list in this Forum where they say it's only a Letter of authorization (for distributor) required. I hope this is correct.
 
M

MIREGMGR

Re: Medical Device registration in Iraq

If you haven't done so already, you might want to check with the Commercial Counsel at the Iraqi Embassy or Consulate nearest you.
 
S

Slayer_ch

Re: Medical Device registration in Iraq

I just got the information form an Iraqi Surgeon that nothing is required. Very good.
 
M

MIREGMGR

Re: Medical Device registration in Iraq

Different companies may have different approaches, but we would never utilize input from a single individual, physician or not, as our sole basis for a regulatory compliance plan.
 
S

Slayer_ch

Re: Medical Device registration in Iraq

What do you do then in case of Countries like this?
 
M

MIREGMGR

Re: Medical Device registration in Iraq

One idea: see four posts up.

Another idea: check with the Commerce Department, or national equivalent, of the nation from which you will be exporting, and get their assistance in that export process.
 
M

Mickey999

Re: Medical Device registration in Iraq

I don’t have experience with Iraq specifically, but I have registered a Class III device in Iran which similarly did not have any set requirements for registration. We chose to submit a basic registration package with CE and ISO certificates, system drawings, labels, IFUs, and mfg flow diagram.

Prior to export, one thing you might need to look into is trade sanctions through the Office of Foreign Assets Control (OFAC). The requirements for Iran were extensive and required a license to export and I imagine it would be similar for Iran. I hope this helps a bit.
 
B

Burgmeister

Re: Medical Device registration in Iraq

Did anyone manage to get a definitive answer to this? I have a Class IIb device that we would like to distribute in Iraq but getting information is proving a nightmare. The device is CE marked and 510(k)'d. I have contacted the Iraqi Embassy, Iraqi Ministry of Health and UKTI but no-one wants to respond and I need an answer rather quickly, so if anyone can help I would be most grateful.
 
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