Multiple registrations / authorized representatives in Iran

3

3l5m4r

Hi there,

I have a rather common question - this time with regards to Iran:

Is it possible to register one medical device multiple times in Iran? I.e. if a local distributor does the registrations and therefore then also holds the registrations, will it be possible to appoint another authorized representative some time later, in case other distributors want to market the same products?

I've checked other threads in this forum and actually wanted to post the links here, but apparently, I'm not allowed to post any links yet, since I haven't made more than 10 posts yet. :|

...anyway: unfortunately, I haven't found any Information on that in the other threads. I'd be glad if anyone could help...
 
S

Sarah Stec

Re: Multiple registrations / authorized representatives in Iran?

In doing a bit of research on this earlier, I seem to recall a requirement that a foreign company can't have more than one domestic representative. So this may mean that you wouldn't be able to have more than one distributor. In any course, it may be up to the registration holder whether or not they want to have someone else market the product.

This assumes, of course, that you aren't beholden to any sanctions or need any special licenses with respect to your product.

If someone deals with this more often, I'm happy to be corrected.

:bigwave:
 
3

3l5m4r

Re: Multiple registrations / authorized representatives in Iran?

thanks, Sarah. do you have any official statement or anything supporting that? or is this based on experience?
 
3

3l5m4r

Yes, I've come across the document, but it doesn't answer my question. In fact, it doesn't even mention that an authorized representative is necessary.
 

Eric Gasper

Perpetual Quality Learner
Leader
PQ Systems
Welcome @MDTM2022

Unfortunately, 315m4r is no longer an active user on Elsmar, so likely no response will come from them. Hopefully others could weigh-in though!
 
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