Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt

belemsanchez

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#1
Hi, please, I have a doubt about who is the owner of the medical devices's register in the following countries: Iran, India, Jordan, Arab Saudi, Egypt.

Our company is not the manufacturer, but we are the marketer of the medical devices.

:thanx:
 
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M

MIREGMGR

#2
Are you asking whether the device's physical maker or its marketer is the regulatorily responsible party in each of those countries?

In most cases, the regulatorily responsible party "owns" (creates, keeps current, and pays for) the product registration.
 

belemsanchez

Involved In Discussions
#3
Thanks for the reply.

My question is because in several countries the distributor/holder or the third party is who register the medical devices, and for this, he is the owner of the register.
In this case, if we finish the relationship for example, with the distributor, we will have a problem if this distributor doesn't want to change the register owner name.

This is my doubt. Thanks
 
M

MIREGMGR

#4
Your question then has to do not with medical device regulation per se, but with the societally based legal practice in some of these countries (not Jordan?) of guaranteeing that a local person gets an assured "piece of the action" in regard to distribution of imported products, by making it legally impossible to break a contract with that local person to participate in such distribution without paying that person for the ability to break the contract.

This applies to all sorts of business dealings, not just medical devices.

This is common in countries that use Sharia based legal systems, and in countries with colonial histories.
 
Last edited by a moderator:

tibon74

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#5
Hello,

Is it true that we can have only one authorized representative un Saudi Arabia?
Could foreign manufacturer have several authorized representatives according to products

Regards

Taieb
 

belemsanchez

Involved In Discussions
#6
Saudi Arabia new MDNR (class I)

Hi, please, I have some questions about Arabia Saudi registration:

  • is possible to add an accesory to MDMA? we have a new medical device and it's an accesory, and I'm not sure if my MDMA can be extended.
  • new MDNR, our distributor in Arabi Saudi says me that SFDA requires all my procedures for check my QMS, he says that the ISO 13485 is not enough, is normal that SFDA ask for this requirement?
  • Do you know where I can get the guideline of how to get the registration using the new MDNR route (low-risk)?

:thanx:
 

belemsanchez

Involved In Discussions
#7
Hi, now I have a doubt with Saudi Arabia registration (SFDA).

We want to do the registration of a MD class I (its a n accesory). And our local distributor has said to me that now is posible to speed the proccess with the new system MDNR.
And now, our distributor has received the following requirement, - You have to upload Quality management system.

Does anyone know if that means that it is necessary to upload all our procedures of quality? I think that it must mean upload the ISO 13485 certificate of the manufacturer, but our local distributor insisits that it means upload our procedures of quality. Sure? because I thibk that is the reason why the Quality systems are audit.

:thanx:
 
#8
Dear all,

I have a query regarding registration of medical devoces in Iran.

The local representative : Does the local distributor become a sole distributor in Iran for the exporting company?

If yes, does the local authorised representative become for distributor product by product, or for the whole company?

If yes, for how long?

Thank you,
Best regards,
Primate
 
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