Medical Device Registration Process in Iran

C

Caroline S

Dear all,

I am seeking medical device registration process in Iran.

Thanks in advance to anyone who can help me.

Caroline S.
 
B

Burgmeister

No mention of labelling language requirements on that form. Is English sufficient?
 

Rocke

Involved In Discussions
No mention of labelling language requirements on that form. Is English sufficient?

For IVDs Persian Instructions for use are required according to my information.
Our product label is English, but our distrobutor adds a label with their information in Persian.
 
D

dodonnel

We have a class III active implantable device. Is there a requirement to include patient manuals?
 

tibon74

Involved In Discussions
Hi !! could I have some details on the Iran regulation ?
Should we appoint a local representative? who is the license owner ? how much time it takes to approve a product? is there a renewal process ? if so, when ?
thank you !
 
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