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2015 Sudan Medical Device Registration and Labeling Language Requirements

funkgirl

Involved In Discussions
#1
Has anyone started registration in Sudan for the 2015 implementation?

How long to approval?
Is Arabic truly compulsory or were you able to use English labeling?

Thanks for any info!
 
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Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!
 
P

PFD2010

#3
Hi There,

I'm sorry to say the both Arabic and English are required on product labels. In addition, all registration documents are to be submitted in English and/or Arabic. If there is any original documentation that is not in either English or Arabic, a certified translation endorsed by the Sudan Ministry of Foreign Affairs is accepted

Hope it helps
 
M

MPiska

#4
Hi PFD2010,

Do you have the documented requirements for the languages?

The guideline document I have (attached) states:

11) Provided that safe and correct use of the device is ensured, the labelling must to be in Arabic and/or English language(s).


Although as of this moment I don't have a full copy of the actual regulations.

Thanks,

MP.
 

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