2015 Sudan Medical Device Registration and Labeling Language Requirements

funkgirl

Involved In Discussions
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!
 

Stijloor

Leader
Super Moderator
A Quick Bump!

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Thank you very much!
 
P

PFD2010

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

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.
 

Attachments

  • guideline for MD registeration.docx
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