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Related Topic Tags
instructions for use (ifu), labeling requirements, language requirements, saudi arabia, translations (languages), medical devices (general), labels and labeling (general)
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  #1  
Old 20th May 2009, 03:26 AM
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Please Help! Mandatory Language Requirements Saudi Arabia

Hi guys,

I wonder if anyone knows the mandatory language requirements for Saudi Arabia (for label and display, safety instruction and IFU)?
Any idea will be highly appreciated. Since I've been working on an internal translation procedure, I might ask some more questions for other countries as well.

Thanks in advance!

Rgds,
Guido

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  #2  
Old 20th May 2009, 03:48 AM
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Re: Mandatory Language Requirements Saudi Arabia

Hi NEwRegMan:

I found this on google.

http://commerce.nic.in/trade/GCC%20N...i%20Arabia.doc.

It has something on Labelling and Marketing requirements.

Also,
http://www.fsis.usda.gov/regulations...ents/index.asp

Ciao.

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  #3  
Old 21st May 2009, 04:31 AM
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Re: Mandatory Language Requirements Saudi Arabia

Hii..

Sometime back, I have prepared a Regulatory Master List for most of the countires with product registrations requirements.

It may be of some use for you!! for afew countries, regulations might have changed. plz verify before using the same.

Regards
Sreenu
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: xls Regulatory Requirements Master Lsit.xls (121.5 KB, 350 views)
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  #4  
Old 21st May 2009, 11:29 AM
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Re: Mandatory Language Requirements Saudi Arabia

Sreenu, Thanks for the chart! Nicely organized. However I was unable to discern the label and DFU language requirements for any given country (I think that's what started this thread). Was I missing something?
  #5  
Old 21st May 2009, 11:36 AM
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Re: Mandatory Language Requirements Saudi Arabia

Quote:
In Reply to Parent Post by Watchwait View Post

Sreenu, Thanks for the chart! Nicely organized. However I was unable to discern the label and DFU language requirements for any given country (I think that's what started this thread). Was I missing something?
Not fully understanding the chart, I would guess that the Color code is the key.

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  #6  
Old 21st May 2009, 11:55 AM
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Re: Mandatory Language Requirements Saudi Arabia

Quote:
In Reply to Parent Post by Coury Ferguson View Post

Not fully understanding the chart, I would guess that the Color code is the key.
The color code is explained on most (but not all) of the tabs in the workbook:


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Old 21st May 2009, 09:56 PM
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Re: Mandatory Language Requirements Saudi Arabia

Thank Jim for identifying it and clarifying:-) I shall work on it again to update with the latest regulations, since India, Singapore have enforced medical device regulations.

Reg the IFU and label language requirements for Saudi, I tried to trace e-mail response form some authority from Saudi FDA, but I cudn;t get so, however, I remember, Arabic is a must along with English as per Saudi FDA regulations.

Regards
Sreenu
  #8  
Old 25th May 2009, 01:53 AM
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Re: Mandatory Language Requirements Saudi Arabia

Thanks for the great help,

I will keep on searching for Saudi Arabia regulations but Arabic + English can not be wrong anyway.

Best regards,
Guido
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