Mandatory Language Requirements Saudi Arabia

NewRegMan

Starting to get Involved
#1
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. :confused:

Thanks in advance!

Rgds,
Guido
 
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W

Watchwait

#4
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?:thanx:
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#5
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?:thanx:
Not fully understanding the chart, I would guess that the Color code is the key.
 

sreenu927

Quite Involved in Discussions
#7
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
 

NewRegMan

Starting to get Involved
#8
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
 

bio_subbu

Super Moderator
#9
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

Dear Guido

Arabic and English languages are mandatory to fulfill the SFDA labeling requirements. For more details refer English version of Medical Device Interim Regulation which has being published in the official journal and can be accessed via sfda website (both Arabic and English version), it stated in chapter 6, article 18 A. 5:

The manufacturer or its authorized representative shall for the medical devices it wishes to place on the market of the KSA:

5. Provide a copy of the labelling associated with the medical device, in English and/ or Arabic language, and ensure that the text of the different elements of the labeling and their content take account of the intended use of the devices and the qualifications of the users in the KSA.

Attached is Medical device Interim regulation, hope you will find useful and informative.

Thanks and Regards
S. Subramaniam
 

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