Mandatory Language Requirements Saudi Arabia

NewRegMan

Starting to get Involved
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
 

sreenu927

Quite Involved in Discussions
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
 

Attachments

  • Regulatory Requirements Master Lsit.xls
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W

Watchwait

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
Trusted Information Resource
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.
 

Jim Wynne

Leader
Admin
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:

picture.php
 

sreenu927

Quite Involved in Discussions
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
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
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
 

Attachments

  • MedicalDeviceinterimregulation.pdf
    156 KB · Views: 226
Last edited:
M

madhunaresh

Hi Sreenu,

Do you have an updated Regulatory requirements master list?

Regards
Madhu
 
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