Product Labeling and IFU Language requirements for Turkey

J

Jwreeves

#1
Can anyone please provide current language requirements for labeling (product labeling and IFUs) for Turkey?

My understanding is that both English and Turkish are acceptable. However, I have heard that Turkish was becoming manditory.

Thanks for help.
 
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sreenu927

Quite Involved in Discussions
#2
Hi Jwreeves,

The product labels must be in Turkish. However,if instructions on product labels are clear enough making use of Universal symbols that conform to harmonized standards, then translation is not required.

IFU/User Manuals/product inserts must be in Turkish.

Advertising material can be in English. No translation is required.

Regards,
Sreenu
 
M

Mickey1102

#3
Do you have evidence documents like guideline published by Turkish competent authorities?

Kind regards,
Mickey
 
N

nadavreu

#4
Hi

I agree with Sreenu

The product labels and IFU must be in Turkish OR Arabic . However in your submission for Turkish authority IFU and labels must be in English and Turkish with full similarity.

Advertising material can be in English. (for Academic and industrial institutions I recommended that the material will be written in English)

Nadav
 
Last edited by a moderator:
M

Mickey1102

#5
Thank you Sir.
If you have the any guidance concerned, we would appreciate it if you could attache them in this website.

Kind regards,
Mickey:applause:
 
K

KaCey1

#6
Hi,
In this regard I was wondering if there is any requirement to translate the User Interface of electronic devices from English to Turkish?

Also if a company is based in the EU do they require an Authorised Representative in Turkey?

Any help will be appreciated

Regards
 
D

DavidHedfors

#7
Thank you Sir.
If you have the any guidance concerned, we would appreciate it if you could attache them in this website.

Kind regards,
Mickey:applause:
This link is a translated version of the Turkish law implementing MDD. See Article 6. <Sorry, can't post links cause of forum rules...>
Ok, go to google translate, enter saglik.gov.tr, go to website, Health Legislation, Regulations (second from top), Regulation of Medical Devices, click for additional documents, go to Article 6.

Article 6 - (1) subject to conformity assessment procedures maintained in accordance with the provisions of this Regulation and CE marking of medical devices attached to the supply can not be prevented or services offered on the market. (2) The following CE mark is not attached to the device and can not be any obstacles for these situations:
a) comply with the requirements in Annex VIII and Article 15 of devices for clinical research, medical practitioner or clinical research making use by authorized persons,
b) Annex VIII is mentioned declaration has to be provided that these regulations according to custom-made medical devices by name or identification number with a particular II patients Class offered the use of, IIb and III they offered medical devices to the market and service.
(3) provisions of this Regulation to non-conforming medical devices, can not be marketed until fulfilled Regulation and services can not be provided with a mark bear record shows clearly, places notation as trade fairs and exhibitions inevitable.
(4) Annex I (13) to patients specified by the number of and the manufacturer, information to be given to users and practitioners with the medical device, user manuals, labels, maintenance booklet and other disclosures must be Turkish When medical devices placed on the market.
 
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