G/TBT/N/TUR/35  
 
12 April 2013  
(13-1918)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  TURKEY  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Ministry of Health 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
Ministry of Health 
DG of Foreign Relations and EU 
Mithatpa şa Cad. No : 3 06434 S ıhhiye - Ankara / Turkey 
Tel.:  +90 (312) 585 1000 Website:  http://www.saglik.gov.tr/  
OR 
Turkey-TBT Enquiry Point 
Ministry of Economy  
DG of Product Safety and Inspection 
Inonu Bulv. No:  36 06100 Emek- Ankara / Turkey  Tel.:  +90 (312) 204 8074 
Fax:   +90 (312) 212 6864 
E-mail:  tbt@ekonomi.gov.tr  
Website:  http://www.teknikengel.gov.tr  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
Devices and Active Implantable Medical Devices  
5. Title, number of pages and langua ge(s) of the notified document:  Draft 
Communiqué on Electronic Instructions for Use of Medical Devices (5 pages, in Turkish).     
6. Description of content:  This Draft Communiqué covers the procedures and principles for 
the preparation of contents of hard-copy instructions for use, electronically; and, the online applications of these instructions in related web sites for medical devices which are in the 
scope of Regulation on Medical Devices and Regulation on Active Implantable Medical 
Devices. In addition, hard-copy instructions for use are replaced by electronic instructions for use.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information.  G/TBT/N/TUR/35 
 
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  8. Relevant documents:    
- Law No. 4703 on the Preparation and Enforcement of Technical Regulations; 
- By-Law No. 663 on the Organization and Functions of the Ministry of Health and its 
Subsidiaries;  
- Annex 1 - Article 13 of the Regulation on Medical Devices; - Annex 1 - Article 15 of the Regulation on Active Implantable Medical Devices. 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
10. Final date for comments:  - 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
Turkey-TBT Enquiry Point 
Ministry of Economy  
DG of Product Safety and Inspection 
Inonu Bulv. No:  36 06100 Emek- Ankara / Turkey  Tel.:  +90 (312) 204 8074 
Fax:  +90 (312) 212 6864 
E-mail:  tbt@ekonomi.gov.tr  
Website:  http://www.teknikengel.gov.tr  
OR 
Ministry of Health 
DG of Foreign Relations and EU Mithatpaþa Cad. No : 3 06434 Sýhhiye - Ankara / Turkey 
Tel.:  +90 (312) 585 1000 
Website :  http://www.sa glik.gov.tr/  
The electronic version of the regulatory text can be downloaded at:    
http://members.wto.org/crnattachments/2013/TBT/TUR/13_1453_00_x.pdf