1. National implementation on unique device identification for medical devices in Turkey
Tuncay BAYRAK, M.Sc.
Biomedical Engineer
December 2018

2. COUNTRY OVERVIEW Population ~81 million Hospitals 1600
Market Size (Billion Dollar)
2.3
Total Healthcare Expenditure ratio (%)
6,0
World market ratio (%)
0,7
Import (%)
85,1
Per capita (Dollar)
29,2
Establishments
7475
Turkish Medicines and Medical Devices Agency

3. Total number of staff for medical device departments : 111
HISTORY/BACKGROUND
Turkish Medicines and Medical Devices Agency (TITCK)
President Dr. Hakkı Gürsöz
Established in 2012
Affiliated agency with MoH
Total number of staff for medical device departments : 111
Turkish Medicines and Medical Devices Agency

4. ÜTS PURPOSE TİTUBB-Turkish Medicines and Medical Devices Databank 2007
Registration to TİTUBB (Information about product / importers & manufacturers / distributors
Barcode based
Product Tracking System (ÜTS) (2017)
Unique based tracking
To keep record of medical devices and cosmetic products
To establish a National and Original infrastructure that can keep track of products
Patient safety and protection of public health
Efficient execution of inspection services
Taking rapid measures for possible risks occuring during use of the products
provides an infrastructure to track medical devices manufactured or imported to the place where they are sold and used.
Turkish Medicines and Medical Devices Agency

5. Single Product Identifier
Turkish Medicines and Medical Devices Agency

6. Single Product Traceability
Turkish Medicines and Medical Devices Agency

7. ÜTS Timeline - 1
Starting legal proceedings for optical medical devices
Turkish Medicines and Medical Devices Agency

8. ÜTS Timeline - 2
Turkish Medicines and Medical Devices Agency

9. ÜTS Tracking Transition Plan
MD Class
Start Date
Optics
Started
AIMD
Started
Class III
Started
Class IIb
Planned
Class IIa
Class I
IVDs
Turkish Medicines and Medical Devices Agency

10. Statistics As of November 2018:
Company
QTY
Manufacturer/Importer/Dealer
6,300
Healthcare Providers
1,554
Total (including others)
29,315
Total Movement Notification is 140,200,065
only for AIMD + Class III
Document
QTY
EC Certificates
13,849
DoC
95,719
IFU
71,445
Total (including others)
189,965
Product
QTY
Class I
1,845,790
Class IIa
259,918
Class IIb
460,697
Class III
225,919
IVD
39,871
Total
2,902,134
Turkish Medicines and Medical Devices Agency

11. To Sum Up
Turkish Medicines and Medical Devices Agency

12. ÜTS Portal
Information about the new versions, training materials, news on workshops conducted and up to date information about the project are published in the portal.
Contact Information
Tuncay BAYRAK
Health Expert, Biomedical Engineer, M.Sc.
THANK YOU
Turkish Medicines and Medical Devices Agency