TURKISH NATIONAL MEDICAL DEVICE DATABASE (TITUBB)

Funda ÖZDİLER*, Esra DEMİR*, M.Doğan ERDEN*, Osman Arıkan NACAR*, İsmet KÖKSAL*, Ercan ŞİMŞEK* funda.ozdiler@titck.gov.tr, esra.demir@titck.gov.tr

*Republic of Turkey Ministry of Health Medicines and Medical Devices Agency, Department of Medical Devices, Ankara, TURKEY

INTRODUCTION

The healthcare system in Turkey has entered a long period of development in 2003 called “Health Transformation Project “. Turkish National Database for Medical Devices, a.k.a TITUBB, came into force in 2004 as part of the "Strengthening of Health Services Financial Management and Restructuring Project". TITUBB is an electronic catalogue system that aims to comprehend end-to-end healthcare supply chain, together with public surveillance and vigilance capabilities. Turkish National Database provides barcode level tracking and on the verge of signing a protocol with customs in order to fight against counterfeiting. The registration process constitutes of 3 steps starts with company, document and medical device registration. TITUBB approval is the first step for reimbursement and the information provided via TITUBB is being used by other national authorities (Procurement Agency, Social Security Agency ) as well. TITUBB also provides some statistical datas related with local manufacturers, dealers, public procurement prices and reimbursement datas.

Online Registration System: • Medical Devices, within the scope of Medical Device (93/42/EEC), Active Implantable Medical Devices (90/385/EEC) and In vitro Diagnostic Medical Devices • 98/79/EEC Directives • Manufacturers or Importers can only register

Medical device manufacturers (if located in Turkey), importers complete their application by filling "Company Registration Form" of the TITUBB system on the internet. Company Registration Form;

Firm/Institution Name Tax ID number Authorized Person Citizenship number Authorized person e-mail adrress Decleration of signature Start date of Business Activity Field Contact info,

DOCUMENT REGISTRATION

ISO 13485 Quality Management System Certificates, Authorized Distributor Documents, User Manuals, Catalogs, EC Certificates, Declaration of Conformity (as pdf) are defined to the TITUBB system by company’s authorized person. By checking the consistency of documents and information, notification shall be approved by the Ministry of Health.

Barcode

Medical Device Registration can be done through product number (barcode), GS1 (Global Standarts One) and HIBCC (Health Industry Business Council, Coding)

Registration can be done also with the barcode number assigned by the system.

Nomenclature

TITUBB uses international standards of the United Nations Standard Products and Services Code (UNSPSC) and

the Global Medical Device Nomenclature (GMDN) Working on National Nomenclature in coordination with other Related Parties.

Medical Device Registration Form;

Barcode Number (GS1, HIBCC ) Catalogue Number Branding Name UNSPSC and GMDN Classification Field Sterility Field Imported / Manufactured GTIP (Customs Tariff Number) Approved Documents (EC certificates, IFU, Decleration of Conformity…)

MEDICAL DEVICE REGISTRATION

Company 8546 (subsidiaries included)

Local Manufacturer 1333

Importer 2270

Medical Device

Manufactured Products 1.208.212

Imported Medical Devices 1.786.474

System Usage

Registered Users 61.481

Online Users 1.250

Daily Hits 3.326.763

Orthotics-Prosthetics Application Center

230

Opticians 5345

Hearing Aid Application Center

648

FUTURE PROJECTS WITH NATIONAL DATABASE FOR MEDICAL DEVICES IN TURKEY

TITUBB

English Version

Customs Entegration

(in two weeks)

Eudamed Entegration

UDI Entegration ?

Entegration with Central

Stock System of Governmental

Hospitals(MKYS) National Database for Medical Devices, called TITUBB, came into force in 14/07/2004 as part of the "Strengthening of Health Services Financial Management and Restructuring Project" by signing a protocol between the Ministry of Health, Ministry of Finance and Ministry of Labour and Social Security on the coordination of the Hacettepe University.

TITUBB registration process is completed within three steps ;

COMPANY REGISTRATION

BENEFITS

Development of reimbursement strategy based national statistics Regulating price fluctuations over time Providing an advanced e-procurement platform Capability of estimating total procurement costs based on evidence Regulating medical devices and market structure Strengthening post-market surveillance, Tracking of Custom-Made Devices and System or Procedure Pack (unnecessary and excess payment

will be prevented), Help out for new policies, Locate spesific product/company/subsidiaries with the geographical location application. Monitoring central stock of medical devices for MoH’s Hospitals. Promote public health by elimination of counterfeit products and suppliers,

References: 1) http://www.titubb.org/SitePages/Giri%C5%9F%20Sayfas%C4%B1.aspx 2) http://ubb.iegm.gov.tr/Forms/KurumGirisSayfa.aspx?show=self