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

Slides:

Advertisements

Similar presentations

JFDA & HAI Workshop Towards equitable and affordable medicine prices policy in Jordan 4-5 December 2007 Strategies to aid market entry and competition.

Advertisements

Panel themes of the International Conference “Europe against Counterfeit Medicines” G.N. Gildeeva, Deputy head of the Department of Registration of Medicines.

510k Submission Overview Myraqa, Inc. August 22, 2012.

1 Physician-Industry Transparency: The U.S. Physician Payment Sunshine Act.

REPUBLIC OF MACEDONIA HEALTH SYSTEM -OVERVIEW AND CHALLENGES- Minister of Health Bujar Osmani, MD SEECP Health Ministerial Meeting “Achievements and challenges.

 Sino Waypoint Consulting Inc. 1 Wenqin Shao Sino Waypoint Consulting Inc. China Medical Device Industry.

Careers in Biomedical Engineering Technology BMET 4350 Fall 2003 Dr. Hugh Blanton.

1 FDA Thailand By HIV Module/Marketing Group Mr. Manaswee Arayasiri.

Overview of Medical Devices Sector Saudi Food and Drug Authority (Saudi Arabia) Dr. Saleh Al Tayyar Director General Medical Devices Sector Saudi Food.

Erik Hansson DG Health and Consumer Protection (DG SANCO) European Commission Developments on product safety in the EU.

Healthcare Reforms and Pharmaceuticals Lessons from Turkey Prof. Dr. Mehtap Tatar Hacettepe University Faculty of Economics and Administrative Sciences.

FDA Regulatory review in Minutes: What Product Development Executives Need-to-Know. Specifically, frequent causes of recalls and related areas that investigators.

Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.

Market Surveillance in Republic of Turkey on Medical Devices Meral YILMAZ – Osman ARSLAN Ministry of Health Directorate General for Curative Services.

INTRODUCTION TO RA.

Incident Reports and field Safety Corrective Action ( FSCA) Eng. Essam M. Al-Mohandis Executive Director of Surveillance and Biometrics.

Healthcare Exco Report May CMS Broker Policy Document Document applies to any person who provides services in terms of the Act and Regulations Accreditation.

Cavendish Scott, Inc. 1 Regulatory and Statutory Compliance: It’s Everybody’s Business! Diana Lough Cavendish Scott, Inc.

The market surveillance use for deal against the counterfeited products (Problems and solutions) UNECE International Seminar on Product Safety and Counterfeiting.

SALDA Presentation to the Honourable Portfolio Committee on Health National Health Act Amendment Bill B March 2012.

Documents as quality manual, Annual quality report and product descriptions, Compensation for harm to health Prof. Juozas Galdikas State health care accreditation.

PSO Overview for Executives (Presenter) (Date) Center for Patient Safety Toolkit for PSO Participation, Section 4.

MEDICAL experts INDUSTRY Some of our clients. Pharmaceutical companies, manufacturers of medical and surgical devices, clinical research organizations,

1 REPUBLIC OF TURKEY PRIME MINISTRY UNDERSECRETARIAT OF FOREIGN TRADE General Directorate of Standardization for Foreign Trade Presented by Selin ÖZŞAHİN.

The Quality Colloquium at Harvard University August 27, 2003 Patient Safety Organizational Readiness Assessment Tool Louis H. Diamond, MDBeverly A. Collins,

Management of Change ► The health, safety, security, environmental, technical and other impacts of temporary and permanent changes are formally assessed,

HEALTH QUALITY IN LITHUANIA PROF. JUOZAS GALDIKAS DEPUTY DIRECTOR THE STATE HEALTH CARE ACCREDITATION AGENCY UNDER THE MINISTRY OF HEALTH UTRECHT, 2003.

IPASA presentation to Portfolio Committee on Health 31 October 2014 Abeda Williams.

UPCOMING CHANGES TO IN-VITRO DIAGNOSTICS (IVDs) AND LABORATORY DEVELOPED TESTS (LDTs) REGULATIONS Moj Eram, PhD November 5, 2015.

MEDICAL SERVICE ADMINISTRATION VIETNAM MINISTRY OF HEALTH

Energy Georgi Simeonov European Commission DG ENER, Radiation Protection Unit (D3) Justificação e Optimização das Exposições Médicas a Radiações Ionizantes.

The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Presented by J. Glenn George Thursday, March 29, 2007 Day II – Track.

Uniformal barcode processing for patient safety and efficiency Brief Proposal Esther Peelen, GS1 en Erik Zwarter, ErasmusMC 19 October 2015.

REGULATION OF MEDICAL DEVICES INNOVATION TUĞÇE YAŞAR

Healthcare Personnel Influenza Vaccination Reporting: Pilot Test of National Quality Forum Measure Centers for Disease Control and Prevention California.

When Supply Chain meets Care Delivery: Background on GS1 and HL7 Ulrike Kreysa Director Healthcare, GS1 Global Office.

TF_Arusha_Jun10/1 Framework for Evaluation of Male Circumcision Devices Tim Farley Department of Reproductive Health and Research World Health Organization.

Slide 1Paul Chavez, Logistics ManagerSlide 1Paul Chavez, Logistics Manager CALIFORNIA CLINICAL LABORATORY ASSOCIATION Date: November 5, 2015, 4:30 – 5:00.

R EGULATING THE IMPORTATION & USE OF MEDICAL DEVICES.

MINISTRY of HEALTH TURKISH MEDICINES AND MEDICAL DEVICES AGENCY Evren ALĞIN YAPAR Pharm MSc PhD Head of Department of Cosmetics Coordination.

Financing Healthcare Infrastructure – Perspective of the Islamic Corporation for the Development of the Private Sector (ICD) Saeed Jaweed Ahmad October.

THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS Responsibility in the handling of medical devices.

M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 1 – Free movement of goods Bilateral.

Health and Consumers Health and Consumers Introduction to the new Medical Device Regulations and their impact on medical software DG for Internal Market,

Global Clinical Engineering Success Stories Product Tracking System Project Name: Tuncay BAYRAK (Assistant Health Expert/Biomedical Engineer) Affiliation:

Global Clinical Engineering Success Stories Establishment of National Health Technology Management System for Public Hospitals Name: Bilal BECEREN Affiliation:

Frankie Wallace Supplier Engagement Lead

Regulatory Updates Health Sciences Authority Singapore

Update on EU regulatory developments

The European Association Medical devices

In-house Endoscope Support

Australian Jurisdictional Update March 2017

Submitted by Name: Libin

UTS PROJECT Disseminating Citizen-Oriented mHealth Services via Product Tracking Mobile Application in Turkey May 08, 2017 Seyfullah DEMİR Software Engineer.

World Health Organization

Bhutan’s experience on TA projects in improving national CRVS system

REGISTRATION & COLLECTING DATA ON CAUSE OF DEALTH IN HEALTH SECTOR

Proposal for a Regulation on medical devices and Proposal for a Regulation on in vitro diagnostic medical devices Key Provisions and GIRP Assessment.

What does EMRAM enable for better healthcare quality?

21 NOVEMBER 2018 FREE STATE PROVINCE

The European Association Medical devices

The European Association Medical devices

17 JANUARY 2019 MPUMALANGA PROVINCE

The most popular professions in America

Software for tracking and prediction of performances of MDs

EUnetHTA Assembly May 2018.

Pacific Regional Workshop on Legal Identity and Identity Security 8-10th July 2019 PALAU Efrecia R. Kazuma.

President and Chief Executive Officer

GMP Legal Framework in Kyrgyzstan

PHARMACOVIGILANCE SYSTEM

Presentation transcript:

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

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

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

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

Single Product Identifier Turkish Medicines and Medical Devices Agency

Single Product Traceability Turkish Medicines and Medical Devices Agency

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

ÜTS Timeline - 2 Turkish Medicines and Medical Devices Agency

ÜTS Tracking Transition Plan MD Class Start Date Optics 11.09.2017 Started AIMD 02.07.2018 Started Class III 01.10.2018 Started Class IIb Planned Class IIa Class I IVDs Turkish Medicines and Medical Devices Agency

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

To Sum Up Turkish Medicines and Medical Devices Agency

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. tuncay.bayrak@titck.gov.tr +903122183250 www.titck.gov.tr http://uts.saglik.gov.tr/ THANK YOU Turkish Medicines and Medical Devices Agency