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

Slides:



Advertisements
Similar presentations
REPUBLIC OF ALBANIA PUBLIC PROCUREMENT AGENCY Introduction to the Albanian Public Procurement System Central Asia Regional Public Procurement.
Advertisements

“Reform of the Child Care System: Taking Stock and Accelerating Action” South East Europe 3 – 6 July 2007, Sofia.
Croatian Government’s Priorities in the Regulatory Area UNECE-SIDA “South East Europe Regulatory Project” Ljubljana, 8 June 2004.
Implementation - Medical Devices. Overview Act on Medical Devices – background and overview. Surveillance - Competent authority. Directive 93/42. Directive.
REPUBLIC OF ALBANIA PUBLIC PROCUREMENT AGENCY 9th Public Procurement Knowledge Exchange Platform May, 28-31, 2013 Skopje
Product Safety and Market Surveillance Package
STATE OF THE ART AND PERSPECTIVES IN MEDICAL DEVICE LEGISLATION 3rd National Conference on Medical devices Roma, 13th April 2010 Sabine Lecrenier Head.
WORLD MEETING OF CUSTOMS LAW BRUSSELS , September “ Studies on Harmonization of Customs Law and Contributions of the Academy for updating and.
The Implementation of the Acquis into the Polish Official Statistics Special MGSC Meeting, Warsaw, 21 June 2002.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
1 ACCREDITATION – BG situation April 2014, Prague STATE AGENCY STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE TECHNICAL SURVEILLANCE 1.
S L O V A K I A. Since the 5 th meeting of CEFTA: Important changes have taken place in the Slovak Republic in the following areas: a/ further EC directives.
Turkey’s Experience on the Accession to ADR Convention
TRANSFORMATION OF CUSTOMS LEGAL FRAMEWORK Transition period from planned to market economy Kiev, March 17th, 2011.
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission 1 PECAs David Eardley DG Enterprise and Industry European Commission Tel: 032 (2)
Advisory group on fruit and vegetables 7 March 2008
1 REPUBLIC OF TURKEY PRIME MINISTRY UNDERSECRETARIAT OF FOREIGN TRADE General Directorate of Standardization for Foreign Trade Presented by Selin ÖZŞAHİN.
9th MARS Group meeting 13 – 15 September 2011 Bratislava, Slovak Republic Customs Administration of the Slovak republic Marián Haršány.
Control of implementation of the law on civil service and related legislation Arvydas Kazlauskas Chief specialist of the Division of Civil Service Terms.
Warsaw, 5 th November 2012 Market Surveillance System of non-food products in Poland.
Consumer protection in Macedonia 10 march, Zagreb.
Croatian Government’s Priorities in the Regulatory Area UNECE Round Table on Regulatory Cooperation in South East Europe Geneva, 22 November 2004.
WHO, Almaty 2002 Food Legislation of the European Union and its effect on Slovak legislation1 Food legislation of the European Union and its effect on.
Work Session on Statistical Data Confidentiality Access to Statistical Data for Scientific Purposes Helsinki, Finland, 5 to 7 October 2015 Presentation.
Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,
Twinning Project No 00MAC01/02/006: Approximation of Legislation to the Internal Market Acquis An EU-funded project managed by the European Agency for.
CONSUMER PROTECTION Slovak Customs Administration UNECE „MARS“ Group meeting 24 – 26 September 2006, Bratislava Bc. Viliam Pružinec, Customs Directorate.
MINISTRY of HEALTH TURKISH MEDICINES AND MEDICAL DEVICES AGENCY Evren ALĞIN YAPAR Pharm MSc PhD Head of Department of Cosmetics Coordination.
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 13 – Fisheries Vessel characteristics.
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.
CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA.
1 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 29 – Customs union Bilateral screening:
M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Working Group for Chapter 1 – Free movements of goods Bilateral.
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 27 – Environment Bilateral screening:
1 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 29 – Customs union Bilateral screening:
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 27 – Environment and Climate Change.
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.
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 31 – Common Foreign and Security Policy.
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 27 – Environment Bilateral screening:
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 27 – Environment and climate change.
Date: in 12 pts MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS Rita L'Abbate European Commission DG ENTERPRISE AND INDUSTRY.
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 28 – Consumer and Health Protection.
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 27 – Environment Bilateral screening:
ALBANIA Report in ICT development Albania is a member of eSEE WG and in this framework its achievements are: eSEE Agenda commitment 1.Adoption of National.
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 27 – Environment and climate change.
PRESENTATION OF MONTENEGRO
Update on EU regulatory developments
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
66 items – 70% of circulated products
Unit for Medical Systems and Devices at Ministry of Health
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
PRESENTATION OF MONTENEGRO
EU legislation on Personal Protective Equipment (PPE)
EU Reference Centres for Animal Welfare
PED AND PE SECTOR IN TURKEY
The Treaty of Lisbon and Administrative Cooperation
The Regional Workshop of Basel Protocol on Liability and Compensation (18-20 January, Warsaw, Poland) National Procedure for Ratification of International.
Bulgaria – Capital Budgeting And Fiscal Institutions
EU legislation on noise emission in the environment by equipment for use outdoors: latest developments September 2018 European.
Coordination of the National Statistical System of the Republic of Macedonia Kruševo, 2018.
Presentation transcript:

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

According to Article 8 of 1/95 numbered Association Council Decision between EU and Turkey, establishing the Customs Union between Turkey and EU, envisages that EU legislation on abolishing technical obstacles to trade shall be included in the internal legislation of Turkey. According to 2/97 numbered Association Council Decision between EU and Turkey the public institutions which will be harmonising the EU legislation are determined by the Cabinet Decision dated and 97/9196 numbered.2/97 numbered Association Council Decision between EU and Turkey the public institutions which will be harmonising the EU legislation are determined by the Cabinet Decision dated and 97/9196 numbered. 2

Council of Ministers assigned Ministry of Health for the harmonisation of the legislation on medical devices. 3

Necessary regulation for the effectively implementation of the technical legislation has been provided by 4703 numbered Act on “Preparation and Implementation of the Technical Legislation for the Products”. This act is the legal framework and it came into force on January 11th, numbered Act on “Preparation and Implementation of the Technical Legislation for the Products” 4

Based on this legal framework following Directives on medical devices have been harmonised by the Ministry of Health. 93/42/EEC Medical Devices Directive 90/385/EEC Active Implantable Medical DevicesDirective (These two regulations are in force since ) 98/79/EC In-vitro Diagnostic Medical Devices Directive (This regulation is in force since ) 5

Amendments of these regulations have been republished in the official gazette on Following amendments have been realised: Directive of 2000/70/EC on Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma, Directive of 2001/104/EC amending the Medical Devices Directive Council Directive of 2003/12/EC on Reclassification of the Breast Implants which amended Directive of 93/42/EEC on Medical Devices have been included in the Regulation on Medical Devices. 6

Market Surveillance activities for the medical devices are carried out by the Ministry of Health, Directorate General for Curative Services, Department of Biomedical Engineering Services. In addition to the Regulation on Medical Devices, following legislation is taken into consideration for market surveillance purposes in our country: numbered act - Regulation on the procedure of market surveillance activities carried out by Ministry of Health 7

Market Surveillance of Medical Devices : performed by following means: Notifications received from the natural and legal person, Notifications received from public bodies, Notifications received from public ( media, print media etc.), Notifications received from other countries vigilance systems, Risk evaluation etc. 8

CaseNumberRateAction Not in compliance with the legislation 3945,9 %Corrective actions have been taken In compliance with the legislation % Other %Giving up the business by the firm, wrong notification, cases which are under the responsibility of other institutions etc. 9

Thank you for your kind attention. 10