Growth

Contacts

Contacts

European Commission

National Competent Authorities

Contact points

Belgie / Belgique / Belgium

MDD AIMDD
Head of the Medical Device Unit : Vanessa Biname
Co-ordinator of MD Unit : Frédérique Meulders - tel:+32 2 524.83.22
Federal Agency for Medicines and Health Products Health Products Division
Place Victor Horta 40, boîte 40, B - 1060, Brussels, fax:+32 2 524.81.20
E-mail: meddev@fagg.be - Web site

IVDMD
Dr.Sc.Biol. Christel Van Campenhout
Dr. Anne Van Nerom, DVM
- tel:+32 2 642 55 40
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, fax:+32 2 642 56 45
E-mail: Christel.VanCampenhout@wiv-isp.be, Anne.VanNerom@wiv-isp.be - Web site

Bulgaria

Head of Department: Vessela Boudinova , Todor Darakchiev
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 34 83, fax:+359 2 890 34 34
E-mail: vessela.boudinova@bda.bg, darakchiev@bda.bg - Web site

Ceska Republika / Czech Republic

Katerina Pavlikova, Jakub Machalek
Ministry of Health Department of Pharmacy, Medical Devices Unit
Palackého náměstí 4, CZ - 12801 Prague 2, tel:+420 224 972422, +420 224 972385,
E-mail: medicaldevices@mzcr.cz - Web site

croatia flag Hrvatska / Croatia

Suzana Oštarčević
Agency for Medicinal products and medical devices
Ksaverska cesta 4, 10 000 Zagreb, tel: +385 1 4884 300, fax: +381 1 4884 110
E-mail: suzana.ostarcevic@halmed.hr- Web site

Danmark / Denmark

Kristine Rasmussen,
Danish Health and Medicines Authority,
Pharmacovigilance and Medical Devices
Axel Heides Gade 1, DK - 2300 - Kobenhavn, tel:+45 44 88 9667
E-mail: med-udstyr@dkma.dk, Web site

Deutschland / Germany

AIMDD, MDD, IVDMD Legislation
Susanne Conze
- tel:+ 49 228 941-3322, Dr. Matthias Neumann - tel:+49 228 941-2636
Federal Ministry of Health
Rochusstrasse 1, D - 53123 Bonn, fax:+ 49 228 941-4946
E-mail: mailto:medizinprodukte@bmg.bund.de - Web site

AIMDD, MDD, IVDMD Designating
Dr. Rainer Edelhaeuser
- tel:+49 228 97794-0, fax:+49 228 97794-44
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)
E-mail: zlg@zlg.nrw.de - Web site

AIMDD CA - Dr. Ekkehard Stößlein - tel:+49 228 207 5384
MDD CA - Dr. Karl Broich - tel:+49 228 207 5355
IVDMD CA - Dr. Rüdiger Siekmeier - tel:+49 228 207 5360
Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3, D - 53175 Bonn, fax:+49 228 207 5300
E-mail: medizinprodukte@bfarm.de - Web site

IVDMD CA - Dr. Markus Funk - tel:+49 6103 77 3115 Jochen Halbauer - tel:+49 6103 +77 3114
Paul Ehrlich Institute, Section Pharmacovigilance 2
Paul-Ehrlich-Strasse 51-59, D - 63225 Langen, fax:+49 6103 77 1268
E-mail: pharmacovigilance2@pei.de - Website

Eesti / Estonia

Health Board, Medical Devices Department
1a Põllu st., EE - Tartu 50303,
E-mail: MSO@terviseamet.ee - Web site

Ireland / Eire

Nial MacAleenan- tel:+353-1-6764971, fax:+353-1-6344033
Health Products Regulatory Authority
Kevin O’Malley House, Medical Devices Department, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: niall.macaleenan@hpra.ie - Web site

Ellada / Greece

Maria Perpiraki - tel:+30 21 06 50 74 07, fax:+30 21 06 50 74 50
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens, E-mail: perpiraki@eof.gr - Web site

España / Spain

Mrs. Carmen Abad - tel: +34918225274, fax: +34918225289
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES - 28022 Madrid
E-mail: sgps@aemps.es, Web site http://www.aemps.gob.es/

France

Dr. Jean-Claude Ghislain - tel:+33 1 55 87 4271 fax:+33 1 55 87 37 42
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mail: dedim.ugsv@ansm.sante.fr - Web site

Italia / Italy

Head of Unit 3 - Dr.Annamaria Donato - tel:+39 06 5994 3063, fax:+39 06 5994 3776
Head of Unit 4 - Dr. Pietro Calamea - tel:+39 06 5994 2669, fax:+39 06 5994 3266
Ministry of Health- Directorate General of Medical Devices and Pharmaceutical Services
via Giorgio Ribotta 5, IT - 00144 Roma,
E-mail: an.donato@sanita.it, p.calamea@sanita.it

Kypros / Kibris / Cyprus

Stelios Christofides - tel:+357 22 605572
Andrie Stylianou - tel:+357 22 605574
Cyprus Medical Devices Competent Authority
Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia, fax:+357 22 468427,
E-mail: cymda@mphs.moh.gov.cy

Latvija / Latvia

Deputy Director: Dace Ķikute - tel:+371 67078424
State Agency of Medicines
15 Jersikas street, LV - 1003 Riga
E-mail: Dace.kikute@zva.gov.lv, info@zva.gov.lv

Lietuva / Lithuania

Director: Nora Ribokiene - tel:+370 5 261 51 77, fax:+370 5 212 73 10
The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
Jeruzales str. 21, LT-08420 Vilnius
E-mail: vaspvt@vaspvt.gov.lt - Web site

Luxembourg

Ministère de la Santé, Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: meddevices@ms.etat.lu - Web site

Malta

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mt, Web site: http://mccaa.org.mt/

Magyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: p.bunyitai@enkk.hu , amd@enkk.hu

Nederland / Netherlands

Notification/Registration
CIBG Farmatec-BMC, Front Office -
tel: +31 70 340 6161 
Postal address: PO box 16114, NL - 2500 BC The Hague, Visitors address: Wijnhaven 16, NL - 2511 GA Den Haag
E-mail: Medische_hulpmiddelen@minvws.nl - Web site

Law Enforcement (a.o. vigilance and market surveillance)
Dutch Healthcare Inspectorate, IGZ information office (Meldpunt)
- tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Healthcare Inspectorate
Postal Address: P.O. Box 2680, NL - 3500BS Utrecht, Visitors address: Stadskantoor Utrecht, Stadsplateau 1, NL 3521 AZ Utrecht
E-mail: meldpunt@igz.nl - Web site

Österreich / Austria

Dr. Wolfgang Ecker - tel:+43 1 71100 4206
Dr. Martin Renhardt - tel:+43 1 711004487
Ing. Andreas Gutruf - tel:+43 1 711004602
Federal Ministry of Health
Dept. Pharmaceuticals and Medical Devices
Radetzkystrasse 2, 1030 Wien/Vienna
E-mail: meddev@bmgf.gv.at - Web site

Polska / Poland

Competent Authority
Andrzej Karczewicz - tel:+48 22 492 11 90
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, fax:+48 22 492 11 99
E-mail: incydenty@urpl.gov.pl - Web site

Legislation - Designation of NBs
Sebastian Migdalski -
tel: +48 22 6349324, fax:+48 22 8316557
Ministry of Health
Miodowa 15, PL - 00-952 Warsaw
E-mail: s.migdalski@mz.gov.pl, Web site

Portugal

Judite Neves, Pharm.D., Director of Health Products Directorate
Infarmed - National Authority of Medicines and Health Products, IP
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
tel: + 351 21 798 7100, tel:+351 21 798 7235, fax:+351 21 798 7316
E-mail: infarmed@infarmed.pt, daps@infarmed.pt - Web site

Romania

Lazar Iordache, tel: +40 21 222 8652
Margareta Mihalache - tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro margaretamihalache@ms.ro - web site: www.ms.ro

Slovenija / Slovenia

Marcia Elena Podboršek - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, marcia.podborsek@jazmp.si - Web site

Slovenska Republika / Slovakia

Dr. Marek Slávik - tel:+421 2 50701307
State Institute for Drug Control, Medical Devices Section
Kvetna 11, SK - 825 08 Bratislava 26,
E-mail: marek.slavik@sukl.sk - Web site

Suomi / Finland

Dr. Jussi Holmalahti, Director - tel:+358 9 772 920, fax:+358 9 772 2138
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki,
E-mail: Jussi.holmalahti@valvira.fi, kirjaamo@valvira.fi - Web site

Sverige / Sweden

Dr. Helena Dzojic
Medical Products Agency´ 'Läkemedelsverket'
Medical Devices
Box 26, SE-751 03 Uppsala, tel:+46 18 174600, fax:+46 18 503115
E-mail: meddev.central@mpa.se - Web site

United Kingdom

Ranulf Barman - tel:+44 203 080 6311, fax:+44 203 118 9808
Medicines & Healthcare products Regulatory Agency (MHRA)
Floor 4-O, Buckingham Palace Road - London SW1W 9SZ
E-mail: ranulf.barman@mhra.gsi.gov.uk - Web site

Norway / Norge

Ingeborg Hagerup-Jenssen, Bjørn Kristian Berge
Helsedirektoratet / Norwegian Directorate for Health
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, tel:+47 24 16 31 00 , fax:+47 24 16 30 21,
E-mail: meddev-no@helsedir.no - Web site

Iceland / Island

Haukur Eggertsson - tel:+354 520 2100, fax:+354 561 2170
Icelandic Medicines Agency
Vínlandsleið 14, IS-113 Reykjavík
E-mail: Haukur.Eggertsson@lyfjastofnun.is - Web site

Switzerland

Swissmedic, Swiss Agency for Therapeutic Products
Hallerstrasse 7, CH -3012 Bern 7,
E-mail: medical.devices@swissmedic.ch - Web site

Liechtenstein

Dr. Christina Zimmer, tel:+423 236 73 33, fax:+423 236 75 64
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: christina.zimmer@llv.li - info.ag@llv.li - Web site

Turkey

Hande TURAN, A.Volkan KELES - Tel: +90 312 2183072/73, Fax:+90 312 2183059
Ministry of Health
DG for Pharmaceuticals and Pharmacy
Department of Medical Device Services,
Market Surveillance Section
Mithatpasa Cad. No:3, Sihhiye 06434, Ankara/TÜRKIYE
E-mail: md.int@titck.gov.tr - Web site

Vigilance contact points

Belgie / Belgique / Belgium

MDD AIMDD
Head of Unit : Th. Roisin, S. Vanackere
AFMPS - Agence Fédérale des Medicaments et des Produits de Santé
Place Victor Horta 40, boîte 40, B - 1060, Brussels, tel:+32 2 524 8178 fax:+32 2 524 8120
E-mail: meddev@afmps.be - Web site

IVDMD
Dr. Anne Van Nerom, Jeroen Poels
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, tel:+32 2 642 5392, fax:+32 2 642 5645
E-mail: IVD@wiv-isp.be- Web site

Bulgaria

Head of Department: Vessela Boudinova , Todor Darakchiev
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 3483, fax:+359 2 890 3434
E-mail: vessela.boudinova@bda.bg, darakchiev@bda.bg - Web site

Ceska Republika / Czech Republic

Ivana Justová
State Institute for Drug Control
Šrobárova 48, 100 41 Prague 10, Czech Republic, tel: +420 272 185 794, fax: +420 272 185 764
E-mail: urgent@sukl.cz , ivana.justova@sukl.cz

croatia flagHrvatska / Croatia

Krunoslav Kranjcec,
Agency for Medicinal products and medical devices
Ksaverska cesta 4, 10 000 Zagreb, tel: +385 1 4884 327, fax: +381 1 4884 110
E-mail: medpro@halmed.hr, Krunoslav.kranjcec @halmed.hr - Web site

Danmark / Denmark

Danish Health and Medicines Authority
Axel Heides Gade 1, DK - 2300 - Kobenhavn, tel:+45 44 88 9595, fax:+45 44 88 9599
E-mail: med-udstyr@dkma.dk, Web sites: www.medicinskudstyr.dk, http://medicaldevices.dk/

Deutschland / Germany

AIMDD, MDD - Dr. Ekkehard Stößlein - tel:+49 228 207 5384
IVDMD - Prof. Dr. Rüdiger Siekmeier - tel:+49 228 207 5360
Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3, D - 53175 Bonn, fax:+49 228 207 5300
E-mail: medizinprodukte@bfarm.de - Web site

IVDMD
Dr. Markus Funk - tel:+49 6103 77 3115 Jochen Halbauer - tel:+49 6103 +77 3114
Paul Ehrlich Institute, Section Pharmacovigilance 2
Paul-Ehrlich-Strasse 51-59, D - 63225 Langen, fax:+49 6103 77 1268
E-mail: pharmacovigilance2@pei.de - Web site

Eesti / Estonia

Sofia Ratusnaja - tel:+372 744 7425
Health Board, Medical Devices Department
1a Põllu st., EE - Tartu 50303
E-mail: mso@terviseamet.ee - Web site

Ireland / Eire

Andrea Hanson, Anne Tobin - tel:+353 1 676 4971, fax:+353 1 634 4033
Health Products Regulatory Authority
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: devicesafety@hpra.ie - Web site

Ellada / Greece

Dr. George Aislaitner- tel:+30 213 20 40337, fax:+30 210 65 07585
E-mail: vigilancematerial@eof.gr,
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens

España / Spain

Carmen Abad
Carmen Valls - tel: +34 91 822 5255, fax: +34 91 822 5289
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES - 28022 Madrid
E-mail: psvigilancia@aemps.es - Web site

France

Emilie Alliez - tel:+33 1 55 87 33 46, fax:+33 1 55 87 37 02
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mails: Exclusively for correspondence between authorities:medicaldevicesvigilance@ansm.sante.fr
Other purposes: materiovigilance@ansm.sante.fr - Web site

Italia / Italy

Vigilance on Medical Devices
Dr. Rosaria Boldrini - tel: +39 06 5994 2381, fax:+39 06 5994 3812
E-mail: dgfdm@postacert.sanita.it, vigilance@sanita.it, r.boldrini@sanita.it
MDD AIMDD Vigilance - Dr. ssa Marcella Marletta - Dr.ssa Elena Giovani,
tel: +39 06 5994 2910, fax: +39 5994 3812
E-mail: dgfdm@postacert.sanita.it, vigilance@sanita.it , segr.dgfdm@sanita.it
IVDMD Vigilance - Dr. Pietro Calamea
tel: +39 06 5994 2669, fax: +39 06 5994 3266
E-mail: dgfdm@postacert.sanita.it, ivd@sanita.it, p.calamea@sanita.it
Ministry of HealthDirectorate General of Medical Devices and Pharmaceutical Services 
Via Giorgio Ribotta 5, IT - 00144 Roma

Kypros / Kibris / Cyprus

Stelios Christofides - tel:+357 22 605572
Andrie Stylianou - tel:+357 22 605574
Cyprus Medical Devices Competent Authority
Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia, fax:+357 22 468427
E-mail: cymda@mphs.moh.gov.cy

Latvija / Latvia

Daiga Lagzdina, Aivita Vanaga, Inese Vectirāne  - tel:+371 670 78466
State Agency of Medicines, Medical Devices Evaluation Department
15 Jersikas street, LV - 1003 Riga
E-mail: daiga.lagzdina@zva.gov.lv, Aivita.Vanaga@zva.gov.lv, inese.vectirane@zva.gov.lv

Lietuva / Lithuania

Jolanta Karavackaite, Julius Tertelis - tel:+370 5 261 5177, fax:+370 5 212 7310
The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
Zalgirio str. 92, LT- 09303 Vilnius
E-mail: julius.tertelis@vaspvt.gov.lt, jolanta.karavackaite@vaspvt.gov.lt, vaspvt@vaspvt.gov.lt - Web site

Luxembourg

MDD AIMD
Ministère de la Santé, Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: meddevices@ms.etat.lu  - Web site

IVD
Bureau de Contrôle de Qualité - tel: +352 2478 5632, fax: +352 40 0745
Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: Bcq@ms.etat.lu - Web site

Malta

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mt, Web site: http://mccaa.org.mt/

Magyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices,
1051, Budapest, Zrínyi street 3, Hungary
E-mail: vigilance@enkk.hu

Nederland / Netherlands

Esther Klinckenberg, Lindy van de Westelaken - tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Healthcare Inspectorate
Postal address: P.O. Box 2680, NL - 3500 BS Utrecht, Visitors address: St. Jacobsstraat 16, NL - 3511 BS Utrecht
E-mail: meldpunt@igz.nl - Web site

Österreich / Austria

Reinhard Berger - tel: +43 50555 36200, Christian Taylor - tel: +43 50555 36438
Federal Office for Safety in Healthcare - (BASG) Bundesamt für Sicherheit im Gesundheitswesen
Institute for Surveillance, Department Medical Devices Surveillance
Traisengasse 5, A-1200 Vienna, fax: +43 50555 36409
E-mail: medizinprodukte@basg.gv.at, - Web site

Polska / Poland

Competent Authority
Andrzej Karczewicz - tel:+48 22 492 11 90, Beata Koziozemska - tel: +48 22 492 11 68
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, fax:+48 22 492 11 99
E-mail: incydenty@urpl.gov.pl - Web site

Portugal - Vigilance

Raquel Alves - tel: + 351 21 798 7297, tel:+351 21 798 7145, fax:+351 21 798 7367
Infarmed - National Authority of Medicines and Health Products, IP Unidade de Vigilância de Produtos de Saúde
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
E-mail: dvps@infarmed.pt - Web site

Romania

Margareta Mihalache - tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro; margaretamihalache@ms.ro - web site: www.ms.ro

Slovenija / Slovenia

Marcia Elena Podboršek - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, marcia.podborsek@jazmp.si - Web site

Slovenska Republika / Slovakia

Darina Kaminská - tel:+421 2 50701215,
State Institute for Drug Control, Medical Devices Section
Kvetna 11, SK - 825 08 Bratislava 26
E-mail: darina.kaminska@sukl.sk - Web site

Suomi / Finland

Hannu Seitsonen - tel:+358 9 772 920, fax:+358 9 772 2155
Jari Knuuttila - tel:+358 5 0563 8532
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki
E-mail: laitevaarat@valvira.fi - Web site

Sverige / Sweden

Arne Kardell - tel:+46 18 174600, fax:+46 18 503115
Medical Products Agency´ 'Läkemedelsverket' Medical Devices
Box 26, SE-751 03 Uppsala
E-mail: meddev.central@mpa.se - Web site

United Kingdom

Tony Sant - tel:+44 20 3080 7080, fax:+44 203 118 9814
MHRA Devices
151 Buckingham Palace Road- London SW1W 9SZ
E-mail: aic@mhra.gsi.gov.uk - Web site

Norway / Norge

AIMDD, MDD IVDMD - – Raymond Ludvigsen / Bjørn Kristian Berge
Helsedirektoratet / Norwegian Directorate for Health
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, tel:+47 24 16 3000, fax:+47 24 16 3021,
E-mail: meddev-no@helsedir.no - Web site

Iceland / Island

Haukur Eggertsson - tel:+354 520 2100, fax:+354 561 2170
Icelandic Medicines Agency
Vínlandsleið 14, IS-113 Reykjavík
E-mail: Haukur.Eggertsson@lyfjastofnun.is - Web site

Switzerland

Swissmedic, Swiss Agency for Therapeutical Products
Medical Devices Division
Hallerstrasse 7, CH -3012 Bern
E-mail: materiovigilance@swissmedic.ch - Web site

Liechtenstein

Dr. Christina Zimmer - tel:+423 236 7333, fax:+423 236 7564
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: christina.zimmer@llv.li - info.ag@llv.li - Web site

Turkey

Hande Turan, Adem Ünal, A.Volkan Keles - tel:+90 312 218 30 71/72/73, fax:+90 312 218 30 59
T.C. Saglik Bakanligi, Ilaç ve Eczacilik Genel Müdürlügü,
Tibbi Cihaz Hizmetleri Dairesi Baskanligi, Piyasa Gözetimi ve Denetimi Subesi

Ministry of Health, DG for Pharmaceuticals and Pharmacy
Department of Medical Device Services, Market Surveillance Section
Mithatpasa Caddesi No:3, Sihhiye 06434, ANKARA - TURKEY
E-mail: md.int@titck.gov.tr - Web site

Clinical Investigation contact points

Belgie / Belgique / BelgiumBelgie / Belgique / Belgium

MDD AIMDD
Greet Musch, Steve Eglem
Federal Agency for Medicines and Health Products
Place Victor Horta 40, boîte 40, B - 1060, Brussels, tel:+32 2 524 8113 fax:+32 2 524 8120
E-mail: greet.musch@fagg.be, steve.eglem@fagg.be

IVDMD
Dr. Anne Van Nerom,
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, tel:+32 2 642 5040, fax:+32 2 642 5645
E-mail: Anne.VanNerom@wiv-isp.be,

BulgariaBulgaria

Todor Darakchiev - tel:+359 2 890 3483
Iskra Ivanova - tel +359 2 890 35 11 - Fax: +359 2 890 34 34
Bulgarian Drug Agency - Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia,
E-mail: todor.darakchiev@bda.bg - iskra.ivanova@bda.bg

Ceska RepublikaCeska Republika / Czech Republic

Irena Víchová - tel:+420 272 185701, fax:+420 272 15764
State Institute for Drug Control
Šrobárova 48, 100 41 Prague 10
E-mail: zp@sukl.cz

HrvatskaHrvatska / Croatia

Suzana Oštarčević,
Agency for Medicinal products and medical devices
Ksaverska cesta 4, 10 000 Zagreb, tel: ++385 1 4884 300
E-mail: Suzana.ostarcevic@halmed.hr

DanmarkDanmark / Denmark

Inger Eva Küne - tel:+45 72 22 74 00, fax:+45 44 88 9599
Danish Health and Medicines Autority
Axel Heides Gade 1, DK - 2300 - Kobenhavn
E-mail: med-udstyr@dkma.dk

DeutschlandDeutschland / Germany

Dr. Wolfgang Lauer - tel:+49 228 207 5355, fax:+49 228 207 5300
Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3, D - 53175 Bonn
E-mail: medizinprodukte@bfarm.de

Eesti / Estonia

Tagne Ratassepp - tel:+372 744 7409, fax:+372 744 7408
Health Board, Medical Devices Department
1a Põllu st., EE - Tartu 50303
E-mail: MSO@terviseamet.ee

EireIreland / Eire

Niall MacAleenan - tel:+353 1 676 4971, fax:+353 1 676 7836
Health Products Regulatory Authority
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: hpradevices@hpra.ie - Web site

ElladaEllada / Greece

Dr. Fotini Tzavella - tel:+30 210 65 07546, fax:+30 210 65 07585
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens
E-mail: ftzavella@eof.gr

EspañaEspaña / Spain

Mª Concepción Rodríguez Mateos - tel: +34 91 822 5270, fax: +34 91 822 5289
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES - 28022 Madrid
E-mail: psinvclinic@aemps.es - Web site

FranceFrance

Dr. Catherine Raveau-Landon - tel:+33 1 55 873687 fax:+33 1 55 873717
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mail: catherine.raveau-landon@ansm.sante.fr

ItaliaItalia / Italy

Dr. Antonio Parisi, Adele Misticoni Consorti - tel:+39 06 5994 225/2886, fax:+39 06 5994 3776
Ministry of Health, Department of Innovation- Directorate General of Medical Devices and Pharmaceutical Services
Via Giorgio Ribotta 5, IT - 00144 Roma
E-mail: dgfdm@postacert.sanita.it, a.parisi@sanita.it, a.misticoniconsorti@sanita.it

KyprosKypros / Kibris / Cyprus

Christiana Valianti - tel:+357 22 605574, fax:+357 22 468427
Cyprus Medical Devices Competent Authority
Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia,
E-mail: cymda@mphs.moh.gov.cy

LatvijaLatvija / Latvia

Andis Vilums - tel: +371 6707466, fax: +371 67078428
State Agency of Medicines, Department of Medical Devices Assessment
15 Jersikas Str. Riga, LV-1003
E-mail: andis.vilums@zva.gov.lv

LietuvaLietuva / Lithuania

Julius Tertelis - tel:+370 5 261 5177, fax:+370 5 212 7310
The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
Jeruzalès str. 21, LT- 08420 Vilnius
E-mail: julius.tertelis@vaspvt.gov.lt, vaspvt@vaspvt.gov.lt

LuxembourgLuxembourg

Direction de la Santé
Villa Louvigny / allée Marconi, L-2120 Luxembourg
E-mail:  meddevices@ms.etat.lu

MaltaMalta

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mt, Web site: http://mccaa.org.mt/

MagyarorszagMagyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: vigilance@enkk.hu

NederlandNederland / Netherlands

MDD - AIMD: Dr. P.W. Riem Vis - tel:+31 70 304 1694, fax:+31 70 304 1570
IVD: dr. ing. Kees Maquelin
Dutch Healthcare Inspectorate (DHCI) IGZ Loket
Postal address: P.O. Box 2680, NL - 3500 BS Utrecht, Visitors address: St. Jacobstraat 16, NL - 3511 BS Utrecht
E-mail: meldpunt@igz.nl

ÖsterreichÖsterreich / Austria

Dipl.-Ing. Dr. Ronald Bauer - tel:+43 50 555 36420, fax:+43 50 555 36409
Head of Department Clinical Trials
BASG - Bundesamt für Sicherheit im Gesundheitswesen
AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Institute Surveillance
Traisengasse 5
A-1200 Wien | Vienna
E-mail: ronald.bauer@ages.at

PolskaPolska / Poland

Andrzej Karczewicz - tel: +48 22 492 11 90, Beata Koziożemska - tel: +48 22 492 11 68
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, fax:+48 22 492 11 99
E-mail: incydenty@urpl.gov.pl

Portugal - Vigilance

Judite Neves, - tel: + 351 21 798 7235/7293/7294, fax:+351 21 798 7281
Infarmed - National Authority of Medicines and Health Products, IP Health Products Directorate
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
E-mail: daps@infarmed.pt

RomaniaRomania

Margareta Mihalache - tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro margaretamihalache@ms.ro - web site: www.ms.ro

SlovenijaSlovenija / Slovenia

Marcia Elena Podboršek - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, marcia.podborsek@jazmp.si - Web site

Slovenska RepublikaSlovenska Republika / Slovakia

Marek Slávik - tel: +421 2 50701307
State Institute for Drug Control, Medical Devices Section
Kvetná 11, SK-825 08 Bratislava 26
E-mail: marek.slavik@sukl.sk

SuomiSuomi / Finland

Kimmo Linnavuori - tel:+358 295 209 511, fax:+358 295 209 702
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki
E-mail: kimmo.linnavuori@valvira.fi

SverigeSverige / Sweden

Vendela Schnittger - tel:+46 18 174600, fax:+46 18 503115
Medical Products Agency 'Läkemedelsverket' Medical Devices
Box 26, SE-751 03 Uppsala
E-mail: meddevcentral@mpa.se

United KingdomUnited Kingdom

Daniella Smolenska - tel:+44 20 3080 7363, fax:+44 203 118 9808
Medicines & Healthcare products Regulatory Agency (MHRA)
4 Yellow, 151 Buckingham Palace Road- London SW1W 9SZ
E-mail: daniella.smolenska@mhra.gsi.gov.uk - Web site

NorgeNorway / Norge

Anne-Mari Håkelien / Ingeborg Hagerup-Jenssen - tel:+47 24 16 30 00
Helsedirektoratet / Norwegian Directorate of Health
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, 3105
E-mail: meddev-no@helsedir.no

IslandIceland / Island

Haukur Eggertsson - tel:+354 520 2100, fax:+354 561 2170
Icelandic Medicines Agency
Vínlandsleið 14, IS-113 Reykjavík
E-mail: Haukur.Eggertsson@lyfjastofnun.is - Web site

SwitzerlandSwitzerland

Swissmedic Medical Devices Division
Hallerstrasse 7, CH -3000 Bern 9
E-mail: clinicaltrials.devices@swissmedic.ch

LiechtensteinLiechtenstein

Dr. Christina Zimmer - tel:+423 236 7336, fax:+423 236 7564
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: christina.zimmer@llv.li - info.ag@llv.li - Web site

TurkeyTurkey

Cihad Göker
Ministry of Health, General Directorate of Pharmaceuticals and Pharmacy
Soğutozu Mah. 2176. Sok. No.5, Kat: 10 06520 Cankaya / ANKARA / TURKEY
Tel: +90 312 2183083
E-mail: cihad.goker@titck.gov.tr

TSE-BSE contact points (93 kB)

Other contact points

Share