País | Directiva | Nombre
Dirección | Contacto | E-mail | Web | Teléfono | Fax |
Austria | AIMDD | Federal Ministry of Health Dept. Pharmaceuticals and Medical Devices Radetzkystrasse 2;
A-1030 Vienna Austria | Dr. Wolfgang Ecker
Dr. Martin Renhardt
Ing. Andreas Gutruf | meddev@bmgf.gv.at | www.bmgf.gv.at | +43 1 711 00 42 06
+43 1 711 00 44 87
+43 1 711 00 46 02 (Secretariat) | +43 1 7134404 2183 |
MDD |
IVDMD |
Belgium | AIMDD | Federal Agency for Medicines and Health Products Eurostation II
Place Victor Horta 40 b40
B-1060 Brussels
Belgium | Head of the Medical Device Unit :
Mr Wim Penninckx
Co-ordinator of MD Unit : Mrs. Frédérique Meulders
| meddev@fagg.be | www.health.fgov.be | +32 2 52 48322
(Frédérique Meulders) | +32 2 52 48120 |
MDD |
IVDMD | Scientific Institute Public Health
Department of Clinical Biology
J. Wytsmanstraat, 14
B-1050 Brussels
Belgium | Dr. Pharm. Jean-Claude Libeer | jean-claude.libeer@
iph.fgov.be | website CA IVD-BE | +32 2 642 55 40 | +32 2 642 56 45 |
Dr. Anne Van Nerom, DVM | anne.vannerom@
iph.fgov.be |
Bulgaria
| AIMDD | Bulgarian Drug Agency Office for Medical devices
26 Yanko Sakazov Blvd.
BG-1504 Sofia
Bulgaria | Head of Department:
Dr. Lyubomir DimitrovMrs. Rumena Kamburova Mr. Todor Darakchiev | | www.bda.bg | +359 2 946 1374 | +359 2 943 44 87 |
MDD |
IVDMD |
Cyprus
| AIMDD | Cyprus Medical Devices Competent AuthorityProdromou 1 & Chilonos 17 Corner
1449 Nicosia
Cyprus | Dr. Stelios Christofides Andrie Stylianou | cymda@mphs.moh.gov.cy
| www.moh.gov.cy/moh/moh.nsf/All/4842763027B99BB0C225732B0037D278?Opendocument | +357 22 605 572 +357 22 605 574 | +357 22 468 467
|
MDD |
IVDMD |
Czech Republic
| AIMDD | Ministry of Health
Palackého náměstí 4 128 01 Prague 2 Czech Republic | Mrs. Danuše Drahotová Mr. Pavel Sroub | danuse.drahotova@mzcr.cz pavel.sroub@mzcr.cz | http://www.mzcr.cz/Odbornik/
Categories/4-zdravotnicke-prostredky.html www.sukl.eu/modules/marwel/index.php?rewrite=pharmaceutical-industry/medical-devices-1&lang=2 | +420 224 972 735 | +420 224 916 002 |
MDD | +420 224 972 738 |
IVDMD | +420 224 972 363 |
Denmark | AIMDD | The Danish Medicines Agency Axel Heides Gade 1 DK-2300 København S Denmark | Mrs Ellen Jespersen Mr Hans-Kristian Andersen | med-udstyr@dkma.dk | www.medicinskudstyr.dk www.medicaldevices.dk/1024/forside.uk.mu.aspartikelID=3863
| +45 44 88 95 95 | +45 44 88 95 99 |
MDD |
IVDMD |
Estonia
| AIMDD | State Agency of Medicines Medical Devices Department 1 Nooruse st., 50411 Tartu Estonia | Dr. Andrei Knuut | info@ravimiamet.ee
(common) | www.ravimiamet.ee | +37 27 37 41 40 (common) | +37 27 37 41 42 (common) |
| MDD |
| IVDMD |
Finland | AIMDD | National Agency for Medicines, Medical Devices P.O. Box 55, Mannerheimintie 103b,
FI-00301 Helsinki | Prof. Tomi Kauppinen
Head of Department
| firstname.surname@
nam.fi | www.fimea.fi | +358 9 4733 4241 | +358 9 4733 4266 |
MDD |
IVDMD |
France | AIMDD | Agence francaise de séurité sanitaire des produits de santé (AFSSAPS) 143-147 boulevard Anatole France 93285 Saint Denis Cedex France | Dr. Jean-Claude Ghislain | dedim.ugsv@ afssaps.sante.fr | www.afssaps.fr | +33 1 55 87 37 45 | +33 1 55 87 37 42 |
MDD |
IVDMD |
Germany | AIMDD Legislation | Federal Ministry of Health
Am Propsthof 78a D-53123 Bonn Germany | Mr. Wilfried Reischl
Dr. Matthias Neumann | medizinprodukte@
bmgs.bund.de | www.bmgs.bund.de | + 49(0) 228 941-1180
(W. Reischl)
+ 49(0) 228 941-2636
(Dr. M. Neumann) | + 49 228 941-4946 |
AIMDD Designating | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Germany | Dr. Rainer Edelhaeuser | zlg@zlg.nrw.de | www.zlg.de | + 49 228 97794-0 | + 49 228 97794-44 |
AIMDD CA | Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3 D53175 Bonn Germany | Dr. Ekkehard Stößlein | medizinprodukte@
bfarm.de | www.bfarm.de | +49 228 207 5384 | + 49 228 207 5300 |
MDD Legislation | Federal Ministry of Health
Am Propsthof 78a D-53123 Bonn Germany | Mr. Wilfried Reischl
Dr. Matthias Neumann | medizinprodukte@
bmgs.bund.de | www.bmgs.
bund.de | + 49(0) 228 941-1180 (W. Reischl)
+ 49(0) 228 941-2636
(Dr. Neumann) | + 49 228 941-4946 |
MDD Designating | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Germany | Dr. Rainer Edelhaeuser | zlg@zlg.nrw.de | www.zlg.de | + 49 228 97794-0 | + 49 228 97794-44 |
MDD CA | Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3 D53175 Bonn Germany | Dr. Dirk Wetzel | medizinprodukte@
bfarm.de | www.bfarm.de | +49 228 207 5235 | +49 228 207 5300 |
IVDMD Legislation | Federal Ministry of Health
Am Propsthof 78a D-53123 Bonn Germany | Mr. Wilfried Reischl
Dr. Matthias Neumann | medizinprodukte@
bmgs.bund.de | www.bmgs.
bund.de | + 49(0) 228 941-1180
(W. Reischl)
+ 49(0) 228 941-2636
(Dr. Neumann) | + 49 228 941-4946 |
IVDMD Designating | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Germany | Dr. Rainer Edelhaeuser | zlg@zlg.nrw.de | www.zlg.de | + 49 228 97794-0 | + 49 228 97794-44 |
IVDMD1
CA | Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3 D53175 Bonn
Germany 1 ex those Annex II devices | Dr. Rüdiger Siekmeier | medizinprodukte@
bfarm.de | www.bfarm.de | + 49 228 207 5360 | + 49 228 207 5300 |
IVDMD2
CA | P aul Ehrlich Institute
Section Pharmacovigilance 2
Paul-Ehrlich-Strasse 51-59
D-63225 Langen
Germany 2 Annex II products as far as related to infection diseases or immuno haematology or tissue typing | Dr.. Markus Funk Jochen Halbauer | pharmacovigilance2@pei.de | www.pei.de | +49- 6103 77 3115
(Dr. Funk) or
77 3114
(J. Halbauer) | +49- 6103 77 1268 |
Greece | AIMDD | National Organization for Medicines 284 Mesogion Ave 155 62 Holargos-Athens Greece | Mrs. Maria Perpiraki Mrs. Virginia Safra | perpiraki@eof.gr vsafra@eof.gr | eof1.eof.gr/eof_en/enhome.html | +30 21 06 50 74 07 +30 21 06 50 73 24 | +30 21 06 50 74 50 |
MDD |
IVDMD |
Hungary
| AIMDD | Authority for Medical Devices Budapest 1245 Pf. 987. Hungary | Mr. Peter Bunyitai | amd@eekh.hu | www.eekh.hu/en/index.php?option=com_content&task=blogcategory&id=14&Itemid=28 | +36 1 302 5060 | +36 1 269 1255 |
MDD |
IVDMD |
Iceland
(EFTA) | AIMDD | Directorate of Health Austurstrond 5, IS-170 Seltjarnarnes Iceland | Mrs. Anna Bjorg Aradottir | annabara@landlaeknir.is | www.land
laeknir.is | +354 510 1900/1905 | +354 510 1919 |
MDD |
IVDMD |
Ireland | AIMDD | IIrish Medicines Board.Kevin O’Malley House Medical Devices Department Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland | Ms. Ann O'Connor
| medicaldevices@imb.ie | www.imb.ie/EN/medical-Devices.aspx | +353-1-6764971 | +353-1-6344033 |
MDD |
IVDMD |
Italy | AIMDD | Ministry of Labour, Health and Social Affairs, Department of Innovation Directorate General of Medicine and Medical Devices via Giorgio Ribotta 5, 00144 Roma Italy | MD and AIMD Head of Unit 3 Dr.Annamaria Donato IVDMD Head of Unit 4 Dr.Giovanna Nisticò | an.donato@sanita.it g.nistico@sanita.it | www.salute.gov.it | 0039 06 5994 3809 0039 06 5994 3390 | 0039 06 5994 3292 0039 06 5994 3266 |
MDD |
IVDMD |
Latvia | AIMDD | Health Statistics and Medical Technologies State Agency
Medical Devices Board for Latvia 12/22 Duntes street,Riga, Latvia, LV-1005 | Mr. Egils
Lavendelis | agentura@vsmtva.gov.lv | www.zva.gov.lv | +371 67 501593 | +371 67 501591 |
MDD |
IVDMD |
Liechenstein
(EFTA) | AIMDD | Amt für Gesundheit
Äulestrasse 51
Postfach 684
FL-9490 Vaduz
Liechenstein | R. Kieber | reto.kieber@ag.llv.li | www.llv.li | +423 236 66 33 | +423 236 75 64 |
MDD |
IVDMD |
Lithuania
| AIMDD | The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania Zalgirio str. 92 LT- 09303 Vilnius Lithuania | Director:
Prof. Juozas Galdikas | juozas.galdikas@vaspvt.gov.lt Common email: vaspvt@vaspvt.gov.lt | www.vaspvt.gov.lt www.vvkt.lt | +370 5 261 51 77 | +370 5 212 73 10 |
MDD |
IVDMD |
Luxembourg | AIMDD | Ministère de la Santé - Direction de la Santé
Villa Louvigny - allée Marconi
L-2120 Luxembourg | Dr Gérard Scharll | gerard.scharll@
ms.etat.lu | www.etat.lu/MS/ www.ms.public.lu/fr/ | +352 478 56 34 | +352 26 20 32 96 |
MDD |
IVDMD |
Malta
| AIMDD | Malta Standards Authority Second Floor,
Evans Building,
Merchants Street,
Valletta VLT 1179 Malta | Dr. David Pulis Dr. Tristan Camilleri | david.pulis@msa.org.mt tristan-charles.camilleri@msa.org.mt | www.msa.org.mt | +356 2395 2000 | +356 2124 2406 |
MDD |
IVDMD |
Netherlands | AIMDD MDD IVDMD | Vigilance
Dutch Healthcare Inspectorate
Postal address:
P.O. Box 2680
3500 BS Utrecht
The Netherlands
Visitors address:
St. Jacobstraat 16
3511 BS Utrecht
The Netherlands | Mr. Jan Moleveld Mr. Jan Moleveld Ms. Laura de Vries | loket@igz.nl | www.igz.nl | +31 88 120 5000 | +31 88 120 5001 |
AIMDD MDD IVDMD | Notification/Registration
CIBG
Farmatec-BMC Postal address:
PO box 16114
2500 BC
The Hague
The Netherlands Visitors address:
Wijnhaven 16
2511 GA Den Haag
The Netherlands | Ms. Joan Deckers PhD | Medische_hulpmiddelen@minvws.nl | www.farmatec.nl | +31 70 340 5200 | +31 70 340 7426 |
Norway
(EFTA) | AIMDD | Directorate of Health P.O.Box 7000 ST. Olavs plass N-0130 Oslo Norway | Mrs. Ingeborg Hagerup-Jenssen
Mr. Bjørn Kristian Berge | meddev-no@shdir.no | www.shdir.no www.helsedirektorate.no | +47 810 20 050 | +47 24 16 30 21 |
MDD |
IVDMD | Mrs. Sissel Dyrnes |
Poland | MDD
AIMD
IVDMD | Legislation
Designation of NBs
Ministry of Health
Miodowa 15
00-952 Warsaw
Poland | Mr. Sebastian Migdalski | s.migdalski@mz.gov.pl | www.mz.gov.pl | +48 22 6349324 | +48 22 8316557 |
MDD
AIMD
IVDMD | Competent Authority
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Zabkowska 41
03 – 736 Warsaw
Poland | Mrs.Joanna Kilkowska Mr. Andrzej Karczewicz | joanna.kilkowska@urpl.gov.pl andrzej.karczewicz@urpl.gov.pl | www.urpl.gov.pl www.en.urpl.gov.pl | +48 22 4921170 +48 22 4921190 | +48 22 4921199 +48 22 4921199 |
Portugal | AIMDD | Infarmed National Authority of Medicines and Health Products, IP
Parque de Saude de Lisboa Av. do Brasil, n. 53 1749-004 Lisboa Portugal | Mrs. Judite Neves, Pharm.D., Director of Health Products Directorate | infarmed@infarmed.pt daps@infarmed.pt | www.infarmed.pt | + 351 21 798 7100 351 21 798 7235 | + 351 21 798 7316 + 351 21 798 7281 |
MDD |
IVDMD |
Romania | AIMDD | Ministry of Health 1-3, Cristian Popisteanu Street, Sector 1 010024, Bucharest Romania | Mrs. Ana Tanase | atanase@ms.ro | www.ms.ro | +40 21 307 25 81 | +40 21 307 25 85 |
MDD |
IVDMD |
Russia | AIMDD | Federal Service on surveillance in healthcare and social development of Russian Federation (Roszdavnadzor) | | | www.roszdravnadzor.ru | | |
MDD |
IVDMD |
Slovenia
| AIMDD | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Ptujska ulica 21 SI-1000 Ljubljana Slovenia | Dr. Petra Marinko | meddev@jazmp.si petra.marinko@jazmp.si | www.jazmp.si | +386 (0)8 2000 500 | +386 (0)8 2000 510 or +386 (0)8 2000 557 |
MDD |
IVDMD |
Slovakia
| AIMDD | State Institute for Drug Control Medical Devices Section
Kvetna 11, 825 08 Bratislava 26 Slovakia | Mr. Marek Slávik | slavik@sukl.sk | www.sukl.sk/en?page_id=256 | +421 2 50701307 | +421 2 55565151 |
MDD |
IVDMD |
Spain | AIMDD | Ministerio Sanidad y Consumo
Agencia Espaňola de Medicamentos y Productos Sanitarios
Parque Empresarial Las Mercedes.
Edificio 8. C/ Campezo 1
28022 Madrid
Spain | Mrs. Carmen Abad | sgps@agemed.es | www.msc.es www.agemed.es | +34918225261 | +34918225289 |
MDD |
IVDMD |
Sweden | AIMDD | Medical Products Agency Medical Devices Box 26 SE-751 03 Uppsala Sweden | Dr. Lennart Philipson Mr. Lars Johansson | meddev.central@mpa.se | http://www.lakemedelsverket.se/ | +46 18 17 46 00 | +46 18 50 31 15 |
MDD |
IVDMD |
Switzerland
(EFTA) | AIMDD MDD | Swissmedic Medical Devices Division Erlachstr. 8 CH 3000 Bern 9 Switzerland | Mrs. Margit Widmann | margit.widmann@swissmedic.ch materiovigilance@swissmedic.ch | www.swissmedic.ch/md.asp | +41 31 323 22 51 | +41 31 322 76 46 |
IVDMD | Mr. Andreas Schlegel | andreas.schlegel@swissmedic.ch materiovigilance@swissmedic.ch |
Turkey
(Candidate) | AIMDD MDD IVDMD | Ministry of Health General Directorate of the Curative Services
Biomedical Engineering Department
Market Surveillance Unit Atatürk Bulvarı No: 657. Kat Sıhhiye 06343 Ankara/TURKEY | Mrs. Mehtap
CAKMAKMr. Seyhan SEN | mehtap.cakmak@saglik.gov.tr seyhan.sen@saglik.gov.tr | www.saglik.gov.tr | + 90 312 431 09 90 | |
Ukraine | AIMDD MDD IVDMD | Ministry of Public Health | | | www.moz.gov.ua/ua/portal/ | | |
United Kingdom | AIMDD MDD IVDMD | Medicines and Healthcare products Regulatory Agency (MHRA) 8th Floor
Market Towers
1 Nine Elms Road
London SW8 6NQ United Kingdom | Mr. Steve Owen | steve.owen@mhra.gsi.gov.uk | www.mhra.
gov.uk | + 44 (0) 20 7084 3184 | + 44 (0) 20 7084 3112 |
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) 
