|
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.fagg.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 Dimitrov
Mrs. 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
|
web site: under
construction |
+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 |
+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 |
+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.nam.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 |
www.eof.gr |
+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 |
http://www.eekh.hu |
+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 |
+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
|
|
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 |
|
+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 |
|
+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 |
+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/ |
+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 |
+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 |
+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 |
|
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
|
|
+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
CAKMAK
Mr. Seyhan SEN |
mehtap.cakmak@saglik.gov.tr
seyhan.sen@saglik.gov.tr |
www.saglik.gov.tr |
+ 90 312 431 09 90 |
|
|
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 |
