I listed below the national surveillance authorities per countries. This is specific to Medical Devices.
The list for with the other industry can be find here.
INDEX
Austria
Federal Ministry of Health – Dept. Pharmaceuticals and Medical Devices
Radetzkystrasse 2, 1030 Wien/Vienna
e-mail: meddev@bmgf.gv.at
Federal Office for Safety in Health Care
Traisengasse 5, 1200 Vienna, Austria
Tel: +43 50 555 36402
e-mail: medizinproduckte@basg.gv.at
Website: www.basg.gv.at
Belgium
Federal Agency for Nuclear Control
Health Protection Unit
Rue Ravenstein 36, 1000 Brussels
Tel: +32 2 289 21 11 – Fax : +32 2 289 21 12
e-mail: pointcontact@fanc.fgov.be
Website: www.afcn.fgov.be
Federal Agency for Medicines and Health Products
Health Products Division
Place Victor Horta 40/40, 1060 Brussels
Tel: +32 2 524 80 00 – Fax: +32 2 524 81 20
e-mail: meddev@afmps.be
Website: www.fagg-afmps.be
Bulgaria
Bulgarian Drug Agency
Department Control of Medicinal Products and Medical devices
8, Damyan Gruev Str., 1303 Sofia, Bulgaria
Tel: +359 2 890 34 83 – Fax:+359 2 890 34 34
e-mail: bda@bda.bg
Website: www.bda.bg
Croatia
Ministry of Health, Health Protection Directorate
Ksaver 200a, 10000 Zagreb, Croatia
Tel: +385 1 4607555, Fax: +385 1 4677076
Website: www.zdravlje.hr
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: halmed@halmed.hr
Website: www.halmed.hr
Cyprus
Ministry of Health
Cyprus Medical Devices Competent Authority
1 Prodromou & 17 Chilonos Street, 1448 Nicosia, Cyprus
Tel: +357 22605572/735 – Fax: +357 22468427
e-mail: cymda@mphs.moh.gov.cy
Website: www.moh.gov.cy/mphs
Czech Republic
State Institute for Drug Control
Šrobárova 48, 100 41 Praha 10,
Tel: +420 272 185 111
e-mail: posta@sukl.cz
Denmark
Danish Health and Medicines Authority
Axel Heides Gade 1 DK-2300 Copenhagen S
Tel: +45 72 22 74 00 – Fax: +45 44 88 95 99
e-mail: med-udstyr@dkma.dk; dkma@dkma.dk
Website: www.medicinskudstyr.dk
Estonia
Health Board, Medical Devices Department
1a Põllu st., EE – Tartu 50303,
E-mail: MSO@terviseamet.ee
Website: www.terviseamet.ee
Finland
National Supervisory Authority for Welfare and Health (Valvira)
Mannerheimintie 103 b, P.O. Box 210, FI-00281 Helsinki, Finland
Tel: +358 295 209 111
Website: www.valvira.fi
France
Ministry of the Economy and Finances
Direction générale de la concurrence, de la consommation et de la répression des fraudes – Unit 5B
Télédoc 241 – 59, boulevard Vincent-Auriol F-75703 Paris Cedex 13
Tel: +33 1 44 97 28 01
e-mail: Bureau-5B@dgccrf.finances.gouv.fr
Website: www.economie.gouv.fr/dgccrf
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143/147, boulevard Anatole France 93285 SAINT-DENIS CEDEX
Tel : +33 1 55 87 36 86 / +33 1 55 87 37 28
e-mail: dmdpt@ansm.sante.fr , dmtcos@ansm.sante.fr
Website: www.ansm.sante.fr
Direction Générale des douanes et droits indirects
Tel : 0811 20 44 44 / +33 1 72 40 78 50
e-mail: ids@douane.finances.gouv.fr
Website: www.douane.gouv.fr
Germany
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
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)
e-mail: zlg@zlg.nrw.de
Federal Ministry of Health
Rochusstrasse 1, D – 53123 Bonn
Fax:+ 49 228 941-4946
e-mail: medizinprodukte@bmg.bund.de
Greece
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens
e-mail: relation@eof.gr
Website: www.eof.gr
Hungary
Health Registration and Training Center (HRTC)
H-1085 Budapest, Horánszky street 15
Tel : +36 1 302 5060 , Fax : +36 1 269 1255
E-mail: amd@enkk.hu
Website: www.enkk.hu
Iceland
Medicines Agency
Vínlandsleið 14, 113 Reykjavík
Tel: 520 2100 – Fax: 561 2170
e-mail: ima@ima.is
Website: www.imas.is
Ireland
Health Products Regulatory Authority (HPRA)
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
Tel: +353 1 676 4971
e-mail: info@hpra.ie
Website: www.hpra.ie
Italy
Ministry of Health, Department of Planning and Organisation of the National Health Service – Directorate
General of Medical Devices, pharmaceutical services, and safety in healthcare
via Giorgio Ribotta 5, IT – 00144 Roma
e-mail: segr.dgfdm@sanita.it
Website: www.sanita.it
Latvia
Health Inspectorate
Klijanu Street 7, Riga, LV — 1012, Latvia
Tel: 371-67819671 – Mob: 371-26315189 – Fax: 371-67819672
e-mail: vi@vi.gov.lv
Website: www.vi.gov.lv
Liechtenstein
Amt für Gesundheit
Äulestrasse 51, Postfach 684, 9490 Vaduz, Liechtenstein
e-mail: info.ag@llv.li
Website: www.ag.llv.li
Lithuania
State Health Care Accreditation Agency
Jeruzales st. 21 LT-08420 Vilnius Lithuania
Tel: (85) 261 5177 – Fax: (85) 212 7310
e-mail: vaspvt@vaspvt.gov.lt
Website: www.vaspvt.gov.lt
Luxembourg
Ministère de la Santé
Villa Louvigny – Allée Marconi L-2120 Luxembourg
Tel: +352 24785500
e-mail: info@ms.public.lu
Malta
Malta Competition and Consumer Affairs Authority
Technical Regulations Division – Market Surveillance Directorate
Mizzi House, National Road, Blata l-Bajda, Hamrun, Malta HMR 9010
Tel: +356 23952000 – Fax: +356 21242406
e-mail: info@mccaa.org.mt
Website: www.mccaa.org.mt
Netherlands
The Health Care Inspectorate
Stadsplateau 1 3521 AZ Utrecht
Postbus 2680 3500 GR Utrecht
Tel: +31 88 120 50 000
e-mail: meldpunt@igz.nl
Website: www.igz.nl
Norway
The Norwegian Medicines Agency
PO Box 240 Skøyen, 0213 Oslo, Norway
Tel: +47 22 89 77 00
e-mail: meddev-no@noma.no
Website: www.legemiddelverket.no
Poland
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – – Department of Medical
Devices Surveillance, Vigilance and Clinical Trials
Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
Tel: +48 22 492 15 54 – Fax:+48 22 492 11 09
e-mail: incydenty@urpl.gov.pl
Website: http://www.urpl.gov.pl/
Portugal
INFARMED–National Authority of Medicines and Health Products, IP
Parque de Saúde de Lisboa, Avenida do Brasil 53, 1749-004 Lisboa
Tel: +351 217 987 100 – Fax: +351 217 987 316
e-mail: infarmed@infarmed.pt
Website: www.infarmed.pt
Romania
National Agency for Medicines and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
Tel: +4 021 2228652, +4 031 432 9120
Fax: +4 021 2228683, +4 031 432 9121
e-mail: mdevice@anm.ro
Website: www.anm.ro
Slovak Republic
National Institute for Drug Control
Kvetná 11 825 08 Bratislava 26 Slovak Republic
Tel: +421-2-5070 11 11, Fax: +421-2-55 56 41 27
e-mail: sukl@sukl.sk
Website: www.sukl.sk
Slovenia
Agency for Medicinal Products and Medicinal Services
Ptujska ulica 21, 1000 Ljubljana, Slovenia
Tel: +386 (0)8 2000 500 – Fax: +386 (0)8 2000 630
e-mail: info@jazmp.si; meddev@jazmp.si
Website: www.jazmp.si
Spain
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES – 28022 Madrid
e-mail: sgps@aemps.es
Website: http://www.aemps.gob.es/
Sweden
The Medical Products Agency
P.O. Box 26, SE-751 03 Uppsala
Tel: +46 18 17 46 00 – Fax: +46 18 50 31 15
e-mail: meddev.central@mpa.se
Website: www.lakemedelsverket.se
The Health and Social Care Inspectorate
P.O Box 45184, SE-104 30 Stockholm
Tel: +46 10-788 50 00
e-mail: registrator@ivo.se
Website: www.ivo.se
Switzerland
Swissmedic, Swiss Agency for Therapeutic Products
Hallerstrasse 7, CH -3012 Berne,
e-mail: medical.devices@swissmedic.ch
Website: https://www.swissmedic.ch
Turkey
Ministry of Health – Turkish Medicines and Medical Devices Agency
Vice Presidency of Inspectorate – Medical Devices Inspection Department
Söğütözü Mahallesi 2176. Sokak No:5 PK 06520 Çankaya/ANKARA
Tel: +90 312 218 35 34 – Fax: +90 312 218 37 10
e-mail: tibbicihazpgd@titck.gov.tr
Website: http://www.titck.gov.tr
United Kingdom
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road
London SW1W 9SZ
Tel: +44 203 080 6000 – Fax: +44 203 118 9803
e-mail: info@mhra.gsi.gov.uk