NBOG National Contact Points
In order to encourage better communication Member States established a communication protocol (see ANNEX 1 to Section 2 of the Designating Authorities
Handbook) and national contact points.
The aims of the communication protocol are to encourage examples of possible poor performance to be passed to the appropriate Member State/Designating Authority for
investigation.
In addition, the named individuals listed below can be used as a contact point by anyone wishing to obtain information on designation and control of Notified Bodies in individual countries.
| Austria |
Bundesministerium für Gesundheit, Familie und Jugend Abteilung III/A/2 Radetzkystraße 2 A-1031 Wien Mr Dr. Martin Renhardt e-mail martin.renhardt@bmgfj.gv.at Fax +43-1-711004-1590 Phone +43-1-711004-487 URL http://www.bmgfj.gv.at |
| Belgium |
Federal Agency for Medicines and Health Products AFMPS/FAGG Health Products Division Eurostation II Place Victor Horta 40 b40 B-1060 Brussels Ms Frédérique Meulders e-mail meddev@fagg.be Fax +32-2-524-8120 Phone +32-2-524-8322 URL http://www.fagg.be |
| Bulgaria |
State Agency for Metrological and Technical Surveillance "Designation of Conformity Assessment Bodies" Directorate 21."6-th Septemvri",Str. BG-1000 Sofia Ms Mariana Tsaneva e-mail comfass@mail.orbitel.bg Fax +359-2-986-17-07 Phone +359-2-981-00-89 |
| Cyprus |
Cyprus medical Devices Competent Authority Prodromou 1 & Chilonos 17 Corner CY-1449 Nicosia Ms Maria Athanasiadou e-mail cymda@mphs.moh.gov.cy Fax +35-722375120 Phone +35-722867185 |
| Czech Republic |
Czech Office for Standards, Metrology and Testing Biskupský dvůr 1148/5 CZ-11000 Prague 1 Mr. Michal Vindyš e-mail vindys@unmz.cz Phone +420-221-802-180 URL http://www.unmz.cz |
| Denmark |
Danish Medicines Agency Axel Heides Gade 1 DK-2300 Copenhagen S Ms Neel Larsen e-mail med-udstyr@dkma.dk Phone +45-44889542 URL http://laegemiddelstyrelsen.dk |
| Estonia |
Health Board Põllu 1a EE-50303 Tartu Ms Kristina Kübar e-mail mso@terviseamet.ee Phone +372 5330 5236 URL http://www.terviseamet.ee/en/medical-devices |
| Finland |
National Supervisory Authority for Welfare and Health Lintulahdenkuja 4 SF-00530 Helsinki Mr Heikki Mattlar e-mail heikki.mattlar@valvira.fi Fax +358-295-209-702 Phone +385-295-209-506 URL http://www.valvira.fi |
| France |
Agence Nationale de sécurité du médicament et des produits de santé (National Drug and Health Products Safety Agency) 143-147 Bd Anatole France F-93285 Saint-Denis cedex Mrs Sophie Roques e-mail Sophie.ROQUES@ansm.sante.fr Fax +33-1-5587-4052 Phone +33-1-5587-3977 URL http://www.ansm.sante.fr |
| Germany |
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Heinrich-Böll-Ring 10 D-53119 Bonn Mr Dr. Rainer Edelhäuser e-mail rainer.edelhaeuser@zlg.nrw.de Fax +49-228-97794-44 Phone +49-228-97794-10 URL https://www.zlg.de |
| Greece |
National Organisation for Medicines (EOF) Manufacturing and Marketing Surveillance Division Inspection SectionInspection Section 284 Mesogeion Avenue GR-15562 Holargos Mr Dr. Haralabos Katsoulas e-mail hkatsoulas@eof.gr Fax +30-2132040500 Phone +30-2132040280 URL http://www.eof.gr |
| Hungary |
National Institute of Medicines and Nutrition (OGYÉI) Department of Medical Devices Mail: Budapest 1372 P.O. Box: 450. Hungary |
| Iceland |
Directorate of Health Austurströnd 5 IS-170 Seltjarnarnes Ms Anna Björg Aradottir e-mail annabara@landlaeknir.is Fax +354-510-1900 Phone +354-510-1900 URL http://www.landlaeknir.is |
| Ireland |
Health Products Regulatory Authority (HPRA) Kevin O´Malley House Earlsfort Centre, Earlsfort Terrrace IRL-Dublin 2 Mr Owen Melia e-mail devices@hpra.ie Fax +353-1-676-7836 Phone +353-1-676-4971 URL http://www.hpra.ie |
| Italy |
Ministry of Health Directorate General of medical devices, pharmaceutical services and safety in healthcare Office III - medical Devices Via G. Ribotta 5Via G. Ribotta 5 I-00144 Roma Mrs Antonella Colliardo e-mail a.colliardo@sanita.it Fax +39-06-5994-2523 Phone +39-06-5994-3968 URL http://www.ministerosalute.it/dispositivi/dispomed.jsp |
| Latvia |
Medical Devices Board for Latvia Health Statistics and Medical Technologies State Agency, MoH Latvia 12/22 Duntes street LV-1005 Riga Mr Alnis Dambergs e-mail alnis.dambergs@vsmtva.gov.lv Fax +371-7-50-15-91 Phone +371-67-50-15-93 URL http://www.vsmtva.gov.lv |
| Liechtenstein |
Amt für Volkswirtschaft Technische Prüf-, Mess- und Normenstelle (TPMN) Postfach 684 Städtle 49 LIE-9490 Vaduz Mr Thomas Näf e-mail tpmn.avw@llv.li Fax +423-236-68-89 Phone +423-236-69-03 URL http://www.avw.llv.li |
| Lithuania |
State Health Care Accrediation Agency Under the Ministry of Health of the Republic of Lithuania Zalgirio st. 92 LT-09303 Vilnius Ms Jolanta Karavackaite e-mail vaspvt@vaspvt.gov.lt Fax +370-5-2127310 Phone +370-5-2615177 URL http://www.vaspvt.gov.lt |
| Luxembourg |
Ministère de la Santé Villa Louvigny - alleé Marconi L-2120 Luxembourg Mr Gerard Scharll e-mail gerard.scharll@ms.etat.lu Fax +352-26-20-32-96 Phone +352-24-78-56-34 URL http://www.etat.lu/MS/DIV_MECU/dispositifs.htm |
| Malta |
Malta Competition and Consumer Affairs Authority Technical Regulations Division Mizzi House National Road Blata l-Bajda, Hamrun HMR9010 Malta Ms Ingrid Borg e-mail ingrid.borg@mccaa.org.mt Fax +356-2124-2406 Phone +356-2395-2290 URL http://www.mccaa.org.mt |
| Netherlands |
Dutch Healthcare Inspectorate P.O. Box 2680 3500 BS Utrecht Mr L. W. Meinders e-Mail meldpunt@igz.nl Fax +31-88-12050001 Phone +31-88-120500 URL http://www.igz.nl |
| Norway |
Norwegian Medicines Agency Medical devices team Postboks 6167 Etterstad N-0602 Oslo Mrs Eli Neegaard e-mail meddev-no@legemiddelverket.no Phone +47-901-89-208 URL https://legemiddelverket.no |
| Poland |
Ministry of Health Drug Policy and Pharmacy Department Medical Device Division 15, Miodowa Street PL-00-952 Warsaw Mrs Agnieszka Ostrowska e-mail jednostkinotyfikowane@mz.gov.pl Fax +48-22-8314354 |
|
Portugal
|
INFARMED, I.P. National Authority of Medicines and Health Products Paryue de Saude de Lisboa Av. do Brazil, no 53 P-1749-004 Lisboa Ms Judite Neves e-mail judite.neves@infarmed.pt Fax +351-21-79872-81 Phone +351-21-79872-35 URL http://www.infarmed.pt |
|
Romania
|
National Agency for Medicines and Medical Devices 48 Aviator Sanatescu street, sector 1 R-011478 Bucharest Ms Ioana Tene e-mail ioana.tene@anmdm.ro Fax +40-21-222-8683 Phone +40-21-222-8652 URL https://www.anm.ro |
|
Slovak Republic
|
Slovak Office of Standards, Metrology and Testing Department of Testing Stefanovicova 3, P.O. BOX 76 SK-81005 Bratislava Mrs Monika Laurovičová e-mail monika.laurovicova@normoff.gov.sk Fax +421-2-5249-7887 Phone +421-2-5249-1147 URL http://www.unms.sk |
|
Slovenia
|
Agency for Medial Products and Medial Devices of the Republic of Slovenia Slovenčeva ulica 22 SLO-1000 Ljublijana Mrs Marcia Elena Podboršek e-mail marcia.podborsek@jazmp.si Fax +386-82000-510 Phone +386-82000-500 URL http://www.jazmp.si |
|
Spain
|
Ministerio de sanidad, servicios sociales e igualdad Agencia Española de Medicamentos y Productos Sanitarios Parque Empresarial Las Mercedes Edificio 8.C/ Campezo 1. E-28022 Madrid Ms Carmen Abad e-mail sgps@aemps.es Fax +34-91-82252-89 Phone +34-91-82254-99 URL http://www.aemps.gob.es |
|
Sweden
|
SWEDAC Styrelsen för ackreditering och teknisk kontroll Swedish Board for Accreditation and Conformity Assesment Box 878 SE-50115 Borås Ms Stina Nylén e-mail stina.nylen@swedac.se Phone +46-33-177741 URL http://www.swedac.se |
| Switzerland |
Swissmedic, Schweizerisches Heilmittelinstitut Swiss Agency for Therapeutic Products Marktkontrolle Hallerstraße 7 CH-3000 Bern 9 Mr Dr. Michael Köhli e-mail medical.devices@swissmedic.ch Fax +41-58-462-76-46 Phone + 41-58-463-22-51 URL http://www.swissmedic.ch |
|
Turkey
|
Republic of Turkey Ministry of Health Department of Medical Devices Notified Body and Clinical Trials Section of Notified Body Söğütözü Mahallesi 2176. Sokak No:5 Kat:6 TR-06520 Çankaya / Ankara Mr Fatih Topuz |
|
United Kingdom
|
Medicines & Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf London, E14 4PU, UK Dr Margarida Carlos e-mail Devices.Regulatory@mhra.gov.uk Phone +44208-080-7023 URL http://www.mhra.gov.uk |
|
Australia
|
Therapeutic Goods Administration (TGA) Marketing Authorisation Group PO Box 100P Woden ACT 2606 Australia Ms Andrea Kunca e-mail andrea.kunca@tga.gov.au URL http://tga.gov.au |
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