Autoridades competentes y registro de productos sanitarios

País

Bandera

Nombre y Dirección

Belgium

MDR - IVDR

FAMHP - Federal Agency for Medicines and Health Products

Avenue Galilée - Galileelaan 5/03, 1210 Brussels, fax:+32 2 528 4120

E-mail: welcome@fagg-afmps.be

http://www.afmps.be/

Bulgaria

MDR - IVDR

Bulgarian Drug Agency

8 Damyan Gruev Str., BG - 1303 Sofia

E-mail: bda@bda.bg

http://www.bda.bg/

Czech Republic

MDR - IVDR

State Institute for Drug Control, Medical Devices Branch

Šrobárova 48, CZ – 100 41 Prague 10

E-mail: medicaldevices@sukl.cz

http://www.niszp.cz/

Croatia

MDR - IVDR

Agency for Medicinal Products and Medical Devices

Ksaverska cesta 4, 10 000 Zagreb

E-mail: halmed@halmed.hr

Denmark

MDR - IVDR

Danish Medicines Agency

Pharmacovigilance and Medical Devices

Axel Heides Gade 1, DK - 2300 - Kobenhavn

E-mail: med-udstyr@dkma.dk

http://laegemiddelstyrelsen.dk/da/udstyr/

Germany 

MDR-IVDR Legislation

Federal Ministry of Health

Friedrichstr. 108 - 10117 Berlin, fax:+ 49 228 941-4946 

E-mail: medizinprodukte@bmg.bund.de

http://www.bmg.bund.de/ministerium/english-version.html

Authority responsible for notified bodies

Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)

Heinrich-Böll-Ring 10, 53119 Bonn,

E-mail: zlg@zlg.nrw.de

https://www.zlg.de/

MDR - IVDR

Federal Institute for Drugs and Medical Devices

Kurt Georg Kiesinger Allee 3, D - 53175 Bonn,

E-mail: medizinprodukte@bfarm.de

http://www.bfarm.de/cln_103/DE/Home/home_node.html

IVDR

Paul Ehrlich Institute, Section Pharmacovigilance 2

Paul-Ehrlich-Strasse 51-59, D - 63225 Langen,

E-mail: pharmacovigilance2@pei.de

http://www.pei.de/

Estonia 

MDR - IVDR

Health Board, Medical Devices Department

1a Põllu st., EE - Tartu 50303 

E-mail: MSO@terviseamet.ee

http://www.terviseamet.ee/

Ireland

MDR - IVDR

Health Products Regulatory Authority

Kevin O’Malley House, Medical Devices Department, Earlsfort Centre, Earlsfort Terrace, IE - Dublin D02 XP77

E-mail: devices@hpra.ie

http://www.hpra.ie/

Greece 

MDR - IVDR

National Organization for Medicines

284 Mesogion Ave, GR- 15562 Holargos, Athens

E-mail: medicaldevices@eof.gr

http://www.eof.gr/web/guest/home

Spain 

MDR - IVDR

Agencia Española de Medicamentos y Productos Sanitarios

C/ Campezo 1, Edificio 8, ES - 28022 Madrid

E-mail: sgps@aemps.es

http://www.aemps.gob.es/

France 

MDR - IVDR

Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM

143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex

E-mail: dmcdiv@ansm.sante.fr

http://ansm.sante.fr/

Italy 

MDR - IVDR

Ministry of Health Directorate General of Medical Devices and Pharmaceutical Services

via Giorgio Ribotta 5, IT - 00144 Roma

E-mail: segr.dgfdm@sanita.it

https://www.salute.gov.it/portale/p5_11.jsp

Cyprus 

MDR - IVDR

Cyprus Medical Devices Competent Authority

Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia

E-mail: cymda@mphs.moh.gov.cy

https://www.moh.gov.cy/moh/mphs/mphs.nsf/All/A82FE3D75F4BF2CAC225850A0036075A?OpenDocument

Latvia 

MDR - IVDR

Medical Device Evaluation Department State Agency of Medicines

15 Jersikas street, LV - 1003 Riga

E-mail: info@zva.gov.lv

https://www.zva.gov.lv/en

Lithuania 

MDR - IVDR

The State Health Care Accreditation Agency under the Ministry of Health of the Republic of LithuaniaJeruzales str. 21, LT-08420 Vilnius

E-mail: vaspvt@vaspvt.gov.lt

http://www.vaspvt.gov.lt/

Luxembourg 

MDR - IVDR

Ministry of Health 1, rue Charles Darwin L-1433 Luxembourg

E-mail : meddevices@ms.etat.lu

https://sante.public.lu/fr.html

Malta

MDR - IVDR

Malta Medicines Authority - Medical Devices Unit

Sir Temi Żammit Buildings, Malta Life Sciences Park San Ġwann SĠN 3000, Malta

E-mail : devices.medicinesauthority@gov.mt

http://www.medicinesauthority.gov.mt/medicaldevices

Hungary

National Institute of Pharmacy and Nutrition

1051, Budapest, Zrínyi street 3, Hungary

E-mail: amd.vig@ogyei.gov.hu

https://www.ogyei.gov.hu/main_page/

Netherlands

Notification & Registration

Ministry of Health, Welfare and Sports

CIBG Farmatec

Postal address: PO box 16114, NL - 2500 BC The Hague, Visitors address: Rijnstraat 50, NL – 2515 XP Den Haag

E-mail: medische_hulpmiddelen@minvws.nl

https://www.farmatec.nl/medische-hulpmiddelen

Market Surveillance & Vigilance

Dutch Health and Youth Care Inspectorate (IGJ)

Visitor’s address: Stadsplateau 1, 3521 AZ Utrecht,

Postal address: Postbus 2518, 6401 DA Heerlen

E-mail: meldpunt@igj.nl

http://www.igj.nl/

Notification of clinical investigations (MDR) and performance studies (IVDR)

Central Committee on Research Involving Human Subjects (CCMO)

Postal address: P.O. Box 16302, 2500 BH Den Haag

E-mail: devices@ccmo.nl

http://www.ccmo.nl/

Austria

MDR-IVDR

Austrian Federal Office for Safety in Health Care (BASG)

Traisengasse 5, 1200 Wien

E-mail: medizinprodukte@basg.gv.at

https://www.basg.gv.at/

Poland 

MDR-IVDR

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

E-mail: incydenty@urpl.gov.pl

http://www.urpl.gov.pl/

Portugal 

MDR-IVDR

Infarmed - National Authority of Medicines and Health Products

Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa

E-mail: daps@infarmed.pt

http://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos

Romania 

MDR-IVDR

National Agency for Medicines and Medical Devices of Romania

58, Sos. Nicolae Titulescu, sector 1, Bucharest

E-mail: mdevice@anm.ro

http://www.anm.ro/

Slovenia

MDR-IVDR

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia JAZMP

Slovenčeva ulica 22, 1000 Ljubljana

E-mail: meddev@jazmp.si

https://www.jazmp.si/

Slovakia

MDR-IVDR

State Institute for Drug Control, Medical Devices Section

Kvetna 11, SK - 825 08 Bratislava

E-mail: sukl@sukl.sk

http://www.sukl.sk/en

Finland

MDR-IVDR

Finnish Medicines Agency Fimea Medical Devices Unit

Mannerheimintie 166, P.O. Box 55, FI-00034 FIMEA

Email: medicaldevice@fimea.fi, registry@fimea.fi

http://www.fimea.fi/

Sweden

MDR-IVDR

Swedish Medical Products Agency´ 'Läkemedelsverket'

Department of Medical Devices Box 26, SE-751 03 Uppsala

E-mail: registrator@lakemedelsverket.se

http://www.lakemedelsverket.se/

Norway

MDR-IVDR

Statens legemiddelverk/ Norwegian Medicines Agency

Postboks 6167 Etterstad, N-0602 Oslo

E-mail: Meddev-no@noma.no

http://www.noma.no/

Iceland

MDR-IVDR

Icelandic Medicines Agency

Vínlandsleið 14, IS-113 Reykjavík

E-mail: ima@ima.is

http://www.lyfjastofnun.is/

Liechtenstein 

MDR-IVDR

Office of Public Health

Äulestrasse 51, Postfach 684, FL - 9490 Vaduz

E-mail: medical.devices@llv.li

http://www.ag.llv.li/

Turkey

MDR-IVDR

Turkish Medicines and Medical Devices Agency (TITCK) Ministry of Health

Turkish Medicines and Medical Devices Agency Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara

E-mail: md.ivd@titck.gov.tr

http://www.titck.gov.tr/