Click here to open a printer-friendly view of the page

Click here to return to the TOPRA home page

Medical technology links



Here are links to useful companies and resources in the Medical technologies industry.




USEFUL WEBSITES FOR  MEDICAL TECHNOLOGY REGULATORY AFFAIRS

Abbreviation

Title

Web Address

ABHI

Association of British Healthcare Industries

www.abhi.org.uk

BSI

British Standards On-Line

http://www.bsi.org.uk/bsi/products/standards/moreinfo/index.xhtml

 

BVMed

BVMed Bundesfachverband Medizinprodukteindustrie e.V.

http://www.bvmed.de/

 

CEN / CENLAC

European Committee for Standardization

http://www.cenorm.be/

 

DIMDI

Deutsches Institut für Medizinische Dokumentation und Information

http://www.dimdi.de/

 

EC

The European Commission

http://www.europa.eu.int/

 

EC (DGIII)

The European Commission / DG III / Medical Devices

http://europa.eu.int/comm/dg03/directs/dg3d/d2/meddev/meddev.htm

EC (DG III- EUDRALEX)

The Pharmaceuticals and Cosmetics Unit of the EC’s Directorate General for Industry. EUDRALEX (Access to copies of directives, guideline, Notice to Applicants, etc.)

http://dg3.eudra.org/eudralex/index.htm

 

EDMA

European Diagnostic Manufacture Association

 

EMEA

The European Agency for the Evaluation of Medicinal Products

http://www.eudra.org/en­_home.htm

EUCOMED

European Association of Medical Device Supplies

http://www.eucomed.be/eucomed/index.htm

FDA

Food and Drug Administration (FDA)

http://www.fda.gov

FDA

Food and Drug Administration (FDA) – Guidance Documents

http://www.fda.gov/cder/guidance/index.htm

 

GHTF

Global Harmonisation Task Force

www.ghtf.org

GMDN

Global Medical Devices Nomenclature

www.Gmdn.org

ICH

International Conference on Harmonisation of Technical Requirements

http://www.ifpma.org/ich1.html

 

ISO

International Standards Organization

www.iso.ch

 

MDA

The Medical Devices Agency (UK Competent Authority)

http://www.medical-devices.gov.uk

OJ

Official Journal of the European Communities (OJ)

http://europa.eu.int/eur-lex/en/oj/index.html

RAInfo

Regulatory Affairs Information Home Page

http://www.medmarket.com/tenants/rainfo/rainfo.htm

RAPS

Regulatory Affairs Professionals Society

http://www.raps.org

WHO

World Health Organisation

http://www.who.int/

 

USEFUL WEB SITES FOR REST OF WORLD

Country

Name

Web Address

Argentina

Argentina National Administration of Drugs, Food & medical Technology. (Spanish / English)

http://www.anmat.gov.ar

 

Australia

Therapeutic Goods Administration (TGA)

http://www.health.gov.au/tga/

Brazil

Ministry of Health (Portuguese)

http://www.datasus.gov.br

Canada

Health Protection Branch (HPB)

http://www.hc-sc.gc.ca/hpb/

Czech Republic

State Institute for Drug Control (Czech/English)

http://www.sukl.cz

Columbia

Ministry of Health

http://www.minsalud.gov.co

Estonia

Estonian Stage Agency of Medicines

http://www.sam.ee

Estonia

State Agency of Medicines

http://www.sam.ee/enginedex.html

Germany

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

http://www.bfarm.de/de_ver/

Germany

Bundesministeriums für Gesundheit

http://www.BMGesundheit.de/

Hungary

National Institute of Pharmacy (Magyar / English / Russian)

http://www.ogyi.hu/

Iceland

Ministry of Health and Social Security (Icelandic / English)

http://brunnur.stijr.is/interpro/htr/htr.nsf/pages/front

Japan

Ministry of Health and Welfare (MHW)

http://www.ncc.go.jp/mhw/index.html

Latvia

State Agency of Medicines (Latviski / English)

http://www.vza.gov.lv/

Lithuania

State Medicines Control Agency

http://www.vvkt.lt/defaeng.html  & http://www.vvkt.lt

Luxembourg

Ministry of Health (French)

http://www.santel.lu/MIN/home.html

Malta

Ministry of Health (English)

http://www.magnet.mt/ministries/health/

New Zealand

Medsafe (English)

http://www.medsafe.govt.nz

Nordic Countries

Nordic Council on Medicines (NLN)

http://www.nln.se/

Norway

Ministry of Health (English / Norwegian)

http://odin.dep.no/shd/eng/index.html

Poland

Poland

Drug Institute

Ministry of Health and Social Security (Polish)

http://www.il.waw.pl

http://www.mzios.gov.pl/

Russia

Public Health Institute (English & Russian)

http://views.vcu.edu/view

Slovak Republic

State Institute for Drug Control (Statny ustav pre controlu lieciv – SUKL)

Ministry of Health (Slovak / English – under construction)

http://www.sukl.sk/

http://www.health.gov.sk/

Slovenia

Agency for Medicinal Products (English)

http://www.gov.si/mz/amp.htm

Switzerland

Interkantonale Kontrollstelle fur Heilmittel (IKS)

http://www.pharmapart.com/swisspharmanet/behoerde/iks/iks0001.htm

Turkey

Ministry of Health (English)

http://www.health.gov.tr/

United States

Center for Drug Evaluation and Research (CDER)

http://www.fda.gov/cder/

 

Center for Biologicals Evaluation and Research (CBER)

http://www.fea.gov/cber/

 

Food and Drug Administration (FDA)

http://www.fda.gov

 

FDA modernisation

http://www.fda.gov/cder/fdama/default.htm

 

EEC-EMEA

The European Agency for the Evaluation of Medicinal Products

http://www.eudra.org/en_home.htm

EEC-MRFG

European Heads of Agencies site

http:// heads.medagencies.org

Austria

Federal Ministry of Labour, Health and Social Affairs

http://www.bmags.gv.at/

Belgium

Ministry of Public Health

no site at present – see Heads of Agencies site

Belgium

Ministry of Social Affairs, Public Health and Environment. (French / Flemish / English)

http://www.health.fgov.be/

Denmark

Danish Medicines Agency

http://www.dkma.dk/

Finland

National Agency for Medicines (Laakelaitos)

http://www.nam.fi/

France

Agence du Médicament

http://agmed.sante.gouv.fr/

Germany

BGVV

http://www.bgvv.de/

 

FfArM

http://www.bfarm.de/

 

Paul Ehrlich Institute

http://www.pei.de/

Greece

National Drug Organisation

no site at present – see Heads of Agencies site

Ireland

Irish Medicines Board

http://www.imb.ie

Italy

Ministero dell Sanita

http://www.sanita.it/farmaci/

Luxembourg

Division de la Pharmacie et des Médicaments

no site at present – see Heads of Agencies site

Netherlands

Medicines Evaluation Board

http://www.cbg-meb.nl/

Portugal

Infarmed

http://www.infarmed.pt

Spain

Direcction General de Farmacia y Productos Sanitorios/Ministerio de Sanidad y Consumo

http://www.msc.es/

Sweden

Medical Products Agency (MPA)

http://www.mpa.se

UK                                         

 

 

 

MDA – Medical Devices Agency

http://www.medical-devices.gov.uk/

 

- list of bulletins and guidance:

http://www.medical-devices.gov.uk/reg-guid.htm

 

Committee on the Safety of Medicines (CSM)

http://www.open.gov.uk/mca/csmhome.htm

 

National Institute for Biological Standards Control (NIBSC)

http://www.nibsc.ac.uk/

 

 

 

http://www.swissmedic.ch/

 


 
 Home  Help  Contact us  Site map  Members logon