Essentials of European Medical Device Regulatory Affairs

hsaportal/en/home.html

South Africa

MCC - Medicines Control Council

http://www.mccza.com/

Switzerlan d

Swissmedic, Schweizerisches Heilmittelinstitut

www.swissmedic.ch

United States

FDA -. Food and Drug Administration

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

CDER- Center for Drug Evaluation and Research

http://www.fda.gov/Drugs/defa ult.htm

CBER- Center for Biologics Evaluation & Research

http://www.fda.gov/BiologicsBl oodVaccines

CDRH- Center for Devices and Radiological Health

http://www.fda.gov/MedicalDev ices/default.htm

7

September 2013