Essentials of European Medical Device Regulatory Affairs - June 2020

Regulatory Bodies Worldwide

Argentina

ANMAT Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica INAME Instituto Nacional de Medicamentos (National Institute of Drugs)

www.anmat.gov.ar/

http://www.anmat.gov.ar/weba nmat/institucional/organizada.a sp

Australia

TGA - Therapeutic Goods Administration

www.tga.gov.au

www.apvma.gov.au

Australian Pesticides and Veterinary Medicines Authority

Brazil

ANVISA - Agencia Nacional de Vigilancia Sanitaria

http://portal.anvisa.gov.br/wps/ portal/anvisa-ingles

Canada

Health Canada

www.hc-sc.gc.ca

Health Canada - Health Products and Food Branch, Inspectorate

www.hc-sc.gc.ca/ahc- asc/branch-dirgen/hpfb- dgpsa/hpfi-ipsa/index-eng.php

China

http://eng.sfda.gov.cn/WS03/C L0755/

SFDA - State Food and Drug

Administration

Japan

Ministry of Health, Labour and Welfare

www.mhlw.go.jp

www.info.pmda.go.jp

Pharmaceuticals and Medical Devices Agency (PMDA)

Israel

Ministry of Health

http://www.health.gov.il/english /

Malaysia

NPCB National Pharmaceutical Control Bureau

http://portal.bpfk.gov.my/

New Zealand

Ministry of Health

http://www.health.govt.nz/

MEDSAFE - Medicines and Medical Devices Safety Authority

www.medsafe.govt.nz/

Ministry of Agriculture and Forestry

www.maf.govt.nz

http://www.foodsafety.govt.nz/i ndex.htm

New Zealand Food Safety Authority

Singapore

HSA - Health Sciences Authority

http://www.hsa.gov.sg/publish/

6

September 2013