Regulatory Standards

Global regulatory authorities setting the standards for medical device safety, quality, and compliance

1
U.S. Food and Drug Administration
FDA
United States
2
European Union Competent Authorities
EU MDR / IVDR system
European Union
3
Medicines and Healthcare products Regulatory Agency
MHRA
United Kingdom
4
Therapeutic Goods Administration
TGA
Australia
5
Health Canada
Health Canada
Canada
6
Pharmaceuticals and Medical Devices Agency
PMDA
Japan
7
National Medical Products Administration
NMPA
China
8
Health Sciences Authority
HSA
Singapore
9
Ministry of Food and Drug Safety
MFDS
South Korea
10
National Health Surveillance Agency
ANVISA
Brazil
11
Swiss Agency for Therapeutic Products
Swissmedic
Switzerland
12
Saudi Food and Drug Authority
SFDA
Saudi Arabia
13
Central Drugs Standard Control Organization
CDSCO
India
14
South African Health Products Regulatory Authority
SAHPRA
South Africa
15
Taiwan Food and Drug Administration
TFDA
Taiwan
16
Turkish Medicines and Medical Devices Agency
TITCK
Turkey
17
Federal Commission for the Protection against Sanitary Risk
COFEPRIS
Mexico
18
National Agency for Food and Drug Administration and Control
NAFDAC
Nigeria
19
New Zealand Medicines and Medical Devices Safety Authority
Medsafe
New Zealand
20
Spanish Agency of Medicines and Medical Devices
AEMPS
Spain