Medical Device Regulatory Glossary

Find practical definitions of medical device regulatory authorities, laws, databases, and compliance terms, with links to official sources and related market guidance.

A

AMAR (Israel Medical Device Division)

ANATEL (National Telecommunications Agency)

ANMAT (Argentina)

ANVISA (Brazilian Health Regulatory Agency)

ARTG (Australian Register of Therapeutic Goods)

ASEAN Common Submission Dossier Template (CSDT)

ASEAN Medical Device Directive (AMDD)

C

Central Drugs Standard Control Organisation (CDSCO)

Certificate of Free Sale

COFEPRIS (Federal Commission for Protection against Sanitary Risks)

Conformity Assessment

Costa Rica Ministry of Health

D

Decree 3770/2004

Decree 4725/2005

Directorate General of Drug Administration (DGDA)

Drug Regulatory Authority of Pakistan (DRAP)

E

Egyptian Drug Authority (EDA)

Emirates Drug Establishment (EDE)

EU Declaration of Conformity

EUDAMED (European Database on Medical Devices)

European Commission

F

Field Safety Corrective Action (FSCA)

G

General Health Law (Ley General de Salud)

General Safety and Performance Requirements (GSPR)

Global Medical Device Nomenclature (GMDN)

H

Health Canada (HC)

HSA (Health Sciences Authority)

I

IMDA (Infrastructure and Medical Device Administration)

Indonesian Ministry of Health (MoH)

INMETRO (National Institute of Metrology, Quality and Technology)

International Medical Device Regulators Forum (IMDRF)

INVIMA (National Institute for Drug and Food Surveillance)

M

MDA (Medical Device Authority)

MDD (Medical Device Division)

Medical Device Classification

Medical Device Coordination Group (MDCG)

Medical Device Single Audit Program (MDSAP)

Medical Device Technical File

Medsafe (New Zealand)

MHLW (Ministry of Health, Labour and Welfare)

MHRA (Medicines and Healthcare products Regulatory Agency)

Ministry of Food and Drug Safety (MFDS), South Korea

N

National Medical Products Administration (NMPA)

P

Periodic Safety Update Report (PSUR)

Pharmaceutical Administration Bureau (ISAF), Macao

Philippine FDA and CDRRHR

PMDA (Pharmaceuticals and Medical Devices Agency)

Q

Quality Management System Regulation (QMSR)

R

S

Saudi Food and Drug Authority (SFDA)

Swissdamed (Swiss Database on Medical Devices)

Swissmedic (Swiss Agency for Therapeutic Products)

T

Taiwan Food and Drug Administration (TFDA)

TGA (Therapeutic Goods Administration)

Thai FDA (Thailand Food and Drug Administration)

Therapeutic Goods Act 1989 (Australia)

U

Unique Device Identification (UDI)

US FDA (US Food and Drug Administration)

V

Vietnam Ministry of Health (MoH)

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