§ COMPARE REGULATORS

FDA vs TGA: US and Australia Medical Device Regulation Compared

Compare FDA and TGA medical device pathways — ARTG registration, MDSAP recognition, classification differences, and post-market requirements.

FDA

U.S. Food and Drug Administration

United States

The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enfo…

CLASSES

Class I, II, III

PATHWAY

510(k), PMA, De Novo, HDE

KEY FUNCTIONS
  • ▸510(k) clearance and PMA approval
  • ▸MAUDE adverse event database
  • ▸FDA Enforcement Reports and recalls
  • ▸De Novo classification
  • ▸Breakthrough Device Designation

TGA

Therapeutic Goods Administration (Australia)

Australia

The TGA regulates medical devices in Australia under the Therapeutic Goods Act 1989. Australia uses a risk-based classification system aligned with GHTF/IMDRF. The TGA is an MDSAP participating author…

CLASSES

Class I, IIa, IIb, III, AIMD

PATHWAY

ARTG inclusion via conformity assessment

KEY FUNCTIONS
  • ▸ARTG registration
  • ▸Conformity assessment
  • ▸MDSAP participation
  • ▸Adverse event reporting
  • ▸Post-market surveillance

MedFlux monitors both FDA and TGA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.

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§ OTHER COMPARISONS

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FDA vs NMPA

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FDA vs PMDA

Compare FDA 510(k)/PMA with PMDA Shonin/Ninsho — classification, QMS (Ordinance 169 vs 21 CFR 820), …

EMA vs NMPA

Compare EU MDR CE marking with NMPA registration — Notified Bodies vs CMDE, UDI requirements, clinic…