USA in the Global Regulatory Landscape

FDA's international role

• IMDRF founding member — the US was a founding participant of the International Medical Device Regulators Forum
• Global benchmark — FDA 510(k) clearance and PMA approval are used as reference points in recognized and of multiple countries including Australia, Singapore, and Canada, demonstrating FDA's influence in international regulatory harmonization reliance pathways
• GMP mutual recognition — FDA has MRAs for GMP inspections with EU, Canada, and others

Quick comparison

Jurisdiction	Body	Submission	Equivalent to
USA	FDA / CDRH	510(k) / PMA / De Novo	—
Australia	TGA	ARTG inclusion	510(k) / PMA
EU	Notified body	CE marking (MDR)	510(k) / PMA
Canada	Health Canada	Device Licence	510(k) / PMA
Singapore	HSA	Product registration	510(k) / PMA

Official resources

• IMDRF
• FDA — International Programs