AustraliaβNew Zealand: TGA and Medsafe joint Trans-Tasman framework β monitor TPA commencementaustraliaπ key dates
Mandatory use of Regulatory Enrolment Process (REP) for medical device applicationscanadaπ key dates
End of EU IVDR transition period β Class B IVDs and Class A sterile IVDseuropean-unionπ key dates
End of EU IVDR transition period β Class B, C, D laboratory IVDs (higher scrutiny categories)european-unionπ key dates
End of EU MDR Article 120 transition period β Class IIb implantable legacy deviceseuropean-unionπ key dates
End of EU MDR Article 120 transition period β Class III, IIa, and IIb non-implantable legacy deviceseuropean-unionπ key dates
Phased expansion of notified medical device categories requiring CDSCO registrationindiaπ key dates
Single Licence Policy β MDA implementation deadline for establishment licencesmalaysiaπ key dates
UDI-K Compliance Deadlines by Device Grade β Unique Device Identification (Korea)south-koreaπ key dates
End of MedDO transitional provisions β CE-marked devices must be notified or registered in swissdamedswitzerlandπ key dates
CE marking transitional arrangement ends β devices on Great Britain market must hold UKCA or approved body certificateunited-kingdomπ key dates
Deadline for medical device sponsors to complete transition from EU MDD to EU MDR for ARTG inclusionaustraliaπ key dates
Deadline for EU MDD to EU MDR transition notification and obligations assessmentaustraliaπ key dates