Australia–New Zealand: TGA and Medsafe joint Trans-Tasman framework — monitor TPA commencement

australia📅 key dates

Medical Device and Cosmetics Act 2023 — Bangladesh's New Regulatory Framework

bangladesh📋 regulatory changes

RDC 751/2022 — ANVISA's Updated Medical Device Registration Regulation

brazil📋 regulatory changes

UDI Implementation — Brazil ANVISA Unique Device Identification Requirements

brazil🔄 reform tracker

Mandatory use of Regulatory Enrolment Process (REP) for medical device applications

canada📅 key dates

Medical Device Supervision and Administration Regulations — Order No. 739 (2021)

china📋 regulatory changes

UDI Mandatory Implementation — Class III (Completed) and Class II (In Progress)

china🔄 reform tracker

End of EU IVDR transition period — Class B IVDs and Class A sterile IVDs

european-union📅 key dates

End of EU IVDR transition period — Class B, C, D laboratory IVDs (higher scrutiny categories)

european-union📅 key dates

End of EU MDR Article 120 transition period — Class IIb implantable legacy devices

european-union📅 key dates

End of EU MDR Article 120 transition period — Class III, IIa, and IIb non-implantable legacy devices

european-union📅 key dates

MDACS — Medical Device Administrative Control System (Voluntary Scheme)

hong-kong📋 regulatory changes

Proposed Mandatory Medical Device Registration — Legislative Reform

hong-kong🔄 reform tracker

Medical Devices Rules 2017 — India's Risk-Based Regulatory Framework

india📋 regulatory changes

Phased expansion of notified medical device categories requiring CDSCO registration

india📅 key dates

UDI India Framework and UDID National Database

india🔄 reform tracker

BPOM Medical Device Regulations — Indonesian Regulatory Framework

indonesia📋 regulatory changes

Foreign Manufacturer Accreditation (FMA) — 5-Year Renewal Cycle

japan📅 key dates

Single Licence Policy — MDA implementation deadline for establishment licences

malaysia📅 key dates

Abbreviated Registration Pathway for Devices Approved by Reference Authorities

mexico🔄 reform tracker