Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canadacanada📋 regulatory changes
Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devicescanada📋 regulatory changes
Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages)canada📋 regulatory changes
Predetermined change control plans for machine learning-enabled medical devices: Guiding principlescanada📋 regulatory changes
Transparency for machine learning-enabled medical devices: Guiding principlescanada📋 regulatory changes
Updates to the medical device establishment licence application (FRM-0292) and instructionscanada📋 regulatory changes
Delegated Regulation 2025/1920 - UDI Assignment for Spectacle Frames and Lenseseuropean-union📋 regulatory changes
Implementing Regulation (EU) 2025/1234 - Electronic Instructions for Use for Medical Deviceseuropean-union📋 regulatory changes
Implementing Regulation (EU) 2026/977 - Uniform Requirements for Conformity Assessment and Notified Bodieseuropean-union📋 regulatory changes
Regulation (EU) 2017/746 - In Vitro Diagnostic Medical Devices Regulation (IVDR)european-union📋 regulatory changes
Regulation (EU) 2023/607 - Extended Transition Periods for Medical Deviceseuropean-union📋 regulatory changes
Regulation (EU) 2024/1860 - Extension of Transition Periods and Eudamed Roll-outeuropean-union📋 regulatory changes
Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devicesjapan📋 regulatory changes
Ministerial Ordinance on Standards for Quality Assurance for Medical Devices (GQP)japan📋 regulatory changes