Swissmedic Publishes Swiss Implementation Guide v2.0 for eCTD v4.0
Swissmedic has published version 2.0 of its Swiss Implementation Guide package for eCTD v4.0, including updated implementation guidance, controlled vocabulary and validation criteria ahead of the planned 2027 go-live.
Swissmedic Updates Guidance on Products Without an Intended Medical Purpose
Swissmedic has updated its guidance on products without an intended medical purpose, clarifying transitional provisions, conformity assessment, registration and economic operator obligations under the Swiss MedDO.
Anvisa Publishes Recognized Technical Standards for Medical Devices
Anvisa has published lists of recognized technical standards for medical devices, supporting product development, technical dossiers and demonstration of compliance with safety and performance requirements in Brazil.
UK Moves to Indefinitely Recognise CE-Marked Medical Devices and IVDs in Great Britain
MedTech Europe, ABHI and BIVDA have welcomed the UK Government’s decision to indefinitely recognise CE-marked medical devices and IVDs in Great Britain.
Anvisa Opens Consultation on Possible Expansion of MDSAP in Brazil
Anvisa has opened a targeted consultation to gather industry input on the possible expansion of the Medical Device Single Audit Program (MDSAP) in Brazil. Contributions are open until 9 November 2026.
IMDRF Opens Call for Training Providers for New Endorsement Model Pilot
IMDRF has opened a call for Expressions of Interest from external organisations to participate as training providers in its Training Endorsement Model Pilot, with initial activities planned for Brazil in September 2027.
FDA Expands PCCP Transparency for Future Medical Device Changes
FDA has published expanded information on Predetermined Change Control Plans, including PCCP structure, eligible submission pathways and a public list of authorized devices with PCCPs.
EMA Updates CECP Expert Panel Opinion List for High-Risk Medical Devices
EMA has updated its list of CECP Expert Panel opinions for high-risk medical devices undergoing conformity assessment, including a new Class III circulatory system device opinion issued in October 2026.
European Stakeholders Call for a Single Regulatory Pathway for AI-Enabled Medical Technologies
European healthcare and industry organisations are calling for AI-enabled medical devices and diagnostics to be regulated through a single MDR/IVDR pathway integrating relevant AI Act requirements.
ISO October 2026 Update Highlights Key Medical Device and IVD Standards
The ISO October 2026 update highlights new and developing standards covering sterilization, medical device packaging, implants, catheters, IVDs, NGS workflows, rapid diagnostics and health informatics.
TGA Updates Guidance on Clinical Decision Support Software Regulation
TGA has updated its guidance on Clinical Decision Support System software, clarifying when CDSS is excluded, exempt from ARTG inclusion or subject to full medical device regulation in Australia.
MHRA Updates Medical Device Registration Guidance for Great Britain and Northern Ireland
MHRA has updated its medical device registration guidance, clarifying registration requirements, DORS fees, Northern Ireland obligations, importer information and post-market responsibilities.
WHO Sets 2030 Strategy to Detect Emerging Health Threats Within 24 Hours
WHO’s Pandemic and Epidemic Intelligence Hub has launched its 2026–2030 strategy, aiming to detect and understand new health threats within 24 hours through stronger surveillance, AI, genomics and digital intelligence.
Swissmedic Updates eMessage Functions for Medical Device Regulatory Correspondence
Swissmedic has updated its eMessage functions information sheet, clarifying electronic submissions, responses, acknowledgements, inbox management and digital signatures for medical device regulatory correspondence.
MHRA Updates Real-World Evidence Guidance for Medicines and Medical Devices
MHRA has updated its Real-World Evidence knowledge and guidance resource, covering regulatory standards, RWD quality, clinical studies, post-market use, scientific advice and support for medicines and medical devices.
FDA Issues Guidance on Postapproval Manufacturing Changes for Biosimilars
FDA has issued final guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products, covering reporting categories, comparability, CMC data and new dosage forms or strengths.
FDA Seeks OMB Clearance to Continue MedSun Medical Device Adverse Event Surveillance
FDA has submitted the MedSun adverse event information collection program for OMB review, supporting continued surveillance of medical device deaths, serious injuries and malfunctions through approximately 300 participating facilities.
FDA Expands CDRH Learn With New UDI and Biocompatibility Training Modules
FDA has expanded CDRH Learn with new October 2026 modules covering Unique Device Identification and extraction approaches for chemical analysis in medical device biocompatibility assessment.
FDA Highlights Extraction Approaches for Biocompatibility and Chemical Characterization Testing
FDA’s September 2026 Town Hall focused on extraction approaches for chemical characterization testing under ISO 10993-18 and common issues in medical device biocompatibility assessment.
Health Canada Updates Medical Device Shortage and Discontinuation Reporting Guidance
Health Canada has issued Version 4 of GUI-0137, updating requirements for reporting medical device shortages and discontinuations and providing shortage-related information under the Medical Devices Regulations.