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Regulatory Affairs Newsletter Archive

TGA – HealthCare Facility – Mandatory Adverse Event Reporting introduced Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

TGA – HealthCare Facility – Mandatory Adverse Event Reporting introduced

You can find the latest information here: https://www.tga.gov.au/resources/guidance/reporting-medical-device-adverse-events-healthcare-facilities
Ben Kemp
September 8, 2025
Health Canada: Guidance for determining medical device application type Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Canada: Guidance for determining medical device application type

Health Canada have updated/published their Guidance for determining medical device application type:   This document provides guidance to medical device manufacturers on the different application types listed in the Medical Devices Regulations, including how to determine when medical devices can be combined and submitted as one application. View article...
Ben Kemp
September 8, 2025
MHRA Update: Clinical investigations for medical devices Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update: Clinical investigations for medical devices

Clinical investigations for medical devices Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added new flow chart and guidance documentation for UK and Northern Ireland. Time updated: 11:18am, 27 August 2025
Ben Kemp
September 8, 2025