Industry Newsletters Regulatory Affairs Newsletter Archive – Page 8

Industry Newsletters Regulatory Affairs Newsletter Industry Newsletters Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

Health Canada and the Public Health Agency of Canada’s report on red tape reduction

Health Canada and the Public Health Agency of Canada have conducted a broad review of regulations and program administration to identify outdated, inefficient or duplicate regulations that hinder economic growth and create unnecessary burden for businesses and people in Canada. View article...

Ben KempSeptember 12, 2025

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CLC/TC 106X – Electromagnetic fields in the human environment

The new technical report CLC/TR 50734:2025 - Application of EMF standards to combined products - can be found here.

Ben KempSeptember 12, 2025

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Be Ready When It Matters Most: New POCT Emergency Guidance Available

CLSI have published Guidance POCT16 | Emergency and Disaster Point-of-Care Testing. It is US focused, but may be useful.

Ben KempSeptember 12, 2025

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EN IEC 63366:2025

Standard for conducting LCAs for Electrical and Electronic Equipment. Not sure if there is work ongoing separately for a MD or IVD LCA. EN IEC 63366:2025 - Product category rules for life cycle assessment of electrical and electronic products and systems (publication date=2025-08-01) View article...

Ben KempSeptember 8, 2025

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SAHPRA – Regulatory Requirements of AI and ML Enabled Medical Devices

You can find the latest information here.

Ben KempSeptember 8, 2025

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IMDRF Implementation Report 2025 Ed 2

Please find here second edition of the IMDRF 2025 Implementation report. This provides an overview of the degree to which IMDRF Guidance etc. has been applied to the regulatory frameworks of the IMDRF member countries.

Ben KempSeptember 8, 2025

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SAHPRA – Reprocessing of Single Use Medical Devices

You can find the latest information here: https://www.sahpra.org.za/wp-content/uploads/2025/08/COMM-Issue-No.-MD07_2025_26-v2-2.pdf

Ben KempSeptember 8, 2025

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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 KempSeptember 8, 2025

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TGA – Understanding regulation of software-based medical devices

You can find the Australian Government's release here: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices

Ben KempSeptember 8, 2025

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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 KempSeptember 8, 2025