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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 Kemp
September 8, 2025
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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 1st Sept)

Streamlined regulation to power growth and boost British industry Page summary: Environmental permitting for industry and energy to be modernised, as part of new plans following the landmark Corry Review Change made: First published. Time updated: 9:00am, 26 August 2025 Industrial emissions: modernising environmental permitting Page summary: Seeking views on regulatory reforms to the environmental permitting framework for industrial emissions.…
Ben Kemp
September 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 1st Sept)

UK-India Trade Deal Page summary: Guidance, explainers and other documents to help you understand the Free Trade Agreement between the UK and India. Change made: Copy added to the explainers section of the page as well as ‘Historic India Trade Deal – Huge Boost for Scotland’s Economy’ added to Negotiating the Trade Agreement. Time updated: 1:01pm, 26 August 2025 The…
Ben Kemp
September 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA: Intermediate products – Import Information Notes

Intermediate products – Import Information Notes Page summary: Guidance for vets, importers and border control officials when importing intermediate products to Great Britain. Change made: Updated to clarify that unprocessed raw material is not considered an intermediate product. Also updated guidance on required documentation. From 30 April 2025, EU traders can choose to use importer declarations for these products. From…
Ben Kemp
September 8, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

RCPATH – Self-sampling at the point-of-care – enhancing access, improving care

Self-sampling at the point-of-care – enhancing access, improving care As the UK regulator for medical devices, the MHRA ensures that self-sampling devices are safe, effective, and properly registered before they can be used. This article, which the MHRA have co-authored with the Royal College of Pathologists, sets out clear guidance on regulation, including device marking (UKCA/CE), transport requirements, and the…
Ben Kemp
September 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Reminder: Defra is consulting on extensions to transitional registration deadlines

Defra UK REACH Consultation: extension of transitional registration deadlines The Defra UK REACH Consultation on the extension of transitional registration deadlines is still open. Defra want to hear your views on government proposals to extend: the UK REACH deadlines for businesses to submit dossiers for transitional registrations the dates for HSE (the UK REACH agency) to carry out compliance checks…
Ben Kemp
September 8, 2025
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