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Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. Devices manufactured and used in healthcare institutions General information and notes on in-house devices according to MedDO and IvDO New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices…
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January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK HSA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment: joint annual report Page summary: Joint annual report includes brief toxicological background to the Committees’ decisions; discussion summaries; Committees’ published statements. Change made: Added 2022 joint annual report.
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January 3, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

FDA publishes a new draft guidance on 510(k) Third Party Review Program

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by…
admin
January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added recording of ‘MHRA International Recognition Webinar November 2023’. *Please note this update does not include medical and IVD devices. Notify the MHRA about a clinical investigation for a medical device Page summary:…
admin
January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New MHRA monthly newsletter

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Subscribe to their new monthly newsletter to stay informed on what is going on at the MHRA. MHRA Newsletter December 2023 Please note this is an extract of the original bulletin. Clinical Trials and Investigations Performance The latest MHRA performance data shows…
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January 3, 2024
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