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Regulatory Affairs Newsletter

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. Digital identity certification for right to work, right to rent and criminal record checks Page summary: Guidance on how digital identity providers can become certified to complete digital identity checks for the ‘Right to Work’, ‘Right to Rent’ and DBS schemes. Change made: Links to some certification documents have been…
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January 9, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. The Classification, Labelling and Packaging of Substances and Mixtures (Amendment and Consequential Provision) Regulations 2023 Page summary: This Statutory Instrument makes the necessary legislative amendments to update the statute book by removing references to the revoked Annex VIII of GB Classification, Labelling and Packaging of Substances and Mixtures Regulation. Change…
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January 3, 2024
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…
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January 3, 2024
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