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CLSI October Newslettter

Members may be interested in updates on: the transfer of CLSI EP37 Supplemental Information on Exogenous substances to an online database, the upcoming webinars, the Introduction of CLSI AUTO11 - Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition. You can find the newsletter here.
Ben Kemp
November 6, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Online course: TOPRA IVD Regulatory Affairs for Global Markets

TOPRA’s Regulatory Affairs for Global Markets course takes place on 19-20 November and will be co-chaired by BIVDA’s Chair of the Regulatory Affairs Working Party, Stuart Angell, and BIVDA alumni, Ashleigh Batchen, now of TUV SUD. This two-day CRED course will cover the latest updates in globalmarkets including the US, Canada, China and Brazil and will also address key areas…
Ben Kemp
November 5, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 28 Oct)

Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: Removed DEU/002/2021/001 (Numed Inc) & DEU/001/2024/001 (Inspire Medical Systems, Inc.) from Open list.Added DEU/001/2024/001 (Inspire Medical Systems, Inc.) to Closed list. Time updated:…
Ben Kemp
November 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 28 Oct)

Transit newsletters – HMRC updates Page summary: Check for the latest updates about moving goods using transit and the New Computerised Transit System (NCTS). Change made: Newsletters ‘October 2024 – NCTS Phase 5: declaring National Transit movements’, ‘October 2024 – NCTS Phase 5: contact details’ and ‘October 2024 – NCTS Phase 5: pre-lodged declarations’ have been added. Time updated: 9:25am,…
Ben Kemp
November 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 28 Oct)

DSIT commercial pipeline, October 2024 Page summary: An overview of the commercial pipeline at the Department for Science, Innovation and Technology (DSIT). Change made: First published. Time updated: 8:49am, 22 October 2024 DSIT commercial pipeline Page summary: A collection of the commercial pipelines published every 6 months for the Department for Science, Innovation and Technology. Change made: Added DSIT commercial…
Ben Kemp
November 1, 2024