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Regulatory Affairs Newsletter Archive

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

DSIT weekly update (WC 30 Oct)

Please note this is an extract of the original bulletin. Philanthropic partnership unlocks £32 million for the future of best-in-class UK Biobank Page summary: Eric Schmidt and Ken Griffin are being announced as the first members of a new consortium that will shape the future of the best-in-class UK Biobank. Change made: First published. Association of Southeast Asian Nations (ASEAN):…
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November 10, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. 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 Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)
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November 10, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
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November 10, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 30 Oct)

Please note this is an extract of the original bulletin. Industry Minister makes historic visit to Mongolia to boost UK critical minerals supply chains Page summary: Industry Minister Nusrat Ghani is in Mongolia in an historic visit to boost the UK’s critical minerals supply chains. Change made: First published. Smarter regulation Page summary: This page sets out how the UK…
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November 10, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 30 Oct)

Obligations for authorised representatives, importers and distributors The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor. It also…
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November 3, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Sertio Oy designated as EU Notified Body

Sertio Oy from Finland is designated as a notified body under the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVDR). To date, there are twelve notified bodies designated under the EU IVDR. This designation was published on NANDO database on 31 October September 2023. This can be considered as significant news to the European diagnostics industry.
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November 3, 2023
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