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Regulatory Affairs Newsletter Archive

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

Cabinet Office weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with two additions. Customs, VAT and excise UK transition legislation from 1…
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November 17, 2023
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TGA webinar on Australian UDI implementation

The TGA is in the process of establishing the Australian Unique Device Identification Database (AusUDID). The TGA is hosting a webinar to provide an update on the Australian UDI implementation and a presentation on learnings and the real-world benefits of the UDI adoption in the US healthcare system. The webinar is held on 21 November from 11:30am to 12:30pm (AEDT).…
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November 17, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Mandatory digital customs requirements: parcels to Ireland Page summary: This guidance is for businesses looking to send parcels to Ireland from the UK using Royal Mail, Parcel Force and the UK’s nationwide network of Post Offices. Change made: First published. Government slashes up to £1bn a year of business burdens…
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November 17, 2023
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Preparations for Revisions to ISO 13485 – User survey

In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016. The technical committee have launched a survey seeking feedback on the use of the standard for regulatory…
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November 17, 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 17, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

EPSCO meeting to be held on 30 Nov

Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) is the meeting of the EU Ministers of Health. The upcoming EPSCO meeting agenda includes the implementation of IVDR and MDR with information from the French delegation, supported by the Belgian, German, Irish and Italian delegations. EPSCO is the meeting of the EU Ministers of Health. A public debate is proposed.…
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November 17, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 30 Oct)

Please note this is an extract of the original bulletin. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market. Change made: Applications for the Innovative Devices Access Programme (IDAP) pilot now closes 1 November 2023 and…
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November 10, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 30 Oct)

Please note this is an extract of the original bulletin. New £100 million fund to capitalise on AI’s game-changing potential in life sciences and healthcare Page summary: A new mission announced by the Prime Minister will accelerate the use of AI in life sciences to tackle the biggest health challenges of our generation. Change made: First published. AI to speed…
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November 10, 2023
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