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FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 23 Oct)

Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be covered under the requirements of Food, Drug and…
admin
October 27, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Science, Innovation and Technology

Code of practice for app store operators and app developers Page summary: This code of practice sets out minimum security and privacy requirements for app store operators and app developers. Change made: An updated version of the Code of Practice has been added to this page. This is the latest version.
Dawn
October 20, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Animal and Plant Health Agency

Export of non-ruminant processed animal proteins and rendered fats not intended for human consumption to Chile: certificate 8713 updated Page summary: Apply online to export non-ruminant poultry, porcine and equine PAPs derived from protein, including pure or mixed viscera meals, meat and bone meal, feathermeal and oils or fats to Chile not intended for human consumption. Change made: Guidance notes…
Dawn
October 20, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Environment, Food & Rural Affairs

Import risk categories for animals and animal products imported from the EU to Great Britain, from 31 January 2024 Page summary: Import risk categories under the Border Target Operating Model (TOM) for animals or animal products you’re importing from the EU to Great Britain (England, Scotland and Wales), and the import rules for each category. Change made: We’ve updated the…
Dawn
October 20, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Business and Trade

Note: The comment under UKCA marking (excluding medical devices etc.) that if UK Designated standards have restrictions that aren’t included in the EU Harmonised standards, then designated standards take precedent, even though they’re not recognised for CE conformity assessment. See sector guidance for further details.   This means that although CE marked goods are recognised for the GB market, Manufacturers/Importers…
Dawn
October 13, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Environment, Food & Rural Affairs

Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU.   Accredited Trusted Trader Scheme pilot Page summary: How to…
Dawn
October 13, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Science, Innovation and Technology

  New £60 million Regional Innovation Fund among measures to boost research and development Page summary: A £60 million Regional Innovation Fund (RIF) that will boost support for universities in areas with lower levels of R&D investment is among new measures Technology Secretary Michelle Donelan has announced.  
Dawn
October 13, 2023