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Regulatory Affairs Newsletter

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

MHRA weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Guidance updated to reflect the latest information regarding the MORE portal. COVID-19 test validation approved products Page summary: Find out which…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance: call for evidence* Page summary: We are seeking views on the Code on Genetic Testing and Insurance, to help us decide whether it may need to be revised to ensure it remains beneficial to both consumers and the insurance industry. Change made: First published.…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Joint outcome statement: UK-India round eleven FTA negotiations Page summary: Round eleven of negotiations for a free trade agreement between the United Kingdom and the Republic of India Change made: First published. Training on export control compliance Page summary: Courses, seminars, workshops and webinars to help exporters understand their obligations…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Research Ventures Catalyst: open for applications Page summary: A pilot programme that will stimulate the creation of novel research ventures, via entrepreneurial team-based approaches in collaboration with partners drawn from the public sector, industry and the third sector. Change made: Research Ventures Catalyst open for applications question and answer document…
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August 4, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 24 July)

Please note this is an extract of the original bulletin. For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and…
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August 4, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 24 July)

Please note this is an extract of the original bulletin. MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Mutual recognition in principle of inspections by Swissmedic and the FDA. The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Extension of CE mark recognition in Great Britain for certain products

The UK Government have announced that recognition of the CE mark for most goods will be continued indefinitely, beyond December 2024. This applies only to the 18 regulations falling under the Department for Business and Trade (DBT), covering a range of products: toys pyrotechnics recreational craft and personal watercraft simple pressure vessels electromagnetic compatibility non-automatic weighing instruments measuring instruments measuring…
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August 4, 2023
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