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Regulatory Affairs Newsletter

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Town Hall – FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections

Town Hall – FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties to discuss the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850), effective February 2, 2026. This CP includes the new inspection process, which aligns with…
Ben Kemp
March 13, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates: WC 8th March

Landmark consultation seeks views on major measures to protect children on social media, gaming platforms and AI chatbots Page summary: Government launches a landmark consultation on UK children’s digital wellbeing, covering social media age bans, curfews, AI chatbots and gaming. Change made: First published. Time updated: 12:01am, 2 March 2026 Online Safety Act Page summary: The Online Safety Act received…
Ben Kemp
March 13, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates: WC 8th March

Import controls Page summary: How to import goods under national or UN-level import controls. This includes weapons, sanctioned goods, or goods that could be used for torture. Change made: Notice to Importers 2956 ‘Import of equipment that could be used for torture’ was added to the page. Notice to Importers 2938 was removed as this has now been superseded by…
Ben Kemp
March 13, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates: WC 8th March

Animal diseases: international and UK monitoring Page summary: Monitoring for major, notifiable or new and emerging animal disease outbreaks internationally and in the UK. Change made: Added Preliminary Outbreak Assessment detailing a Rabies case in a dog in Germany. Time updated: 10:13am, 2 March 2026 Check if you need an environmental permit Page summary: When you may need an environmental…
Ben Kemp
March 13, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Estimating detriment from unsafe and non-compliant products

Estimating detriment from unsafe and non-compliant products Page summary: A report on the development of an economic model to estimate consumer and business detriment caused by unsafe and non-compliant products on the UK market. Change made: First published. Time updated: 11:38am, 5 March 2026
Ben Kemp
March 13, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates: WC 8th March

Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated the list of professionals who can certify export health certificates in England. Time updated: 9:48am, 2 March 2026 Animal diseases: international…
Ben Kemp
March 13, 2026
Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates: WC 8th March

Changes to NICE regulations: cost-effectiveness threshold Page summary: Consultation seeking views on proposals to give ministers limited powers to direct the National Institute for Health and Care Excellence (NICE) in setting the standard cost-effectiveness threshold. Change made: Added the government response to the consultation. Time updated: 4:58pm, 3 March 2026 England Rare Diseases Action Plan 2026 Page summary: The fifth…
Ben Kemp
March 13, 2026
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HRA Now – New process to make it easier to set up research involving health and social care staff as participants

What: we are introducing a new proportionate process to make it easier to set up research involving health and social care staff as participants in the UK Who: sponsors, researchers, NHS and HSC organisations in England, Wales, Scotland and Northern Ireland When: the new process comes into effect on Tuesday 10 March 2026 We are introducing a new process to help streamline the application…
Ben Kemp
March 13, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For Review by 11 March: Weekly ECHA Substance Evaluations

Dear members, please see below MedTech Europe update, if your impacted please let me know at regulatory@bivda.org.uk We would like to inform you about the latest chemical developments at ECHA and kindly ask you to indicate if any of the following impact your company by 11 March. Please note that the substances highlighted in yellow are the ones previously identified as…
Ben Kemp
March 9, 2026
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The Medical Devices (Fees Amendment) Regulations 2026

Dear members, as previously discussed regarding the changes to the MHRA fees, the proposal has now been adopted in law, amending the UK MDR 2002 (as amended) and the Medical Device (Northern Ireland Protocol) Regulations 2021 The Medical Devices (Fees Amendment) Regulations 2026 These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”) and the Medical Devices…
Ben Kemp
March 9, 2026
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