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APHA – Border Trade Newsletter – getting it right at the border 03 07 25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: PHES maintenance Lumpy skin disease in Italy and France Authorised Operator Status (AOS) Pilot FMD…
Ben Kemp
July 10, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

China – standards update for medical devices including IVDs

NMPA China have published a list of updated Medical Device Standards including some for IVDs including: 15 - 17α-Hydroxyprogesterone Assay Kit (Labelled Immunoassay) 17 - Information provided by the manufacturer of the medical device 18 - Motor Neuron Survival Gene (SMN) Assay Kit 19 - Aldosterone Assay Kit (Chemiluminescence Immunoassay) 20 - Colorectal Cancer-relate d Gene Methylation Detection Kit (Fluorescent…
Ben Kemp
July 10, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Airlock round 2 open until 14 July

A reminder for members that applications for the second round of the MHRA AI Airlock programme close on 14 July 2025. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory…
Ben Kemp
July 8, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32024R2847R(02): Corrigendum to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and

Corrigendum to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) View article...
Ben Kemp
July 4, 2025
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