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Ben Kemp

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA fees 1st Oct 2025 to 30 Sep 2026

FDA have announced their user fess for financial year 2026. The fees will apply from 1st Oct 2025 until 30th Sep 2026. The FDA Annual Establishment Registration Fee stands at $11,423. Under the Small Business Determination (SBD) Program, small businesses able to demonstrate financial hardship according to FDA, the FDA has discretion to waive the annual establishment registration fee. This…
Ben Kemp
September 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Wales – Prohibition of Import for Personal Use or Consumption

Please be advised that new order applicable to Wales prohibits the import of certain goods (See article 2) for personal use or consumption, including animal-by-products. The Animal Health (Import Controls) (Wales) Order 2025 This Order prohibits the importation into Wales of products from susceptible animals (defined in article 2 of this Order) which are intended for personal consumption or use.…
Ben Kemp
September 8, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EN IEC 63366:2025

Standard for conducting LCAs for Electrical and Electronic Equipment. Not sure if there is work ongoing separately for a MD or IVD LCA.   EN IEC 63366:2025 - Product category rules for life cycle assessment of electrical and electronic products and systems (publication date=2025-08-01) View article...
Ben Kemp
September 8, 2025
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