Global Wireless Regulatory Updates and Trends 2025 Considering regulatory changes early can help simplify your wireless product’s design, testing and certification processes — keeping your launch timeline on track. Watch our on-demand webinar to receive the latest compliance updates impacting market access for Bluetooth, Wi-Fi, Cellular and short-range devices in Africa, Europe, Latin America, North America, the Middle East and Asia. What you’ll learn: Key…
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Dear members, please let me know via regulatory@bivda.org.uk any feedback to the TGA Australia - Proposed amendments relating to transparency of disruptions to supply of medical devices. Consultation closes 20th Feb 2026. TGA want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices. Consultation: Improved sharing of information about medical…
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CLSI MM19 provides comprehensive recommendations for molecular diagnostic testing, that cover strategic planning, regulatory requirements, implementation, quality management, and special considerations for subspecialties of molecular genetics including infectious diseases, oncology, malignant hematology, and pharmacogenetics.
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TGA are updating their website: details can be found here.
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CLSI have a new guidance out CLSI M67: Clear Guidance for Microbiology Laboratory Automation: M67 | Verification of Laboratory Automation in Microbiology
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BIVDA member Qserve is running EU AI act literacy training that may be of use to members. The EU AI Act requires AI literacy training for staff developing and deploying as well as those using AI. AI Literacy - Questions & Answers | Shaping Europe’s digital future
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Qserve perspective on the new Australian TGA UDI requirements. Increasingly relevant as Australia is one of the countries MHRA have identified from international recognition under the proposals for the Pre-Market SI. *Please note, the above post on TGA UDI requirements shows the timelines table for medical devices rather than the IVD table as below. TGA UDI Timelines for IVDs…
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Swissdamed medical device registration now available. Currently voluntary, but mandatory use will apply from 1 July 2026: New in swissdamed: Medical device registration now available
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An update from Swissmed on the requirements for CH REPs etc regarding procedure packs: Information sheet systems and procedure packs
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I am writing to share a meaningful change coming to The Journal of Applied Laboratory Medicine (JALM). Starting with the January 2026 issue, JALM will become a fully open access journal. This new publishing model means changes for both authors and readers. What does this mean for you? Every article will be available for anyone to read, immediately upon publication—no subscriptions required, no login…
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You can find the latest updates here.
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New TGA Australia guidance on understanding regulatory requirements for IVD companion Diagnostics (CDx): https://www.tga.gov.au/resources/guidance/understanding-regulatory-requirements-vitro-diagnostic-ivd-companion-diagnostics-cdx
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Just Published! POCT16, 1st Edition Emergency and Disaster Point-of-Care Testing In crises, every second counts. CLSI POCT16 delivers practical, step-by-step guidance for using point-of-care testing (POCT) devices in emergency, disaster, and urgent care settings—helping teams respond faster, more effectively, and with confidence. Streamlined protocols for high-stress environments Improve patient care during disasters and outbreaks Support regulatory readiness and…
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New request for proposal! FIND are seeking a manufacturing partner for a lateral flow test reader for a multiplex semi-quantitative malaria test with a focus in low- and middle-income countries. Application deadline: 6 June 2025, 23:59 (CET) - Calls for partners - FIND
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WHO recently published a revised guidance and application form for reporting changes to WHO prequalified and emergency use listed in vitro diagnostic (IVD) products. A webinar introducing the new guidance took place on 19 May 2025 and gathered over 120 participants. If you couldn’t attend the webinar but are interested in this subject, please access the webinar recording https://who.zoom.us/rec/share/omC-19wYnD1iXMZtP_qbYNmvfEMNBzsMLxl4cuSqEhpVrgoksqf2nLfrUw1IZhKS.VcSuOwaoh6vk1IirPasscode: 7YK=s?3=…
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