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Regulatory Affairs Newsletter

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QServe and TUV SUD – Navigate AI in MedTech: Live Regulatory Insights

We'd like to invite you to a live, practical webinar on Ensuring Quality in AI Driven Devices, hosted by Qserve experts and a guest speaker from Notified Body TÜV SÜD. We will unpack the regulatory expectations, explain what TÜV SÜD assesses during a submission review, and share examples from real-world cases, including those involving AI-supported clinical evaluation activities. Thursday, January 29,…
Ben Kemp
January 23, 2026
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MedTech Europe update on EUDAMED progress

Mandatory use of the first four EUDAMED modules (Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance) starts as of 28 May 2026 EUDAMED PLG v3.22 released on 12 December: This release includes updates reflecting feedback from the VGL CA Board’s coordinated testing. According to the release notes, it is now possible to change the referenced device in…
Ben Kemp
January 23, 2026
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The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The Therapeutic Goods Administration (TGA) has released its compliance principles for the next 2 years, setting out a refreshed approach to compliance and enforcement to protect public health. The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for…
Ben Kemp
January 23, 2026
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2025: Global Wireless Regulatory Overview

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…
Ben Kemp
January 23, 2026
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Join Us: Shaping the Future of Clinical Trials in the Philippines – Exclusive Webinar

Dear Partners, We are delighted to invite you to our upcoming webinar, “Shaping the Future of Clinical Trials in the Philippines,” hosted by the IQVIA Philippines team. Date: Wednesday, February 4, 2026 Time: 9:30 pm – 10:30 pm SGT | 9:30 am – 10:30 am EST Join us for an insightful session featuring distinguished speakers from the Department of Health, Philippines FDA, and leading…
Ben Kemp
January 23, 2026
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IPO fees to increase from 1 April 2026

IPO fees to increase from 1 April 2026 We wrote to you in November announcing a fee increase across all IP rights, due to come into effect on 1 April 2026, subject to parliamentary approval. Fees will be increasing by an average of 25%. For example, a patent search is going up from £150 to £200 and a trade mark…
Ben Kemp
January 23, 2026
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Enhancing collaboration for health security

Enhancing collaboration for health security Enhanced cooperation was at the forefront of the Health Security Committee (HSC) plenary in Brussels on 14-16 January 2026, with discussions focussed on enhancing health security preparedness and protecting citizens. The meeting took place back-to-back with a meeting of the G7 Global Health Security Initiative, highlighting the benefits of global collaboration in the face of…
Ben Kemp
January 23, 2026
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