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Brazil IVD News: Regulation updates

To help you navigate the Brazilian Health Regulatory Agency's (ANVISA) latest updates for in vitro diagnostics (IVDs) and the implications for your healthcare products, we highly recommend you review this detailed report by Patricia Urakawa, Senior Consultant of Regulatory Affairs at Emergo by UL. This invaluable resource explains several critical updates to RDC 830/2023 that you should be aware of,…
Ben Kemp
October 15, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32024D2657: Council Decision (EU) 2024/2657

Two new harmonised standards have been added for IVD under the EU IVD regulation. In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added: No ‘14. Reference of the standard EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) No ‘15. EN ISO 20916:2024 In vitro diagnostic medical devices –…
Ben Kemp
October 15, 2024
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EPO free online event

Patents and innovation in European universities The IPO UK has contributed to a European Patent Office (EPO) “Patents and innovation in European universities” study. On the 22 October the EPO’s Observatory on Patents and Technology will be hosting an online event on technology transfer and academic innovation in Europe, to mark its first anniversary. This event brings together key stakeholders…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Section 524B: Navigating Healthcare Cybersecurity Compliance – Webinar

The intersection of healthcare and cybersecurity has become a critical bridge in safeguarding patient data and ensuring the integrity of medical technologies. Unpack the complexities of Section 524B, a key legislative directive aimed at fortifying cybersecurity measures within the healthcare sector. You’ll gain insights, get strategic advice, and learn practical steps for complying with Section 524B for medical software development…
Ben Kemp
October 9, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade (WC 7 October)

Notice to exporters 2024/26: update on Russia sanctions licensing for intra-corporate services Page summary: The government his removing the licensing consideration from 31 October 2024. Change made: First published. Time updated: 9:30am, 30 September 2024 Notices to exporters Page summary: Notices to exporters published by the Export Control Joint Unit (ECJU). Change made: NTE 2024/26 been added collection. Time updated:…
Ben Kemp
October 9, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Update (WC 7 October)

Sweden: Italy: UK Science and Innovation Network Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in Sweden including UK SIN priorities and successes. Change made: Summary fully reviewed and updated. Time updated: 8:19am, 30 September 2024 Cyber Security and Resilience Bill Page summary: The forthcoming Cyber Security and Resilience Bill will improve UK…
Ben Kemp
October 9, 2024
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