ANSM (Frankreich) klärt das Verfahren zur Befreiung von der CE-Kennzeichnung für M…
Am 27. Januar 2025 veröffentlichte die Nationale Sicherheitsagentur für Arzneimittel und Gesundheitsprodukte (ANSM) in Frankreich ein wichtiges Update zum Prozess …
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FDA (USA) Issues Final Guidance on Predetermined Change…
On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Marketing Submission Recommendations for …
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China Approves Carbon Ion Therapy, Marking Cancer Treat…
On September 29, 2024, the National Medical Products Administration (NMPA) approved the registration of the Carbon Ion Therapy System. This …
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Ministry of Food and Drug Safety Revises Guidelines for…
The Ministry of Food and Drug Safety revised the “Innovative Medical Devices Priority Review Guidelines (Guide for Applicants)” …
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European Commission Finalizes Artificial Intelligence A…
The European Commission has officially published the finalized text of the Artificial Intelligence Act (AIA), marking a significant mileston…
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FDA Qualifies Apple Watch AFib History Feature as a New…
On May 1, 2024, the FDA made a significant announcement by qualifying the Apple Watch AFib History Feature as a biomarker test device throug…
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ANVISA Published Regulation For Medical Devices
ANVISA issued Resolution 837/2023 on December 15, outlining updated procedures for clinical investigations supporting higher-risk Medical De…
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Rice-Sized Device Tests Brain Tumor’s Drug Responses …
An NIH-funded team has developed a miniature device with the potential to predict the therapeutic option that will work best for a given tum…
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Brazil CONEP/CNS Publish Guidelines for Ethical Review …
Brazilian National Commission on Ethics in Research – CONEP/CNS has published on its website a Circular Notice, which provides guidance on…
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US FDA Issues Revised Guidance on Qualification of Medi…
This final guidance supersedes Qualification of Medical Devices Development Tools: Guidance for Industry, Tool Developers, and Food and Drug…
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