New European regulations updating rules for medical devices enter into force
New European regulations updating medical device rules enter into force on 19 July 2026.
Portugal INFARMED · Portugal
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Portugal INFARMED
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INFARMED guidance on digital health solutions as medical devices
INFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalFrequently Asked Questions on SiNATS Review: First Answers Now Available
INFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalCOMBINE Programme advances to second phase of coordinated assessment pilot project for combined clinical trials
Portugal's INFARMED announces the COMBINE programme has progressed to the second phase of its pilot project for coordinated evaluation of combined clinical trials.
Portugal INFARMED · Portugal
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