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 · PortugalPortugal
Regulation
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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 · PortugalInfarmed launches INOV@INFARMED innovation network and strengthens partnership between science and regulation
Infarmed established a structured collaboration network with academic institutions to advance research in medicines, medical devices, and health technology assessment.
Portugal INFARMED · PortugalNew study by INFARMED and EMA experts analyzes 13 years of clinical trials in Europe
A study by INFARMED and EMA experts analyzes the evolution of medicinal product clinical trials in the EU/EEA between 2013 and 2025 using CTIS and EudraCT data.
Portugal INFARMED · PortugalInfarmed launches digital campaign on condom acquisition safety
Infarmed runs a digital literacy campaign from September to 22 September on safe and informed purchase of condoms as medical devices.
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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