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19 results for: regulation-devices
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In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...
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Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
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As previously shared when the new regulatory framework for software as a medical device (“SaMDs”) was presented earlier this year (here),...
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Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR...
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The European Commission recently adopted two new regulations laying down rules for the application of Regulation (EU) 2017/746, as...
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On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the "Act"). It was signed by the President on 20...
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HealthTech: Trends and Challenges  In a recent internal webinar, DLA Piper and Global Data looked into the shifting landscape of...
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In late February, 2022 the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical...
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With Circular 0081386 dated 12 November 2021, the Italian Ministry of Health confirmed that the national pre-authorization requirements...
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Portugal initiated the 2015/1535 notification procedure of the decree-law establishing the rules applicable to the reprocessing and...
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BackgroundThe Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
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New EU regulations governing medical devices and in-vitro diagnostic devices were introduced in May 2017 - the Medical Devices Regulation...
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In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the...
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Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common...
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The Chinese State Council has passed the eagerly anticipated revisions to the PRC’s Regulations for Supervision and Administration of...