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An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
Cortex - Life Sciences Insights
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medical devices
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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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I saw this recent article highlighting the need for the UK to create a much more supportive and sustainable environment for life sciences...
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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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Background
The Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
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In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...
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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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On 30 June 2021, a draft bill amending the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs for Special Nutritional...
The Chinese State Council has passed the eagerly anticipated revisions to the PRC’s Regulations for Supervision and Administration of...
Following the European Commission's (EC) adoption of a proposal for a Regulation on health technology assessment (HTA) in 2018, and the...
The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad...
Portugal has recently initiated the 2015/1535 notification procedure of the decree-law ensuring the implementation in the internal legal...
The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software-based medical devices,...
Portugal published Law no. 4-C/2021, which transposes the Directive (EU) 2020/2020 from the 7th of December 2020, as regards temporary...