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26 results for: medical devices
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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...

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The Chinese State Council has passed the eagerly anticipated revisions to the PRC’s Regulations for Supervision and Administration of...

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Following the European Commission's (EC) adoption of a proposal for a Regulation on health technology assessment (HTA) in 2018, and the...

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The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad...

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Portugal has recently initiated the 2015/1535 notification procedure of the decree-law ensuring the implementation in the internal legal...

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The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software-based medical devices,...

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Portugal published Law no. 4-C/2021, which transposes the Directive (EU) 2020/2020 from the 7th of December 2020, as regards temporary...

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The European Commission has published a guidance document aiming to further assist manufacturers with understanding how Legacy Devices...

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When the Covid-19 pandemic hit Europe in 2020, the Portuguese Government took the opportunity to establish the health sector as a...

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There was an unprecedented uptake of digital technology in 2020 in the healthcare sector, and 2021 is expected to be no different....