Background

The Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...

In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...

New EU regulations governing medical devices and in-vitro diagnostic devices were introduced in May 2017 - the Medical Devices Regulation...

In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the...

Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common...

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...

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

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

In this month's 'Russia Pharmaceuticals Sector Update', Julien Hansen, Elena Mikhailovskaia and Pavel Arievich of DLA Piper's Moscow...

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