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Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program
  • Hogan Lovells
  • USA
  • September 11 2018

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market

US House Votes to Repeal Medical Device Excise Tax
  • Morgan Lewis
  • USA
  • September 4 2018

While the US House of Representatives recently voted to repeal the medical device excise tax imposed by a 2010 amendment to the Affordable Care Act

Solicitation on the management of agents of imported medical devices
  • CMS
  • China
  • September 3 2018

CNDA released the Measures for the Supervision and Administration of Agents of Imported Medical Devices (Draft for Comment) ("Draft") on 2 August 2018

Small but mighty: Medical device technology punching above its weight
  • Barker Brettell LLP
  • United Kingdom
  • August 23 2018

From tongue depressors to MRI machines to pace makers, the range of medical devices sold is vast. Today, the development of medical devices is

Getting ready for the EU MDR: Requirements for identification and traceability of medical devices
  • Allen & Overy LLP
  • European Union
  • August 20 2018

In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that

New MHRA guidance on Brexit implementation period and the lifesciences sector
  • CMS
  • United Kingdom
  • August 15 2018

On 6 August 2018, the MHRA released new guidance on what the Brexit implementation period means for the lifesciences sector, as well as an update on

SaMD Series: What Should Life Sciences Companies Know?
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • August 14 2018

Software as a Medical Device - also referred to as SaMD - is one of the fastest growing innovations in the medical device industry. As with any

Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come

Brexit, medical devices and transfer of notified bodies. What will be the procedure?
  • Hogan Lovells
  • United Kingdom, European Union
  • August 7 2018

In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common

Medical devices industry calls for more time to implement EU Medical Devices Regulation
  • Allen & Overy LLP
  • European Union
  • August 7 2018

MedTech Europe, the European trade association representing the medical technology industries, has called on the European Commission, European