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In the current issue of the JMDR...

  • Australia: the Government's response and industry's reaction to the medicines and medical devices regulation review in Australia
     
  • 3D printing: a summary of the US FDA's proposed draft guidance on additive manufacturing and 3D printing, plus industry's perspectives on the draft guidance
     
  • UDI: the important lessons for Europe from the USA's implementation of UDI, and the benefits of prompt compliance
     
  • China RoHS: a practical look at the key updates introduced by China's Restriction of Hazardous Substances (RoHS) Regulation 2.0 in 2016
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Colombia, Egypt, the European Union, Germany, India, International, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, and the USA
     
  • Country overview: summary of the regulatory requirements for medical devices and IVDs in Kenya
     
  • Book review: Handbook of Cardiac Anatomy, Physiology and Devices, Third Edition
     

In the previous issue of the JMDR...

  • Brexit: how the UK's vote to leave the EU may affect the medical device industry
     
  • European MDR & IVDR: adoption of the compromise agreements on the new European Regulations for medical devices and in vitro diagnostics
     
  • PMS: meeting post-market surveillance requirements in today's turbulent regulatory waters
     
  • Software: software, apps and big data pose new health regulatory challenges for Europe
     
  • Audits: a European Competent Authority perspective on the most common deficiencies in medical device manufacturer audits
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Ecuador, the Eurasian Economic Union, the European Union, France, Germany, India, Israel, Korea (Republic of), Lithuania, Malaysia, Saudi Arabia, Singapore, the UK, the USA and Vietnam
     
  • Country overview: summary of the regulatory requirements for medical devices and IVDs in Pakistan