In the current issue of the JMDR...

  • EU combinations: The impact of the new Medical Device Regulation on device/drug and drug/device combination products in Europe
  • PMS in Brazil: Post-market surveillance requirements applicable to medical device and IVD product licence holders in Brazil
  • MDSAP: Understanding the Medical Device Single Audit Program (MDSAP) and its implications for manufacturers
  • HTA in Europe: Closing the gap between regulatory and HTA requirements for approval and reimbursement of high-risk medical devices in Europe
  • Canada: An overview of the regulatory requirements that apply to medical devices and in vitro diagnostic (IVD) devices in Canada, reviewed and approved by Health Canada's MDB
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Ecuador, the European Union, France, India, Israel, Korea, Malaysia, Russia, Saudi Arabia, Singapore, the UK, and the USA

In the previous issue of the JMDR...

  • USA: Can the US FDA be brought 'back to the future'?
  • Europe: The challenges in implementing the new European medical device and IVD Regulations
  • Europe: The HPRA in Ireland presents its perspective on the new European medical device and in vitro diagnostic legislation with practical advice for manufacturers and Notified Bodies
  • Economic Operators: A discussion of the Economic Operators in the new European Regulations on medical devices and in vitro diagnostics
  • India: Highlights of India's Medical Devices Rules, 2017
  • Ecuador: An overview of the laws and regulations for medical devices in Ecuador
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Argentina, Australia, Brazil, China, the EAEU, Egypt, the European Union, Hong Kong, India, Ireland, Japan, Kazakhstan, Kenya, Korea, Malaysia, Netherlands, Norway, Peru, Philippines, Saudi Arabia, Singapore, Taiwan, Turkey, the UK, and the USA