In the current issue of the JMDR...

  • EU MDCG: Europe's Medical Device Coordination Group (MDCG) - a successor to the MDEG or a new CHMP in the making?
     
  • Brazil: What changes are expected in 2018 for Brazil's medical device regulations?
     
  • Risk management: A review of ISO/TR 24971:2013 concerning the application of ISO 14971 for the risk management of medical devices
     
  • Singapore: An overview of the regulatory requirements that apply to medical devices in Singapore
     
  • Lithuania: A summary of the regulatory requirements that apply to medical devices and in vitro diagnostic medical devices in Lithuania, written by the Competent Authority
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory news updates in Australia, Brazil, Canada, China, the EAEU, the European Union, Finland, India, International, Israel, Japan, Kenya, Korea, Malaysia, Pakistan, the Philippines, Saudi Arabia, Switzerland, the USA and Vietnam
     
  • EU Regulations: Roadmap for implementation of the new European Regulations on medical devices and in vitro diagnostics (MDR / IVDR)
     

In the previous 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 news updates in Australia, Brazil, Canada, China, Ecuador, the European Union, France, India, Israel, Korea, Malaysia, Russia, Saudi Arabia, Singapore, the UK, and the USA