17 Feb

Next scheduled session on Compliance Training for Medical Devices to be held on 26 April 2017. Bookings essential.

Our next Information Session for Australian Importers/Suppliers of Medical Devices will be held on Wednesday 26 April 2017.

AGENDA

  • Medical devices – definitions, examples
  • Regulatory framework in Australia and the TGA
  • Roles and responsibilities
  • Key regulatory requirements
  • Medical devices with wireless (Bluetooth) and telecom capabilities
  • Medical devices used in patients homes
  • TGA Application process
  • Practical case study: TGA registration for a blood pressure monitor
  • Post TGA registration: ongoing responsibilities for manufacturers and sponsors
  • Changes to TGA registrations
  • Post-market vigilance and annual reporting
  • Medical devices recalls
  • Cancellation of TGA registration

Complete the Booking Form or for further enquiries phone us on 02 9416 0818 or email jane@certificationbody.com.au

 

 

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