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