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.
- 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