Compliance does not stop at market entry. As a TGA sponsor you are required to actively monitor, report on and maintain the ongoing safety and performance of your medical device. These obligations continue for as long as the device is supplied.
Where sponsors most often need support
- Adverse event and vigilance reporting
- Complaint handling systems
- CAPA management
- Post-market surveillance documentation
- Annual reporting obligations
- Technical documentation maintenance
- Continuous regulatory compliance support
Post-market obligations are the ones most likely to drift quietly, because nothing external forces the issue until an inspection or an incident does. Compliance Management Solutions supports sponsors with end to end post-market compliance so that the system stays current rather than being reconstructed under pressure.
To review your post-market obligations, please contact our regulatory team.