Expanding into Australia or New Zealand? Navigating the regulatory requirements is manageable, but it is considerably easier with a local regulatory partner who deals with the TGA and Medsafe routinely.
Compliance Management Solutions provides local representation services that help medical device manufacturers achieve market access and then maintain compliance once they have it.
Australia: TGA compliance
- Official Australian Sponsor
- ARTG inclusion support
- Regulatory submissions
- Direct communication with the TGA
New Zealand: Medsafe compliance
- Authorised New Zealand Agent
- Regulatory liaison with Medsafe
- Ongoing compliance management
Across both markets
- Regulatory submissions and registrations
- ARTG inclusion support
- Post-market surveillance
- Adverse event reporting
- Regulatory correspondence with the TGA and Medsafe
- Support for Class I, II, III and IV medical devices
For a confidential discussion about sponsorship or agent services, please contact our regulatory team.