Medical Device Sponsorship In Australia

To legally supply a medical device in Australia, the product must be included in the Australian Register of Therapeutic Goods (ARTG). For overseas manufacturers, this requires appointing an Australian-based medical device sponsor. DTS Regulatory Consultants provides experienced sponsorship and regulatory support to help manufacturers meet Therapeutic Goods Administration (TGA) requirements efficiently and compliantly.

As the sponsor, DTS acts as the primary regulatory contact with the TGA. We manage ARTG applications, ensure correct device classification, and confirm that conformity assessment evidence and technical documentation meet Australian regulatory standards. Our consultants also verify that labelling, instructions for use, and advertising claims comply with applicable legislation and the Essential Principles for safety and performance.

Sponsorship responsibilities extend beyond initial ARTG inclusion. DTS supports ongoing compliance by maintaining ARTG records, managing annual charges, reporting adverse events, and coordinating recalls or corrective actions where required. We also assist with change notifications, such as updates to manufacturers, device design, or intended purpose, helping to minimise regulatory risk and disruption to supply.

With over 30 years of regulatory experience across medical devices and therapeutics, DTS offers a collaborative, practical approach to medical device sponsorship. Partnering with DTS gives manufacturers confidence that their Australian regulatory obligations are met—allowing them to focus on commercial growth while maintaining compliance.