Articles

If you are planning to supply medical devices in Australia, understanding the Therapeutic Goods Administration (TGA) medical device registration costs and timelines is essential for effective market entry.In 2025, the TGA continues to apply a risk-based approach to device regulation, meaning costs and approval timelines vary depending on the classification of your device, your evidence of conformity, and whether you choose the TGA Conformity Assessment or Mutual Recognition pathway. At OMC Medic...

If you’re planning to supply a medical device in Australia, you must comply with the Therapeutic Goods Administration (TGA) requirements and have your product included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally marketed.  In this blog post, we will walk you through the step-by-step process for medical device registration in Australia in 2025 — from device classification to post-market obligations — so you can navigate TGA regulations with confidenc...