Establish which rules apply to the product
Healthcare products may fall under medical device, IVD, medicine or other frameworks. A name, sales channel or overseas classification does not directly establish Australian requirements. Assess intended use, composition, mode of action and claims.
Organise existing evidence into a basis for discussion
Product descriptions, labels and instructions, ingredients or main components, intended use and existing authorizations help identify questions needing review. Detailed files can be exchanged after scope is agreed.
Define scope around the product
Sonictec can discuss Australian market entry, applicable registration support and local commercial collaboration. Specific regulatory tasks and deliverables are confirmed after product assessment.
Official references
- TGA — Overview of medical devices and IVD regulation
- TGA: steps to supply medical devices for Sponsors
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.