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.
Frequently asked questions
What should we do if the product’s regulatory category is unclear?
For borderline products, assess composition or structure, mode of action, intended purpose and claims before choosing a pathway. Products that look similar or share a pharmacy channel may fall into different regulatory categories. Provide labels, instructions, composition or design information and proposed promotional materials, together with the country and use setting. An initial category assessment and list of open questions can guide evidence and specialist support instead of starting with an unsuitable registration checklist.
Can Australia and Canada use the same product preparation documents?
Base product information can be shared across Australian and Canadian planning, but assess regulatory category, classification, responsible entities and evidence requirements separately. One country’s conclusion does not automatically apply in the other. Build a common document inventory with country-specific intended use, labels, entities and unresolved issues. This reduces duplicate preparation while exposing local gaps. Sequence the projects according to evidence, commercial priorities and resources rather than assuming simultaneous applications are necessary.
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.
