Start with intended use and classification
Products with the same appearance or technology may fall under different rules because of intended use, method of use or contact duration. First establish device status, then apply classification rules. Common non-IVD classes include I, IIa, IIb and III, with additional requirements for particular categories.
Connecting existing authorizations with Australian requirements
Overseas approvals or certifications may form part of the evidence review but do not automatically confer Australian market access. Check scope, models, manufacturer and intended use to identify documents usable under the applicable Australian pathway.
How Sonictec can help
Discuss classification and pathways, review manufacturer documents, technical files and clinical evidence, coordinate manufacturer/Sponsor roles, and progress agreed applications and follow-up.
Frequently asked questions
What product information is needed to classify a medical device?
Classification starts with intended use and the applicable rules, considering features such as active operation, body site, invasiveness and duration of contact. A product name or overseas class alone is insufficient, and overlapping rules must be addressed. Provide instructions, product images and a use workflow to explain how the device operates. The classification rationale should align with labelling and technical information because it informs evidence, application and maintenance planning.
Official sources:TGA: classification of non-IVD medical devices
Checked:
Can a main device, accessories and consumables be treated as one product?
Identify the purpose and supply arrangement of each accessory or related product rather than assuming it inherits the main device’s class or entry because they are sold together. TGA guidance distinguishes accessories, combinations and systems or procedure packs. Prepare a configuration matrix showing separate sale, function, manufacturer and relationship to the main device, then assess classification and application arrangements so independently regulated products are not overlooked.
Official sources:TGA: classification of non-IVD medical devices
Checked:
Official references
- TGA: steps to supply medical devices for Sponsors
- TGA — Classification of medical devices (not IVDs)
- TGA: using assessments from comparable overseas regulators
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.
