TGA registration support for medical devices

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.