Project record
- Case reference
- ST-024
- Target market
- Australia
- Product class
- IVD Class 3
- Our team's work
- Submitted on behalf of clients
- Evidence basis
- Retained certificate, 2 pages
What similar projects should consider
Self-test products also require attention to instructions, user support and conditions attached to the entry. Retain more than the first certificate page.
Individual products still require assessment of intended use, model scope and technical documentation. This case does not replace product-specific classification.
Related services and preparation
- TGA registration consulting and application support
- Australian Sponsor responsibilities and engagement
- Preparing similar products for Australian market entry
- Documents for your first consultation
Certificate preview
Grey areas conceal manufacturer and client information. The document below contains all pages with text and images redacted.
Open the complete redacted certificate (PDF · 2 pages)
