Project record
- Case reference
- ST-020
- Target market
- Australia
- Product class
- MD Class IIb
- Our team's work
- Submitted on behalf of clients
- Evidence basis
- Retained certificate, 1 page
What similar projects should consider
Intended use and duration of implantation affect regulatory assessment. Endoscopic accessories should not all be assigned the same risk class.
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
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Open the complete redacted certificate (PDF · 1 page)
