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  • TGA ARTG SOP + Pathway Selection Template — Australia

    TGA ARTG SOP + Pathway Selection Template — Australia

    €69.00

    Process Package — Marketing Authorization Australia (TGA) Complete framework for Australian TGA ARTG inclusion. Covers Sponsor designation, classification under TG (MD) Regulations 2002, the five conformity assessment pathways, Essential Principles (Schedule 2), AusUDID (effective 2025), and Annual Reports for ARTG-included devices. What’s included: SOP-REG-AU Marketing Authorization Australia — full procedure: Sponsor designation, classification rules, 5…

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  • TGA MDIR SOP + Exemption Worksheet — Australia

    TGA MDIR SOP + Exemption Worksheet — Australia

    €69.00

    Process Package — Vigilance Reporting Australia (TGA) Complete framework for Australian medical device incident reporting. Covers Medical Device Incident Report (MDIR) under TG (MD) Regulations 2002, the Australia-specific exemption mechanism (events that meet specific criteria can be aggregated in Annual Reports rather than reported individually), and the PRAC (Procedure for Recalls, Product Alerts and Product…

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