Showing 17–19 of 19 results
Process Package — Vigilance Reporting Japan (PMDA) Complete framework for Japanese medical device vigilance under PMD Act Art. 68-10. Covers the LISTED vs UNLISTED logic (events already in tempu bunsho follow 30-day path; UNLISTED follow stricter 15-day path), causality assessment, mandatory PSB/PSD fax notification for deaths, and tempu bunsho management strategy. What’s included: SOP-VIG-JP Vigilance…
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…
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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