Process Package — Vigilance Reporting Brazil (Notivisa) Complete framework for Brazilian medical device vigilance. Covers RDC 67/2009 reportability assessment, Notivisa submission, causality classification, foreign event tracking, and field actions. What’s included: SOP-VIG-BR Vigilance Reporting Brazil — full procedure with the 4-question reportability framework per RDC 67/2009, Notivisa submission process, causality classification, timelines (10 days for…
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 — 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…
