Kapazitätsverlust durch doppelte Meldungspflichten (Hersteller, Sponsor, Krankenhäuser)

Definition

The Therapeutic Goods Act 1989 was amended so that all Australian public, private, and day hospitals must report device‑related adverse events to the TGA, with the CEO of each facility responsible for compliance, supported by the new Adverse Signal Detection and Event Reporting (ASDER) system.[3] In parallel, sponsors and manufacturers are already obliged under the Therapeutic Goods (Medical Devices) Regulations 2002 and ARGMD to report adverse events and maintain post‑market surveillance.[1][4][5] This dual‑channel reporting means the same clinical incident often triggers an internal hospital report, an ASDER submission, a sponsor complaint, and an MDR report, each requiring separate data entry, clinical and technical review, and documentation.[1][3][4] In the absence of integrated data sharing or standardised interfaces, manufacturers must spend additional time reconciling divergent data between hospital reports and their own complaint records to avoid duplicate or inconsistent MDR submissions, reducing capacity for proactive quality improvement. If a manufacturer handles 200–400 adverse event complaints from Australian hospitals annually and spends an extra 1–2 hours per case on reconciliation and duplicate processing, this represents 200–800 hours per year; at an average specialist cost of AUD 80–120 per hour, this equates to AUD 16,000–96,000 in avoidable capacity loss (logic derived from overlapping legal obligations and typical review effort).

Why This Matters

The Pitch: Medical device manufacturers in Australia 🇦🇺 can lose hundreds of specialist hours annually reconciling hospital, sponsor, and manufacturer reports for the same events. Shared, automated complaint and MDR workflows can recover 30–40% of this capacity.

Affected Stakeholders

Post‑Market Surveillance Specialist, Regulatory Affairs Specialist, Hospital Risk/Quality Manager (customer side), Clinical Support Specialist, Field Service Engineer (data collection)

Related Business Risks