MDSAP Audit Approach (MDSAP AU P0002)
Chapter 4: Medical device adverse events and advisory notices reporting – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C4-T1-AU: Australia: report adverse events and near adverse events to the TGA or the Australian sponsor as soon as practicable through the post-marketing system

What does C4-T1-AU require?

The organisation needs a way to pick out device-related events that could meet a regulator's reporting criteria, review each complaint for reportability, and meet each regulator's timeframes. For Australia, the post-marketing system must pass on, as soon as practicable, information on any malfunction or deterioration in characteristics or performance, any inadequacy in design, production, labelling, instructions or advertising material, or any intended or unintended use that could cause, or could have caused, a patient's or user's death or a serious decline in health, to the TGA or the sponsor (Sch 3 Pt 1 cl 1.4(3)(c) and (3A)); either the manufacturer or the sponsor may report online to the TGA. Clauses: ISO 13485:2016 4.2.1, 7.2.3, 8.2.2, 8.2.3.

Maintained by Gerard Blokdyk

Other controls in Chapter 4: Medical device adverse events and advisory notices reporting – MDSAP Audit Approach (MDSAP AU P0002)

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