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-T2-AU: Australia: tell the TGA or the sponsor as soon as practicable when the manufacturer proposes to recall devices distributed in Australia, with the technical or medical reasons

What does C4-T2-AU require?

Advisory notices must be reported to regulators when necessary, within their timeframes and with the required records. For Australia, the post-marketing system must inform the TGA or the sponsor as soon as practicable once the manufacturer plans to recall devices that were supplied in Australia, including the technical or medical reason for the malfunction or deterioration behind the decision (Sch 3 Pt 1 cl 1.4(3A)); the information behind the decision is reported as soon as the manufacturer knows, not after investigations and corrective actions are complete. Conducting the recall in Australia is mainly the sponsor's duty under the TGA's recall procedure (PRAC). Clauses: ISO 13485:2016 4.2.1, 7.2.3, 8.2.3, 8.3.3.

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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