MDSAP Audit Approach (MDSAP AU P0002) C2-T3-AU: Identify changes needing regulatory notification and, for Australia, notify the MDSAP auditing organisation (and the TGA for conformity assessment certificate holders) before substantial QMS, supplier, process, scope or Class III design changes

What does C2-T3-AU require?

The organisation must identify which changes to marketed devices or the QMS need notification, paying special attention to design changes. Because the TGA recognises MDSAP auditing organisations to perform QMS assessments for it (Reg 3.5), the manufacturer must notify its auditing organisation of proposed changes to the QMS (including manufacturer name or location), critical suppliers or what they supply, validated manufacturing processes, the kinds of devices covered, and, for Class III devices or Class 4 IVDs, any change to design, intended performance or user, packaging, or storage and transport conditions; the auditing organisation decides whether a special audit is needed. A TGA conformity assessment certificate holder must also notify the TGA before implementing substantial changes (for example manufacturer details, facility scope, critical processes such as drug coating or sterilisation, critical suppliers, conformity procedure, device category, design or the information supplied with the device). ARTG and certificate-validity notifications are the sponsor's. The certification contract obliges the organisation to tell the auditing organisation without delay of matters affecting the QMS (ISO/IEC 17021-1 cl 8.5.3). Clauses: ISO 13485:2016 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3, 7.3.9; TG(MD)R Reg 3.5.