MDSAP Readiness: A Practical Checklist

The Medical Device Single Audit Program (MDSAP) allows a single audit to satisfy the regulatory requirements of five participating authorities: FDA (United States), Health Canada, ANVISA (Brazil), TGA (Australia), and PMDA (Japan). For manufacturers selling in multiple of these markets, MDSAP can significantly reduce audit burden.

Preparation requires understanding how MDSAP auditors sequence their review — they follow a defined audit model that connects processes across the organization. Gaps in design controls, for example, ripple into risk management and production records. Auditors are trained to trace these connections, so isolated remediation is rarely enough.

Key readiness areas include management responsibility documentation, complete design history files, robust supplier qualification records, and a CAPA system with demonstrated effectiveness. Run an internal mock audit using the MDSAP audit model before your first official cycle. Identify findings in your own terms before an auditor does.