MDSAP for medical devices

The Medical Device Single Audit Program allows a quality management system to be assessed for several markets in a single audit. Australia, Brazil, Japan, Canada and the United States take part. An accredited auditor assesses against ISO 13485 using a common model, plus the country-specific requirements of the participating authorities.

The benefit depends on where you sell. In Canada MDSAP is mandatory — no certificate, no licence. The FDA accepts MDSAP reports in place of its own routine inspections, which creates predictability. For Brazil and Japan, separate audits are avoided. Anyone selling only in Europe gains nothing: the MDR is not part of the programme, and the notified body continues to assess independently.

For buyers, an MDSAP certificate at a supplier is a strong signal, because the audit model is process-oriented and run considerably more strictly than plain ISO 13485 surveillance. It still cannot replace your own supplier assessment — here too: read the scope first, then judge.