MDSAP Coverage and Multi-Market Device Procurement
Selling the same introducer SKU into four countries sounds efficient until a registration update in one market blocks import in another. MDSAP — Medical Device Single Audit Program — reduces duplicate audits when manufacturers maintain certifications across Australia, Brazil, Canada, and the United States.
What MDSAP does not replace
MDSAP harmonizes audit approach; it does not replace local registration, labeling, or importer-of-record obligations. Your regulatory affairs team still files per country.
Certificate currency checks
Verify MDSAP certificate status during vendor approval and annually thereafter. A lapse mid-contract can freeze shipments during re-audit windows.
Class II and III history
MDD class II and III certifications remain relevant for legacy devices while MDR certification is pending. Map which certificate supports your current import license in EU markets.
Documentation packages per PO
Ask for certificate copies, sterilization summaries, and material declarations bundled per shipment — not ad hoc email attachments after customs holds.
Supplier diversification risk
Dual-site manufacturing (U.S. and Costa Rica) can improve resilience if disclosed change-control rules cover site transfers.
Use MDSAP status as a filter early — before you invest in private-label artwork or clinical evaluations tied to a single supplier.