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Medical Device Consultant.MY
MDSAP · USA · Canada · Brazil · Australia · Japan

One audit. Five markets. No repeated theatre.

The Medical Device Single Audit Program lets a Malaysian manufacturer prove its quality system once — to an audit accepted in the USA, Canada, Brazil, Australia and Japan. If export is the plan, this is the efficient rung.

ISO 13485 first
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Where it fits

The bridge between your QMS and your export markets

MDSAP sits deliberately at stage four of our export ladder: it presumes a working ISO 13485 system (stage three) and it feeds directly into market entries like FDA 510(k) and other submissions (stage five). One authorized auditing organization audits your system against ISO 13485 plus the specific regulatory requirements of the five participating jurisdictions — and each regulator accepts the outcome within its framework.

For exporters the economics are straightforward: fewer regulatory audits, fewer production stoppages for inspection weeks, and a single corrective-action stream instead of five. For Canada it is not optional at all — MDSAP certification is a condition of device licensing.

Our MDSAP readiness work

  1. Jurisdiction mapping — which of the five markets you sell into today and plan to enter, so we prepare only what will be audited.
  2. Gap analysis against the MDSAP audit model — your ISO 13485 system mapped to the program's task-based audit sequence.
  3. Jurisdiction-specific supplements — the additional procedures and records each regulator layers on top of ISO 13485.
  4. Audit rehearsal & support — your team drilled on the audit flow; we support you through the certification audit and findings.

Quoted after gap analysis. Bundling MDSAP readiness with an ISO 13485 implementation is materially cheaper than sequencing them as separate projects.

FAQ

Frequently asked questions

What is MDSAP?
The Medical Device Single Audit Program: one audit by an authorized auditing organization whose outcome is accepted by regulators in five jurisdictions — the USA (FDA), Canada, Brazil, Australia and Japan. For Canada, MDSAP certification is mandatory for market access; for the others it substitutes for or reduces separate regulatory audits.
Do I need ISO 13485 before MDSAP?
Effectively yes — MDSAP audits your quality system against ISO 13485 plus each jurisdiction’s specific requirements. If your ISO 13485 system is genuine (not shelfware), MDSAP is an extension, not a rebuild. We bundle the two engagements for exactly this reason.
Which markets does MDSAP actually unlock?
Canada requires MDSAP certification for device licensing. The US FDA accepts MDSAP audit reports in place of routine surveillance inspections. Brazil’s ANVISA, Australia’s TGA and Japan’s PMDA/MHLW each accept MDSAP evidence within their own frameworks. Note MDSAP covers the quality-system audit — product submissions (like a 510(k)) remain separate.
How disruptive is the MDSAP audit?
It is a structured, task-based audit with a published process model, which makes it very preparable. Our readiness work maps your existing procedures to the MDSAP audit tasks, closes the jurisdiction-specific gaps, and rehearses your team on how the audit day actually runs.
What does MDSAP consulting cost?
It depends on how mature your ISO 13485 system is and which of the five jurisdictions you sell into. Bundled ISO 13485 + MDSAP engagements are the most cost-efficient route — ask for a scoped quotation.

Exporting — or bidding for buyers who do?

Tell us your target markets and current certification. We will tell you whether MDSAP pays for itself in your case — sometimes the honest answer is 'not yet'.

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