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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 2025100+ devices registered
Medical Device Consultant.MY
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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, and it builds straight onto the ISO 13485 system we already run for you.

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 CE marking under EU MDR (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 own framework.

For a Malaysian manufacturer the economics are straightforward: fewer regulatory audits, fewer production stoppages for inspection weeks, and a single corrective-action stream instead of five. Because MDSAP is audited against the ISO 13485 quality system as its base, it is the easiest export step to add once that QMS is genuinely running — which is exactly why we bundle the two. For Canada it is not optional at all: MDSAP certification is a condition of holding a medical device licence.

The team at a GDPMD certification milestone
A certification milestone — MDSAP audits the same QMS core.
Consultants reviewing medical-device submission documents at a meeting table
Mapping existing procedures to the MDSAP audit tasks.

What MDSAP covers across the five jurisdictions

MDSAP is a single quality-system audit, but each regulator recognizes it in its own way. Understanding which markets you are actually entering keeps the scope — and the cost — honest.

  • Canada (Health Canada) — MDSAP certification is mandatory to hold a medical device licence.
  • USA (FDA) — MDSAP audit reports are accepted in place of routine FDA surveillance inspections.
  • Brazil (ANVISA) — MDSAP audit reports are recognized within ANVISA’s good-manufacturing-practice process.
  • Australia (TGA) — MDSAP evidence is accepted toward the TGA’s conformity-assessment requirements.
  • Japan (MHLW / PMDA) — MDSAP audit reports are accepted to streamline the Japanese QMS inspection.

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 actually be audited.
  2. Gap analysis against the MDSAP audit model — your ISO 13485 system mapped to the program's task-based audit sequence, with a findings report and a scoped quotation.
  3. Jurisdiction-specific supplements — the additional procedures and records each regulator layers on top of ISO 13485 (for example device licensing, vigilance and reporting obligations per market).
  4. Internal audit & audit rehearsal — we internal-audit the system the way the auditing organization will, and drill your team on the audit flow.
  5. Certification audit support — we sit in the room (or on the call) for the MDSAP audit and manage any findings through to closure.

What MDSAP readiness costs

MDSAP is quoted after a gap analysis, not sold as a fixed package — the cost is driven by how mature your ISO 13485 system is and how many of the five jurisdictions you are entering. Bundling MDSAP readiness with an ISO 13485 implementation is materially cheaper than sequencing them as separate projects, and payment plans from RM1,500/month are available. See how MDSAP sits alongside our published fees on the pricing page.

Get an MDSAP quotation
Jawapan ringkas · Bahasa Malaysia

Apakah MDSAP dan pasaran mana yang dilindunginya?

MDSAP (Medical Device Single Audit Program) ialah satu audit sistem kualiti yang hasilnya diterima oleh pengawal selia di lima pasaran — Amerika Syarikat (FDA), Kanada, Brazil, Australia dan Jepun — jadi pengeluar tidak perlu diaudit berasingan lima kali. Ia diaudit berasaskan sistem ISO 13485 anda, maka ia langkah eksport paling mudah ditambah apabila QMS itu benar-benar berjalan. Bagi Kanada ia wajib untuk lesen peranti; bagi FDA pula ia menggantikan pemeriksaan surveilan rutin. Kos disebut harga selepas analisis jurang — WhatsApp 010-206 2070 untuk perbincangan skop.

AA Alive’s medical-device regulatory team
AA Alive’s device regulatory team, on client visits across Malaysia.
Founder & Managing Director · Regulatory authority

Evin Lim

Advises from the operator’s chair — the group registers, imports and supplies devices itself — and speaks on the Malaysian pharmaceutical and device industry on BERNAMA TV and RTM.

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Commercial Lead · Your first contact

Lim Yen Thong

Your first point of contact for scope, timelines and quotations. Lim Yen Thong runs the commercial side of the device practice and coordinates every engagement from first enquiry to signed proposal.

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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 regulatory 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 — it is the cheapest and fastest route.
Which markets does MDSAP actually unlock?
Canada requires MDSAP certification for a medical device licence. 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) or an EU MDR technical file) remain separate.
Does MDSAP replace CE marking or an FDA 510(k)?
No. MDSAP is a quality-management-system audit, not a product clearance. Your device still needs its own market submission — an FDA 510(k) for the USA, an EU MDR technical file for CE marking — and MDSAP sits underneath those as the audited QMS the reviewers expect to see. See our FDA 510(k) and CE marking (EU MDR) pages for the product route.
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 — so there are no surprises when the auditing organization arrives.
How long does MDSAP readiness take?
It is driven by how mature your ISO 13485 system already is and how many of the five jurisdictions you are entering. A company with a working ISO 13485 QMS is preparing supplements and rehearsing; a company starting the QMS from scratch is running the ISO 13485 build first. We set a realistic date at the gap-analysis stage, not before.
What does MDSAP consulting cost?
It depends on how mature your ISO 13485 system is and which of the five jurisdictions you sell into, so it is quoted after a gap analysis rather than sold as a fixed package. Bundled ISO 13485 + MDSAP engagements are the most cost-efficient route, and payment plans from RM1,500/month are available — 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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