MDSAP Certification Process: One Audit for Five Markets
We prepare medical device and IVD manufacturers for the Medical Device Single Audit Program: gap analysis against all five regulators, QMS updates, auditing organisation selection, audit support and fast responses to nonconformities.
What is the MDSAP certification process?
The Medical Device Single Audit Program (MDSAP) lets one audit of your quality management system satisfy five regulators at once. The audit is carried out by an MDSAP-recognised auditing organisation against ISO 13485:2016 plus each country's specific requirements.
It is mandatory for Class II to IV device licences in Canada and voluntary elsewhere, but it can replace routine FDA inspections and reduce audits by the TGA, ANVISA and the Japanese authorities.
How each MDSAP regulator uses the audit
The same audit report is used differently in each market.
| Regulator | Country | How MDSAP is used |
|---|---|---|
| Health Canada | Canada | Required for Class II, III and IV device licences |
| FDA | USA | Audit reports accepted in place of routine inspections |
| TGA | Australia | Certificates and reports used as evidence in market authorisation |
| ANVISA | Brazil | Reports used for GMP certification, reducing ANVISA inspections |
| MHLW / PMDA | Japan | Reports used in QMS conformity assessment, reducing on-site inspections |
The 7 processes in an MDSAP audit
The MDSAP certification process, step by step
From readiness to a certificate, then through the three-year cycle.
- 1
Gap analysis
All 5 regulatorsWe compare your QMS with ISO 13485 and each country’s requirements, including the FDA QMSR.
- 2
QMS updates
Country-specificWe add procedures for registration, adverse event reporting, labelling and record retention in each market.
- 3
Choose an auditing organisation
MDSAP-recognisedWe help you compare recognised auditing organisations on scope, availability and cost.
- 4
Internal MDSAP audit
ReadinessWe run a mock MDSAP audit using the official audit model and close the gaps.
- 5
Initial audit (Stage 1 & 2)
CertificationThe auditing organisation reviews documentation, then audits implementation on site.
- 6
Nonconformity responses
15 / 30 daysWe prepare your remediation plan within 15 days and evidence within 30 days.
- 7
Surveillance & recertification
Years 2 and 3We support annual surveillance audits and recertification before the cycle ends.
Common MDSAP audit findings
Our MDSAP services
MDSAP certification process FAQs
Which countries take part in MDSAP?
Five regulators: Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW and PMDA) and the USA (FDA). One MDSAP audit covers the QMS requirements of all five.
Is MDSAP mandatory?
Only for Canada. Health Canada requires an MDSAP certificate for Class II, III and IV medical device licences. For the other four regulators it is voluntary, but it can replace or reduce their own inspections.
How is MDSAP different from ISO 13485 certification?
MDSAP audits against ISO 13485 plus the specific QMS requirements of each participating country, such as FDA QMSR, Canadian, Brazilian and Japanese rules. An MDSAP audit can also give you an ISO 13485 certificate from the same auditing organisation.
How long does an MDSAP certificate last?
MDSAP runs on a three-year cycle: an initial audit, annual surveillance audits in years two and three, and a recertification audit before the third anniversary.
How quickly must I respond to MDSAP nonconformities?
You normally need to send a remediation plan within 15 calendar days of the audit and evidence of implementation within 30 calendar days. Higher-grade findings are reported to the regulators and can lead to special audits.
How long does it take to prepare for MDSAP?
If you already hold ISO 13485 certification, preparing for MDSAP typically takes 2 to 3 months, mainly to add country-specific requirements for registration, adverse event reporting and labelling.
Is your QMS ready for MDSAP?
Send us your details using the form below and we'll run a free MDSAP readiness check.
