MDSAP stands for the Medical Device Single Audit Program, a joint medical device regulatory audit initiative co-launched by five regulatory authorities: the U.S. FDA, Health Canada, Brazil’s ANVISA, Australia’s TGA and Japan’s PMDA.Its core objective is to conduct a single unified audit to assess medical device manufacturers’ quality management systems (QMS), verifying compliance with regulatory requirements of all participating jurisdictions. After obtaining MDSAP certification, manufacturers can drastically reduce the frequency of separate regulatory inspections, minimize production disruptions caused by repeated audits, and lower overall compliance burdens.
MDSAP AUDIT APPROACH
During MDSAP audits, nonconformities are graded on a scale of 1 to 5, with final ratings determined via escalation rules outlined in the nonconformity scoring matrix. All nonconformity scores are recorded in the Standard Nonconformity Rating and Exchange Table, which also contains detailed guidance on calculating final nonconformity grades based on ISO 13485 clauses.
MDSAP certification application does not require prior possession of other QMS certificates. However, an existing ISO 13485 system foundation will streamline the entire MDSAP certification process significantly.
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Auditing Organizations (AOs) are accredited bodies eligible to issue MDSAP certificates. There are currently 15 authorized AOs as listed below:
Complete Process: Define Target Participating Jurisdictions → Document Preparation Phase → Select Authorized Auditing Organization (AO) → Audit Stage → Certification Decision → Certificate Issuance → Annual Surveillance Audits → Recertification Upon ExpiryCore Document Preparation Checklist：
A: The scope of MDSAP certification can be customized based on your company’s target markets. Any jurisdiction where you currently sell or plan to launch medical devices shall be included in your certification scope. Note: Per Canadian regulations, if no product sales occur in Canada for three consecutive years, the AO will remove Canada from your MDSAP certification scope.
A: MDSAP certification fees vary based on enterprise scale and defined audit scope, with slight pricing differences across different AOs. Submit your company’s detailed operational information to an AO to receive a full formal quotation.
A: Official MDSAP guidance materials are available on the FDA MDSAP international webpage:https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsapAdditional reference documents:
FAQ Navigation Links Where to find MDSAP recommended guidance documents? Cost breakdown of MDSAP certification Is it mandatory to cover all five MDSAP participating countries?