Regulatory topic
MDSAP: one quality audit, five regulators
The Medical Device Single Audit Program lets a manufacturer undergo one quality management system audit that the regulators of Australia, Brazil, Canada, Japan and the United States all rely on. MedTech Signal explains the programme and connects it to the regulator records we hold.
Who takes part
The participating regulators are the TGA (Australia), ANVISA (Brazil), Health Canada, the MHLW and PMDA (Japan) and the US FDA. The EU and the UK MHRA are observers or affiliates rather than full members, so an MDSAP audit does not by itself satisfy EU MDR or UK requirements.
What an MDSAP audit is
An authorised auditing organisation audits the manufacturer's quality system against ISO 13485 plus each participating regulator's specific requirements, on a three-year cycle. Health Canada requires MDSAP certification for most Class II to IV licences; the FDA uses MDSAP reports in place of many routine inspections.
Auditing organisations
Only auditing organisations recognised by the participating regulators may carry out MDSAP audits. The FDA publishes the current list with contact details. Supplier-qualification and audit teams use that list to confirm who may audit a given site.
What MedTech Signal shows today
Individual company MDSAP certificates are mostly not public, so we do not hold them and never state whether a company is or is not MDSAP certified. What you can see is the surrounding evidence: Health Canada licences, FDA inspections, Form 483 observations and warning letters, recalls, and EU and UK registrations for the same company.
Who uses this
Quality and audit teams planning an MDSAP transition, supplier-qualification teams checking a contract manufacturer, and companies entering Canada, where MDSAP is effectively mandatory.
MDSAP certificates are not imported because they are not publicly published. Related records held: Health Canada MDALL licences, FDA inspections, warning letters and recalls, EUDAMED and MHRA registrations. Official programme information: fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap.