The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.
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2. Content
What Is MDSAP?
The MDSAP Participating
Regulators MDSAP Certification
Audit
What Are The Benefits Of MDSAP
Certification?
3. What Is MDSAP?
The Medical Device Single Audit
Program (MDSAP) is a harmonised
approach to auditing and monitoring
the quality management systems of
medical device manufacturers on an
international scale. It was
developed by a group of medical
device regulators (the IMDRF) to
recognise third-party auditors to
conduct a single audit of a medical
device manufacturer that will cover
ISO 13485:2016 and their respective
4. “The purpose of MDSAP is to establish, conduct and
command a single audit program.” This allows a single
audit of a medical device manufacturer’s QMS which
satisfies the requirements of multiple regulatory
jurisdictions. MDSAP Audits are conducted by Auditing
Organizations (AO), authorized by the participating
Regulatory Authorities (RA) to audit under MDSAP
requirements. Accordingly, Medical Device Single Audit
Program (MDSAP) audit reports may be used by regulatory
authorities in lieu of their own inspection reports.
The current MDSAP program participants include: USA,
Canada, Australia, Japan and Brazil.
5. MDSAP is a way that medical device
manufacturers can be audited once for
compliance with the standard and regulatory
requirements of up to five different medical
device markets: Australia, Brazil, Canada,
Japan and the United States.
6. The MDSAP Participating
Regulators
1.Australian Therapeutic Goods Administration
2.The Brazilian National Health Surveillance Agency
ANVISA
3.Health Canada
4.US Food And Drug Administration, Centre For Devices
And Radiological Health (CDRH)
5.Japan Ministry Of Health, Labor And Welfare
7. MDSAP Certification Audit
MDSAP Audits are conducted annually, according to a
three-year MDSAP certification cycle, by approved
auditing organizations (notified bodies). “An initial
MDSAP certification audit is conducted by MDSAP-
recognized Auditing Organizations which will be followed
by annual surveillance audits”. MDSAP Audit time is
based on tasks, not employee count, with an average of
15 minutes per task.
8. To maintain the consistency amongst the
MDSAP-recognized Auditing Organizations, they should
follow the MSDAP Audit plan:
Performing MDSAP audits in a uniform manner by auditing
organizations.
Focusing on the interaction of process by conducting
reasonable and productive MDSAP audits.
Quality management system nonconformities are identified
precisely by the MDSAP auditors.
9. All MDSAP audit reports must be submitted to all
regulators. As part of the MDSAP program, regardless of
the outcome, all regulators will be reviewing the reports.
Additionally, a database will be set up for these reports,
so any of the participating countries can review reports
associated with a particular organization or medical
device, as well as trending nonconformities.
10. In most cases, the manufacturer must provide a remediation
plan for each non-conformance within 15 calendar days of
the date the nonconformity report was issued. In cases
involving grade 4 or grade 5 nonconformities, final
response — with evidence of effective corrective action —
must be provided within 30 days of the last day of the
audit.
11. MDSAP Auditing organizations are expected to provide an
audit package, which includes non-conformance grading,
to regulatory authorities within 45 days of the end of the
audit.
12. What Are The Benefits
Of MDSAP Certification?
Educes the number of audits and inspections a
manufacturer must undergo.
Efficient, single audit scheme minimises business
disruptions, reduces costs and saves time.
Expedites entrance into some markets where
traditional regulatory oversight can cause
significant delays.
Consistencyof multiple, international
regulatory programs by