What Is MDSAP?

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What is MDSAP?
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Content
What Is MDSAP? The MDSAP Participating Regulators
MDSAP Certification Audit What Are The Benefits
Of MDSAP Certification?
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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 134852016 and their respective regulatory
requirements.
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The purpose of MDSAP is to establish, conduct
and command a single audit program. This allows
a single audit of a medical device manufacturers
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.
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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.
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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

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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.

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To maintain the consistency amongst the MDSAP-reco
gnized 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.
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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.
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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.
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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.
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What Are The Benefits Of MDSAP Certification?
Educes the number of audits and inspections a manu
facturer 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. Consistency of multi
ple, international regulatory programs
by participating regulators.
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