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Content What Is MDSAP? The MDSAP Participating Regulators MDSAP Certification Audit What Are The Benefits Of MDSAP Certification?

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 regulatory requirements.

“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.

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.

The MDSAP Participating Regulators Australian Therapeutic Goods Administration The Brazilian National Health Surveillance Agency ANVISA Health Canada US Food And Drug Administration, Centre For Devices And Radiological Health (CDRH) Japan Ministry Of Health, Labor And Welfare 1. 2. 3. 4. 5.

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.

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. To maintain the consistency amongst the MDSAP-recognized Auditing Organizations, they should follow the MSDAP Audit plan:

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.

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.

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.

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. Consistency of multiple, international regulatory programs by participating regulators.

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