Why MDSAP Matters:
Introduction of MDSAP
The Medical Device Single Audit Program (MDSAP) enables a recognized Auditing Organization to perform a single, comprehensive regulatory audit of a medical device manufacturer. This audit satisfies the regulatory requirements of all participating authorities, reducing the need for multiple audits by different countries.
The current participating regulatory authorities in MDSAP include:
- Therapeutic Goods Administration (TGA) – Australia
- Agência Nacional de Vigilância Sanitária (ANVISA) – Brazil
- Health Canada – Canada
- Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)- Japan
- U.S. Food and Drug Administration (FDA) – United State
Why was MDSAP Introduced?
The Medical Device Single Audit Program (MDSAP) was introduced with the vision of streamlining global regulatory compliance and enhancing the efficiency of quality management system (QMS) audits for medical device manufacturers. Its goals reflect a commitment to harmonization, transparency, and improved patient safety across multiple jurisdictions.
Below are the key areas where MDSAP offers significant advantages:
How is MDSAP conducted?
The MDSAP Audit Cycle begins with a Stage-1 Audit, which reviews documentation and readiness for certification. This is followed by the Stage-2 Audit, where the full implementation and effectiveness of the Quality Management System are assessed. After certification, the organization undergoes 1st Surveillance Audit in the first year and 2nd Surveillance Audit in the second year to ensure ongoing compliance. If necessary, an Unplanned or Special Audit can be conducted at any stage to address specific concerns or significant changes.
At the end of the cycle, a Recertification Audit (RF-Certification Audit) is performed to renew the certification, after which the cycle repeats.
DIFFERENCE BETWEEN ISO 13485:2016 & MDSAP AUDITING
Parameters
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ISO 13485:2016
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MDSAP
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Scope
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International standard specifying requirements for a Quality Management System (QMS) specific to medical devices.
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An audit program that combines QMS requirements of ISO
13485:2016 with additional regulatory requirements of participating countries
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Participating Countries
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Applicable globally, but not tied to any specific country’s regulations.
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Canada, USA, Brazil, Australia, Japan.
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Non-Conformity grading system
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Classifies nonconformities mainly as Major or Minor without numeric grading.
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Uses Grades 1 to 5 with specific rules for escalation based on
severity and recurrence.
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Medical Device Adverse Event Reporting Timeline
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Not a direct requirement under ISO 13485; handled via other
regulatory frameworks.
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Explicitly includes country-specific adverse event reporting requirements.
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Document
Requirements
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No additional
documentation beyond ISO QMS requirements.
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Requires additional
documentation to meet each country’s regulatory specifics (e.g., language/labeling requirements).
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