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Key Benefits

How it Works

Ending its pilot phase and becoming fully implemented in January 2017, the Medical Device Single Audit Program (MDSAP) is an initiative of the Therapeutic Goods Administration of Australia (TGA), the Brazilian Agência Nacional de vigilância sanitária (ANVISA), Health Canada (HC), United States Food and Drug Administration (FDA) and Japan's Ministry of Health Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).

The MDSAP model allows recognized Auditing Organizations to conduct a single audit that satisfies compliance requirements and regulatory requirements of participating authorities. This means that the MDSAP audit report can substitute routine agency inspections.

The implementation of MDSAP consists of three key stages, including the initial audit (stage 1 and 2), surveillance audits and recertification audit. 

Initial Audit
The initial certification audit consists of a Stage 1 and Stage 2 audit.
In the Stage 1 audit, the auditor will review documentation, and evaluate your preparedness for the Stage 2 audit.
The Stage 2 audit determines whether all ISO 13485 and regulatory requirements are met. It evaluates the implementation and effectiveness of your quality management system.

Surveillance Audit
Surveillance Audits are conducted between the Initial and Recertification Audit, to assure that all applicable requirements are continually being met. These audits are generally conducted 12 months apart.

Re-Audit
A Re-audit, or Recertification Audit, is conducted every three years to confirm the continued relevance, applicability and suitability of the organizations quality management, and that it meets all applicable requirements.
Re-audits do not require a Stage 1 audit, unless significant changes have occurred since the last audit.

Special Audits
These audits are not part of the planned audit cycle. These audits are generally conducted when an application for the extension of scope is submitted. They can also be used to investigate significant complaints or non-conformities.

Unannounced Audits
Unannounced Audits are conducted by Auditing Organizations when the regulatory authority detects high grade non-conformities.

Non-Conformities
Non-conformities are based off a grade or score ranging from 1-5. This is calculated in a two step grading system.
The first step grades between 1 to 4 based off the indirect or direct impact. The second step adds an additional grade if there is a lack of documented process, and/or a release of a non-conforming medical device

The five Regulatory Authorities participating in the MDSAP include:

Canada
As of January 1, 2019, Health Canada only accepts an MDSAP certificate for Class II, III and IV medical devices. Health Canada has made the MDSAP mandatory for regulatory submission.

United States
The MDSAP can be used as a substitute to an FDA inspection, however it does not apply to "For Cause" or "Compliance Follow-up"inspections.

Australia
The TGA can accept the MDSAP report as part of the evidence required for compliance with ISO 13485, and may request additional documents.

Brazil
If a previous ANVISA inspection is deemed satisfactory, the MDSAP report can be used as an alternative to an ANVISA inspection.

Japan
The MDSAP audit report is used as a trial to exempt some manufacturers from on-site inspections.

We can help your organization certify to the Medical Device Single Audit Program. 

Start
If you have pending questions, review the MDSAP FAQ

 Implement

  • Contact SAI Global to discuss requirements, timeframes and costs
  • Perform an optional pre-assessment
  • Perform a gap analysis

Certify

  • Undertake a Stage 1 audit
  • Complete a detailed Stage 2 audit
  • Upon successful certification, display the 'Five Ticks' StandardsMark™
  • Regulatory notification of successful achievement of MDSAP

Maintain

  • Conduct annual Surveillance Audits
  • Recertify to the MDSAP + ISO 13485 every three years
  • Establish a continuous improvement culture

Optimize

  • Market for brand and promotional benefits
  • Optimize commercial teams
  • Ensure shareholder and stakeholder awareness

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