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The Medical Device Single Audit Program (MDSAP) allows conducting a single Regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple Regulatory regulations. The Regulatory audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to inspect under MDSAP requirements.

Why Was The MDSAP Developed?

  • To maintain appropriate Regulatory oversight of medical device manufacturers’ quality management systems while minimizing the Regulatory burden on industry
  • To promote more competent and flexible use of Regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority
  • To promote a greater alignment of Regulatory approaches and technical requirements based on international standards and best practices at a global level
  • To promote uniformity of Regulatory programs by standardizing;
  • The practices and techniques of participating regulators for the oversight of third-party auditing organizations
  • The practices and guidelines of participating third-party auditing organizations
  • Existing requirements and procedures for conformity assessment

Participants of the MDSAP Program

  1. Australia - TGA
  2. Brazil - ANVISA
  3. Canada - Health Canada
  4. U.S. - FDA
  5. Ministry of Health, Labor and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

Status of MDSAP in Canada

Health Canada has confirmed the requirements for medical device manufacturers to transition from CMDCAS to MDSAP to continue marketing devices in Canada. Starting 1 January 2019 Health Canada will only accept MDSAP for manufacturers who market their devices in Canada. Therefore, manufacturers wishing to continue to place their product in the Canada market in 2019, need to have MDSAP Certification issued by an Auditing organization (AO) in place, before 1 January 2019.

Benefits of MDSAP

  • Minimized medical device manufacturer disruptions due to multiple Regulatory audits
  • Provision of predictable audit schedules
  • Benefits patient health and patient access with ease of entry to multiple markets
  • Leveraging Regulatory resources
  • Incorporation of ISO 13485 assessment
  • Easy access to multiple developed countries across the world like Australia, Brazil, Canada, Japan and the USA
  • Reduced time and resource dealing with findings from multiple audits
  • Reduced cost of audits in comparison to independent audits
  • Improved transparencies

MDSAP is a boon for medical device manufacturers who plan to place their devices in more than one market. But how can a manufacturer apply for MDSAP? What are the eligibility criteria? To know answers to similar questions, contact us at sales@freyrsolutions.com.