Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions. MDSAP requirements align with ISO 13485 along with supplemental QMS requirements in the below major markets.

  • Australia

  • Brazil

  • Canada

  • Japan

  • United States

Medical Device Single Audit Program conducts audits of recognized Auditing Organizations (AOs). AO will conduct an initial certification audit followed by annual surveillance audits every year. After three years, AO will conduct a recertification audit.

MDSAP Structure

MDSAP basically uses ISO 13485:2003 as a framework, in addition to the good manufacturing practise (GMP) requirements of the various regulatory authorities. Auditors follow a structured and logical process approach, with links to other processes as clearly explained in the below attached MDSAP Companion Document. With the introduction of ISO 13485:2016, the Medical Device Single Audit Program (MDSAP) will likely align with the new ISO 13485 standard.

The model includes seven processes:

(a) Primary processes

  • Management,
  • Measurement, Analysis, and Improvement,
  • Design and Development, and
  • Production and Service Controls

(b) Supporting processes

  • Purchasing,
  • Device Marketing Authorization and Facility Registration, and
  • Medical Device Events and Advisory Notices Reporting

Benefits of MDSAP certification

  • Reduces multiple audits by Certification Bodies a manufacturer must undergo for multiple countries.
  • An efficient, single audit scheme minimizes business disruptions, reduces costs and saves time.
  • Faster market penetration where traditional regulatory oversight can cause significant delays.
  • Consistency of multiple international regulatory programs by participating regulators.

Role of MDSAP Consultants

We have trained MDSAP auditors to assess your quality system for the Medical Device Single Audit Program with exceptional technical expertise and experience in the sector specifically qualified professional, effective and competent assessment of your systems.

  • Perform GAP analysis in line with ISO 13485:2003 / 2016 and the quality and regulatory requirements of Australia, Brazil, Canada, Japan & the US.
  • Verify procedures, processes, documentation, supporting objective evidence that the system is effective.
  • Evaluate control over critical suppliers and review adverse event reporting/recall/advisory notice information per country;
  • Prepare a written audit report of our findings.

Regulatory Authorities Participating in MDSAP

USA Flag Canada Flag Australia Flag Japan Flag Brazil Flag

  • United States of America [US FDA]
  • Canada, Health Canada
  • Australia, TGA
  • Japan, MHLW & PMDA
  • Brazil, ANVISA

Europe (EU) has only been an observer in the MDSAP pilot due to concerns that reaching consensus among all member states will be difficult. The EU, on the other hand, is expected to enter the Programme shortly.

Additional Information’s

Companion Document. Link >>>
Medical Device Single Audit Program Frequently Asked Questions

Our Consultation Fees

  1. GAP Assessment – 600 USD/Man-day without travel& Accommodation.
  2. Support for Fixing GAPS and process owner Interaction – 400 USD/Man-day without travel& Accommodation.
  3. Internal Audit –  600 USD/Man-day without travel& Accommodation.
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