Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan (Burlingame CA, United States - June 22-23, 2018) -

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.

One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.

Learning Objectives:

  • The Medical Device Single Audit Program (MDSAP)
  • Device Classification
  • Licensing Pathways
  • Medical Device GMP
  • Inspections
  • Device Labeling
  • License Holder Responsibilities
  • Timelines and Fees
  • Country Specific Cultural Considerations and Challenges
  • Adverse Event Reporting


Introduction and Agenda Review

Lecture 1: Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report

Lecture 2: U.S. FDA Overview and Device Regulations

Lecture 3: Canada Medical Device Regulations

Lecture 4: Brazil Medical Device Regulations

Lecture 5: Australia Medical Device Regulations

Lecture 6: Japan Medical Device Regulations

Lecture 7: MDSAP Adverse Event Reporting / Common Themes

Lecture 8: Regulatory Process / Working with Global Agencies

Final Questions and Closure

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