Market Overview

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes Seminar (Jersey City, New Jersey, United States - October 11-12, 2018) -


The "Medical
Device Single Audit Program [MDSAP] Implementation & Participating
Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan:
2-Day In-Person Seminar"
conference has been added to's

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.

This two-day seminar is focused on understanding the Medical Device
Single Audit Program, the scope of the program, how to apply, the
Authorized Organizations, the rating system developed and what you can
expect when signing onto the program. The seminar will discuss how such
audits are organized, what to expect during a MDSAP audit, how does this
differ from a typical certified body audit, along with document movement
and timeline expectations in receiving the facility's certificate.

The key Regulatory Requirements for Medical Devices will also be covered
for the participating MDSAP Countries of: 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

This seminar will be particularly useful for those involved in research
and development, document creation for regulatory submission, data
handling and for those conducting/monitoring/coordinating clinical
investigation, performing risk management and post-market
vigilance/surveillance. This seminar is a must for those who are looking
to apply for a medical device registration and product license in a
MDSAP country.

For more information about this conference visit

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