Live Virtual Seminar: One-Day Virtual Seminar Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan When: Wednesday May 26 - May 26 , 2021 Duration: 6 Hours.
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 the 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. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.
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
Contact Person: SAM
+1 3156320735