Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

Why Should You Attend:

This 90-minute webinar is focused on understanding the Medical Device Single Audit Program (MDSAP), 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 webinar 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.

Highlights of the key regulatory requirements for medical devices will also be covered for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan.

Topics to be Discussed:

• 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

Areas Covered in the Webinar:

• Introduction and Agenda Review
• Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
• U.S. FDA - Overview of Medical Device Regulations
• Device Classification, Licensing Pathways, Human Factors and Usability Studies, Medical Device GMP, Inspection Process, Device Labeling, Combination Products, License Holder Responsibilities
• (NOTE: Each country session will follow a similar format to the information above)
• Canada - Overview of Health Canada Medical Device Regulations
• Brazil - Overview of ANVISA Medical Device Regulations
• Australia - Overview of TGA Medical Device Regulations
• Japan - Overview of PMDA Medical Device Regulations
• Working with Country Regulators
• Q&A Session

Who Will Benefit:

This 90-minute webinar will provide invaluable assistance to all personnel in the medical device industry, who have a stake in expanding their business into a MDSAP participating country and for those interested in more information about MDSAP and how it may apply to them.

This webinar 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 webinar is a must for those who are looking to apply for a medical device registration and product license in a MDSAP country. Employees who will significantly benefit by attending this training include:

• Regulatory Affairs Personnel
• Quality Assurance, Quality Control, and Quality Systems Professionals
• Product Development Personnel
• Contract Research Organizations Personnel
• Business Management
• Site Managers
• Senior and Executive Management
• Contractors and Subcontractors
• Distributors
• Consultants