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Medical Device Single Audit Program [MDSAP] Implementation (com)

Medical Device Single Audit Program [MDSAP] Implementation (com)

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


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.

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

The Medical Device Single Audit Program (MDSAP)

Device Classification

Licensing Pathways

Medical Device GMP


Device Labeling

License Holder Responsibilities

Timelines and Fees

Country Specific Cultural Considerations and Challenges

Adverse Event Reporting

Who Will Benefit:

This two-day seminar 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 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.

Those employees working in the following roles will significantly benefit by attending:

Regulatory Affairs

Quality assurance, quality control, and quality systems

Product development personnel

Contract research organizations

Business management

Site managers

Senior and executive management

Contractors and subcontractors




Day 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction and Agenda Review
Lecture 1: Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
Program Overview
MDSAP Audit Process
MDSAP Audit Cycle
Country additions to MDSAP Participation
MDSAP Audit Procedures & Forms
Lecture 2: U.S. FDA Overview and Device Regulations
Device Classification
Clinical Trials / IDE
Licensing Pathways: 510k, De Novo, PMA
Human Factors and Usability Studies
Medical Device GMP
Inspection Process
Device Labeling
Combination Products
License Holder Responsibilities
Lecture 3: Canada Medical Device Regulations
Regulatory Authorities & Structure
Device Classification
Import / Export
Marketing Clearance
License Application Types
License Amendments
Establishment License
Quality System Requirements
Clinical Trials
AE Reporting
Packaging & Labeling

Day 02(8:30 AM - 4:30 PM)

Lecture 4: Brazil Medical Device Regulations
Country Overview & facts
Healthcare Authority & Structure
Country Establishment & Licenses
Requirements for Devices
Clinical Trials
Device Classification
Device Registration
Packaging & labeling Requirements
Medical Device Testing
Variations / Amendments / Renewals
Post Marketing Vigilance
Patents & Trademarks
Import / Export
Lecture 5: Australia Medical Device Regulations
Government Structure / Healthcare Authority
Medical Device Regulations
Country Establishment
GMP / Conformity Assessment
Essential Principles
Clinical Trials
Packaging & labeling
Vigilance Reporting
Import / Export
Lecture 6: Japan Medical Device Regulations
Regulatory Agencies & Structure
Agency Consultations
Pharmaceutical & Medical Device Law
Clinical Trials
Business Entities / Country Establishment
Licensing Options
MAH Overview / Personnel
Types of medical Device Licenses
ICH / Japan
Facility Audits
Device Classifications
Device Registration
Device Labeling
Timeline / Fees
Cultural Considerations
Lecture 7: MDSAP Adverse Event Reporting / Common Themes
Lecture 8: Regulatory Process / Working with Global Agencies
Final Questions and Closure


Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.

Please contact the event manager Marilyn (bWFyaWx5biAhIGIgISB0dXJuZXIgfCBueWV2ZW50c2xpc3QgISBjb20= ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

Service fees included in this listing.
This event is brought to you by:
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