logo
logo
Loading Events

« All Events

  • This event has passed.

Medical Device Quality and Regulatory Requirements for Importer/Distributor and Manufacturers – Canadian Market Workshop

June 10 @ 9:00 am - 5:00 pm

Medical Device Quality and Regulatory Requirements for Importer/Distributor and Manufacturers – Canadian Market Workshop

Register online

Dates Available

June 10, 2020

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $685.00 + HST

Location

Online

Live interactive and instructor led

Abstract

This comprehensive one-day course provides participants with a solid understanding of the principles behind the Medical Devices Regulations in Canada, and how to apply them to your company’s current processes and procedures. The course provides detailed overview of the regulations and the requirements for Manufactures, Importers and Distributers, wishing to sell medical devices in the Canadian market.

Course Outline

  • Introduction
    • Canadian Medical Devices Regulations
      • Regulatory framework
      • Definitions
  • Medical Devices risk-based classification
    • Rules to classify
    • Medical devices groups
    • IVDD/Non-IVDD
  • Requirements for Manufacturers/Importers/Distributers
    • Medical Device Establishment Licence (MDEL), preparation and submission
    • Medical device complaint handling
    • Mandatory problem reporting
    • Medical device recalls
    • Medical device labeling
  • Medical Device Licence application
    • Requirements, preparation and submission
  • Quality Management Systems (QMS) requirements
    • QMS requirements for Class I medical devices
    • QMS requirements for Class II, III, IV medical devices:
      • Medical Device Single Audit Program (MDSAP) certificate
  • Special types of medical devices
    • Drug-device combination
    • Private label
  • Additional Canadian market requirements
    • Recognized standards
    • Canadian electrical approval
    • Transportation of dangerous goods

Who Should Attend

This One-day course is applicable to Personnel from the following areas:

  • Regulatory Affairs
  • Quality Assurance
  • Validation
  • Quality Control Laboratory
  • Analytical Laboratory
  • Training
  • Contract Laboratory
  • Consultants
  • Manufacturing
  • Packaging and Labeling
  • Distributers and Wholesalers
  • Importers

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Details

Date:
June 10
Time:
9:00 am - 5:00 pm

Connect with AAPS

Join our live, interactive virtual classrooms today!Learn more
+