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.
