This hands-on 2-day course with workshop will give importers, distributors and manufacturers a complete overview of the medical device regulations and quality assurance/system requirements in Canada, to successfully do business in Canada. The course will include Health Canada regulatory requirements (incl. establishment licencing, Device Licence Applications, recall procedures, product quality applications, labelling requirements, risk classification, etc.) and also review none Health Canada requirements, i.e. CSA electrical approval, Transport of Dangerous Goods regulations, MSDS, temperature considerations, etc.
This 2-day course will cover the following topics:
- Overview of the Food and Drug Act / Regulations
- Medical Device Establishment Licencing (why, how etc.)
- Recalls Procedure (what and how)
- MPRS and Complaint procedures (what and how)
- Trade Complaints (what and how)
- Risk Based Classification of Medical Devices
- Labelling requirements for Medical Devices
- Medical Device Application Review process
- Private Labelling
- Special Access Program
- Quality system Requirements for Class II to IV
- Other (None-HC) consideration (CSA, Temperature, Transportation, etc.)
LIMITED SPACE AVAILABLE!
PLEASE REGISTER ASAP TO GUARANTEE A SPOT!
For more information and to register please see:
http://www.psg.ca/index.php?task=courses&courseid=00000438 |