Who it’s for
Who should attend
Regulatory affairs and quality staff at manufacturers entering or already supplying Canada, Canadian regulatory correspondents, importers and distributors holding an MDEL, and management responsible for market access.
Curriculum
Course modules
- Health Canada, the Food and Drugs Act and the Medical Devices Regulations
- Classification: Schedule 1 rules, Classes I to IV
- Safety and effectiveness requirements
- Medical Device Licence applications by class; licence amendments
- Medical Device Establishment Licence (MDEL)
- QMS certification requirement and the role of MDSAP
- Labelling requirements, bilingual requirements
- Mandatory problem reporting and annual summary reports
- Recalls
- Investigational testing and Special Access Programme
- Foreign manufacturers and the Canadian regulatory correspondent
Outcomes
What you’ll be able to do
- Classify a device under Schedule 1
- Identify the licensing pathway and evidence required
- Understand ongoing post-market obligations in Canada
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Canadian Medical Devices Regulatory Requirements”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.