MDSAP Country Specific Requirements (Canada)

Description:

Health Canada is the agency of the Canadian government that is responsible for national health policy and compliance, among other obligations. The agency has been a participating member of the MDSAP consortium working group, the International Medical Device Regulators Forum (IMDRF), in developing the MDSAP program. Canada’s transition to MDSAP was initially announced in 2015, confirming the requirement for medical device manufacturers to transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP in order to continue to place devices within Canada.

Curriculum for this course:
Introduction
Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Who Should Take This Program? 1 min 21 secs
Glossary 1 min 10 secs
MDSAP Basics 1 mins 11 secs
MDSAP Audit Model 1 min 09 secs
MDSAP and Canada (HC) 1 mins 10 secs
Chapter 1 – Process: Management
Auditing the Management Process 1 min 05 sec
Audit Task 5 1 min 10 secs
Chapter 2 – Process: Device Marketing Authorization and Facility Registration
Auditing the Device Marketing Authorization and Facility Registration Process 1 min 12 secs
Audit Task 1 1 mins 29 secs
Audit Task 2 1 min 02 secs
Audit Task 3 1 min 25 secs
Chapter 3 – Process: Measurement, Analysis and Improvement
Auditing the Measurement, Analysis and Improvement Process 1 min 01 secs
Audit Task 7 1 min 13 secs
Audit Task 12 1 min 33 secs
Chapter 4 – Process: Medical Device Adverse Events and Advisory Notices Reporting
Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process 1 min 10 secs
Audit Task 1 1 min 01 secs
Audit Task 2 1 min 25 secs
Chapter 5 – Process: Design and Development
Auditing the Design and Development Process 1 min 23 secs
Audit Task 1 1 min 50 secs
Audit Task 3 1 min 06 secs
Audit Task 13 1 min 35 secs
Chapter 6 – Process: Production and Service Controls
Auditing the Production and Service Controls Process 1 min 01 secs
Audit Task 16 1 min 02 secs
Audit Task 18 1 min 10 secs
Audit Task 25 1 min 15 secs
Conclusion
Final Assessment
Certification
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