MDSAP

MDSAP Country Specific Requirements (Canada)

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.

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CEU Credits: 0.1

Course Code: ELM-142

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V2.0

Effective Date: 04/04/2023

Curriculum for this course

Introduction

Overview

Learning Objectives

Who Should Take This Program?

Glossary

MDSAP Basics

MDSAP Audit Model

MDSAP and Canada (HC)

Chapter 1 – Process: Management

Auditing the Management Process

Audit Task 5

Chapter 2 – Process: Device Marketing Authorization and Facility Registration

Auditing the Device Marketing Authorization and Facility Registration Process

Audit Task 1

Audit Task 2

Audit Task 3

Chapter 3 – Process: Measurement, Analysis and Improvement

Auditing the Measurement, Analysis and Improvement Process

Audit Task 7

Audit Task 12

Chapter 4 – Process: Medical Device Adverse Events and Advisory Notices Reporting

Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process

Audit Task 1

Audit Task 2

Chapter 5 – Process: Design and Development

Auditing the Design and Development Process

Audit Task 1

Audit Task 3

Audit Task 13

Chapter 6 – Process: Production and Service Controls

Auditing the Production and Service Controls Process

Audit Task 16

Audit Task 18

Audit Task 25

Conclusion

Final Assessment

Certification

Revision History

Course updated to v2.0 on 04/04/2023 to reflect FDA update to MDSAP Audit Approach policy document MDSAP AU P0002.008 including changes to: Audit sequence, management process, measurement analysis and improvement process, medical device adverse events and advisory notices reporting, design and development process and production and service controls