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
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 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-142 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: 2.0 -
Effective Date: 04/04/2023
Reviews:
MDSAP is a complex auditing process but broken down like this makes it very easier to understand. This is truly a must do course for anyone selling medical devices in the Canadian market.
Loved the section on measurement, analysis, and improvement. Broken down into digestible blocks this course makes it very easy to understand the MDSAP specific elements that apply to Canada.
Related courses:
Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4
Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7
MDSAP Country Specific Requirements (USA)
Medical Device Single Audit Program (MDSAP) – Part 1
Medical Device Single Audit Program (MDSAP) – Part 2
Medical Device Single Audit Program (MDSAP) – Part 3
How to be an Effective GMP Auditor – Part 1
How to be an Effective GMP Auditor – Part 2
How To Be An Effective GMP Auditor – Part 3
Data Integrity Awareness: Health Authorities
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
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