This course is equivalent to 39 hours of learning and covers the following:
1.Scope of the NHP Regulation
2.Product classification
3.Product Licensing
4.Site Licensing
5.GMP
6.Labeling and Packaging
7.Importation for sale in Canada
8.Distribution
9.Clinical Trials
10.Adverse Event Reporting
Course outline:
- Laws and Regulations
- Quality System
- Software
- Combination and IVD Devices
- 510 Premarket Notification
- Device Modification
- PMA
- Clinical IDE and HDE
- Compliance with FDA
- Imports and Exports
- Working with FDA
Preparation of modules 1 to 5 of the eCTD for drug submission.
This certificate covers the following outlines:
1- Healthcare product types
2- Stages of healthcare product life cycle
3- Common responsibilities of RA professionals
4- Regulatory agencies in major regulatory systems and timelines for drug registrations
5- Introduction to eCTD
6- Post approval activities and compliance
Post-Graduate Certificate in Medical Devices Regulations - Canada
Topics:
- Medical Devices Regulation and device classification (Canada)
- Establishment license, labelling requirements and Importation
- Mandatory reporting (Incident reporting for medical devices: Guidance Document)
- Foreign Risk Notification for Medical Devices Guidance Document
- Guidance on Summary Report and issue-related analysis for Medical Devices
- Professor: Peivand Pirouzi