The course will outline the main Canadian regulatory requirements for:

• ITA submission
• Licensing application
• Establishment of Quality Management Systems
• Risk management

Medical devices companies who develop their products and wish to sell them in the Canadian market, must acquire knowledge of the Canadian regulatory requirements for medical devices. Moreover, in order to be able to commercialize their products, the manufacturer/importer/distributer must be aware of the new regulatory framework that Health Canada has developed for these products.

Harmonization of the regulatory requirements between Health Canada, the FDA and other regulatory bodies, including the new Medical Device Single Audit Program (MDSAP), is continuously evolving and is intended to reduce the regulatory burden on both the manufacturers and the regulators.

During the course we will also discuss:

• The differences and the similarities between medical devices regulations in Canada, the US and the EU
• Canadian regulatory requirements for medical devices as per the new QMS standard ISO 13485:2016
• The transition to MDSAP
• The transition to electronic submission of documentation

Who Should Attend

Personnel involved with:

• Regulatory affairs
• Quality assurance
• Product development
• Manufacturing
• Clinical development

Benefits to the participants:

Gain knowledge about:

• Canadian regulatory requirements for approval of medical devices including products approved in other jurisdictions
• Preparation for and compliance with the new Canadian regulatory requirements for medical devices
• Risk management and quality systems requirements
• Regulatory requirements for clinical trials of medical devices

Certificate of Attendance and Course Material

• All participants will receive a certificate of attendance upon completion of the course.
• The participants will be receiving specially prepared course manual.