Medical Devices
Implementation of the New Requirements of Health Canada

Navigating the Regulatory and Quality (MDSAP) Pathways

Date: TBA
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00-17:00
Price: 1,950 NIS+VAT
Credit Points: 2
SKU: 19886
Course Language: Hebrew
About the Course
Canada is an important port of entry to the large North American healthcare market. In order to penetrate this market companies developing medical devices must be aware of the new regulatory framework that Health Canada has developed for these products.

Knowledge of the Canadian regulatory requirements for medical devices is crucial for any company involved in their product and clinical development, as well as their commercialization.

The continuous harmonization of the regulatory requirements between Health Canada, the FDA and other regulatory bodies, including the Medical Device Single Audit Program (MDSAP), has led many companies to seek regulatory approvals in Canada in order to penetrate the North American market.

The course will outline additional product development advantages as well as the main Canadian regulatory requirements for:
  • ITA submission
  • Licensing application
  • Establishment of Quality Management Systems
  • Risk management
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
Canada is the ideal location where advanced scientific and medical expertise meet affordable costs. Not only is the Canadian Dollar significantly cheaper than its US counterpart, but there are significant financial incentives for any research and development performed in Canada (including clinical trials). Offering a highly qualified scientific and medical community supplemented with a supportive, timely regulatory environment, Canada is the most cost-competitive country in the G7 to conduct both R&D and clinical development.
Who should attend
Executives and managers involved with:
  • Regulatory affairs
  • Quality assurance
  • Product development
  • Manufacturing
  • Clinical development
Medical Devices
Implementation of the New Requirements of Health Canada
Benefits to the Participants
Gain knowledge about:
  • Canadian regulatory requirements for approval of medical devices including products approved in other jurisdictions
  • The advantages of applying for licensing in Canada
  • 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
Contact us
  • Full Name
  • Email
  • Phone
  • Notes
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Issues to be covered
  • Introduction
    • The Structure of Health Canada
    • The definition of medical devices according to Health Canada
    • Classification of medical devices
  • Canadian regulations of medical devices
  • Comparison of regulatory requirements in Canadian and other jurisdictions (US, EU)
  • Mutual recognition of data between various regulatory authorities
  • Preparation and submission of Pre-ITA, ITA, Licensing application
  • Quality systems according to ISO 13485:2016
  • GMP
  • Risk management according to ISO 14791
  • Clinical trials
    • Types of clinical trials for medical devices
    • Clinical trial regulatory requirements
    • How clinical trials impact the future commercialization of a medical device
    • Record keeping
    • Monitoring
  • Vigilance program
  • Preparation for audits in compliance with Health Canada requirements
  • New Canadian regulatory requirements
    • Transition to ISO 13485:2016
    • Transition to MDSAP
    • Transition to e-submission – Non-eCTD Format
  • Special types of medical devices
About The Lecturer

Ms. Netta Fulga

Ms. Fulga has an MSc. in biochemistry from the Hebrew University in Jerusalem. She is also a Certified Quality Auditor by the American Society of Quality (ASQ). Ms. Fulga has over 25 years experience in bio-pharmaceutical research and development, and bio-medical laboratory management in Israel and in Canada.
For more information please click here

Dr. Valentin Fulga

A graduate of the Ben Gurion medical school in Beer Sheva, Israel, Dr. Fulga is a serial entrepreneur in the life science industry. He has over 20-year experience in the development of medical products, regulatory submissions and clinical trials in various jurisdictions including, Canada, the US and the EU.
For more information please click here

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