Registration of Medical Devices in Canada, Brazil, Mexico, and Australia
At the end of this training,
- You will acquire know-how about the admission requirements in these countries.
- You will receive valuable assistance for access to sales markets.
Who Should Attend?
- Medical device manufacturers and exporters who wish to distribute their products in these countries
- Employee Regulatory Affairs
Course Agenda
- Overview of the different approval procedures for medical devices in:
- Canada
- Brazil
- Mexico
- Australia
- Regulatory and normative requirements in the individual countries
- Legal basis, directives and regulations
- Standards and guidelines
- Competent authorities and institutions
- Tasks and responsibilities
- Structures
- Classification of medical devices
- Overview of the different authorisation procedures
- First registrations
- Variations to marketing authorisations
- Re-registrations
- Costs and duration of authorisations
Course Description
In one day, you will find out which requirements must be met in Canada, Brazil, Mexico and Australia for your medical devices to be approved by the competent authorities there. After attending the seminar, you will know how to proceed and how to successfully create the necessary documentation for registration.
Methodology
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Learning Assessments
Certificate of attendance from the TÜV SÜD Academy
Prerequisites
Experience with regulations for medical devices.