This webinar will help you understand the process for obtaining a Canadian Medical Device License. You will learn best practices for determining which device classification is appropriate for your device, which guidance documents you will need, best practices in preparing regulatory submissions for Class 3 and 4 products, which labeling changes your company needs to make, and the most effective approach for responding to requests for additional information.
Why Should You Attend:
Canada is usually the best market to target for a new medical product introduction. There are four reasons for this. First, the users are similar to the larger markets of the US and Europe. Second, the Canada regulations are simpler to learn. Third, the process for obtaining a medical device license is less burdensome than the 510(k) process in the USA and the CE Marking process in Europe. Fourth, the Canadian market is an ideal size for a pilot commercial product launch.
This webinar will provide valuable assistance to all medical device companies in preparing a Canadian Medical Device License Application. The focus will be upon creating an outline of the tasks that need to be completed — without confusing everyone with regulatory jargon. This is a prerequisite for any company that wants to sell a Class 2, 3 or 4 medical device in Canada.
Areas Covered in the Webinar:
The webinar will include the following critical information you will need:
How to determine your device classification—and how to double check your conclusion.
How to format you licensing submission.
Best practices in writing a Summary Technical Document (STED).
Current trends in requests for additional information.
When to contact Health Canada and when to “sit and wait”
How long it will take you to obtain a Canadian Medical Device License.
Who will Benefit:
This topic applies to personnel/ companies in the medical device industry. The employees who will benefit most include:
Added by complianceonlinecom on November 7, 2012